eSubmitter Application History

Version 3.88.00 - Released 01/09/2025
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.

Version 3.87.00 - Released 12/11/2024
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.

Version 3.86.00 - Released 11/08/2024
Enhancements	CDRH: Updated internal device code data stores. CDRH: Updates to 3500A form Blanked out Weight Unit Removed Does not Apply option for C8/C9 Made AE Codes Mandatory (F10 and H6) CDRH: MDR - IMDRF AE Codes Yearly Maintenance.
Fixes	CDRH: 3500A form - Fixed Other Gender XML

Version 3.85.00 - Released 10/10/2024
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Version 3.84.00 - Released 09/12/2024
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Version 3.83.00 - Released 08/08/2024
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Version 3.82.00 - Released 07/11/2024
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Version 3.81.00 - Released 06/06/2024
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Version 3.80.00 - Released 05/02/2024
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Version 3.79.01 - Released 04/19/2024
Enhancements	None.
Fixes	CDRH: Fixed Form 3500A Section F13 Date Format
Version 3.79.00 - Released 04/09/2024
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Version 3.78.00 - Released 03/14/2024
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Version 3.77.00 - Released 02/02/2024
Enhancements	CDRH: Updated internal device code data stores. CDRH: Updates to 3500A form Retired/Removed Field "Form Code" from Section "Report Number". Added new field A3b (Gender). Modified field D4 (Additional UDI Numbers). Added new field F3-5 (Establishment Name). Modified field H9 to accept 50 chars. Repurposed new field H10 (Related Report Numbers). Renamed H10 to H11 (Additional Mfr Narrative). Refreshed eSubmitter AE Codes with 2023-24 IMDRF Codes. Clarified Header/Hint for Section H1. Modified Section H3.
Fixes	CDRH: 3500A form - Resolved bugs in PDF generated.
Version 3.76.01 - Released 01/19/2024
Enhancements	CTP: Tobacco Product Ingredients Listing v2.9: Fixed the "State" dropdown displaying as disabled for the Importer and Manufacturer of Imported Products.
Fixes	None.
Version 3.76.00 - Released 01/05/2024
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Version 3.75.00 - Released 12/08/2023
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.

Version 3.85.00 - Released 10/10/2024
Version 3.84.00 - Released 09/12/2024
Version 3.83.00 - Released 08/08/2024
Version 3.82.00 - Released 07/11/2024
Version 3.81.00 - Released 06/06/2024
Version 3.80.00 - Released 05/02/2024
Version 3.79.01 - Released 04/19/2024
Version 3.79.00 - Released 04/09/2024
Version 3.78.00 - Released 03/14/2024
Version 3.77.00 - Released 02/02/2024
Version 3.76.01 - Released 01/19/2024
Version 3.76.00 - Released 01/05/2024
Version 3.75.00 - Released 12/08/2023
Version 3.62.00 - Released 12/06/2022
Version 3.61.01 - Released 11/17/2022
Version 3.61.00 - Released 11/07/2022
Version 3.60.00 - Released 10/06/2022
Version 3.59.01 - Released 09/16/2022
Version 3.59.00 - Released 09/06/2022
Version 3.58.00 - Released 08/19/2022
Version 3.57.00 - Released 08/09/2022
Version 3.56.00 - Released 07/06/2022
Version 3.55.00 - Released 06/08/2022
Version 3.54.00 - Released 05/05/2022
Version 3.53.00 - Released 04/05/2022
Version 3.52.00 - Released 03/07/2022
Version 3.51.00 - Released 03/04/2022
Version 3.50.00 - Released 02/07/2022
Version 3.49.00 - Released 01/05/2022
Version 3.48.00 - Released 12/06/2021
Version 3.47.01 - Released 11/12/2021
Version 3.47.00 - Released 11/05/2021
Version 3.46.00 - Released 10/07/2021
Version 3.45.04 - Released 09/13/2021
Version 3.45.03 - Released 09/12/2021
Version 3.45.02 - Released 09/10/2021
Version 3.45.01 - Released 09/09/2021
Version 3.45.00 - Released 09/07/2021
Version 3.44.01 - Released 08/18/2021
Version 3.44.00 - Released 08/09/2021
Version 3.43.00 - Released 07/07/2021
Version 3.42.00 - Released 06/05/2021
Version 3.41.00 - Released 05/05/2021
Version 3.40.00 - Released 04/05/2021
Version 3.39.01 - Released 03/19/2021
Version 3.39.00 - Released 03/05/2021
Version 3.38.00 - Released 02/05/2021
Version 3.37.00 -Released 01/05/2021
Version 3.36.01 - Released 12/18/2020
Version 3.36.00 - Released 12/05/2020
Version 3.35.00 - Released 11/20/2020
Version 3.34.00 - Released 11/05/2020
Version 3.33.00 - Released 10/05/2020
Version 3.32.02 - Released 09/11/2020
Version 3.32.01 - Released 09/05/2020
Version 3.31.02 - Released 08/05/2020
Version 3.30.02 - Released 07/08/2020
Version 3.30.01 - Released 07/04/2020
Version 3.29.02 - Release 06/12/2020
Version 3.28.00 - Released 05/05/2020
Version 3.27.00 - Released 04/05/2020
Version 3.26.00 - Released 03/07/2020
Version 3.25.00 - Released 02/07/2020
Version 3.24.00 - Released 01/06/2020
Version 3.23.00 - Released 12/07/2019
Version 3.22.00 - Released 11/05/2019
Version 3.21.00 - Released 10/07/2019
Version 3.20.00 - Released 09/05/2019
Version 3.19.00 - Released 08/05/2019
Version 3.18.00 - Released 07/07/2019
Version 3.17.01 - Released 06/11/2019
Version 3.17.00 - Released 06/05/2019
Version 3.16.00 - Released 05/06/2019
Version 3.15.00 - Released 04/07/2019
Version 3.14.00 - Released 03/05/2019
Version 3.12.00 - Released 01/05/2019
Version 3.11.00 - Released 12/05/2018
Version 3.10.00 - Released 11/05/2018
Version 3.09.00 - Released 10/08/2018
Version 3.08.00 - Released 09/05/2018
Version 3.07.00 - Released 08/06/2018
Version 3.06.00 - Released 07/05/2018
Version 3.05.00 - Released 06/07/2018
Version 3.04.00 - Released 05/05/2018
Version 3.03.01 - Released 04/22/2018
Version 3.03.00 - Released 04/05/2018
Version 3.02.01 - Released 03/28/2018
Version 3.02.00 - Released 03/05/2018
Version 3.01.01 - Released 02/20/2018
Version 2.51.00 - Released 02/05/2018
Version 3.00.00 - Released 01/05/2018
Version 2.50.00 - Released 01/05/2018
Version 2.49.00 - Released 12/05/2017
Version 2.48.00 - Released 11/03/2017
Version 2.47.02 - Released 10/23/2017
Version 2.47.01 - Released 10/11/2017
Version 2.47.00 - Released 10/05/2017
Version 2.45.01 - Released 08/21/2017
Version 2.45.00 - Released 08/07/2017
Version 2.44.02 - Released 07/18/2017
Version 2.44.01 - Released 07/14/2017
Version 2.44.00 - Released 07/05/2017
Version 2.43.02 - Released 06/16/2017
Version 2.43.01 - Released 06/13/2017
Version 2.43.00 - Released 06/05/2017
Version 2.42.04 - Released 05/30/2017
Version 2.42.03 - Released 05/25/2017
Version 2.42.02 - Released 05/18/2017
Version 2.42.01 - Released 05/12/2017
Version 2.42.00 - Released 05/05/2017
Version 2.41.00 - Released 04/05/2017
Version 2.40.01 - Released 03/16/2017
Version 2.40.00 - Released 03/06/2017
Version 2.39.01 - Released 02/14/2017
Version 2.39.00 - Released 02/06/2017
Version 2.38.03 - Released 01/20/2017
Version 2.38.02 - Released 01/10/2017
Version 2.38.01 - Released 01/06/2017
Version 2.37.01 - Released 12/05/2016
Version 2.36.01 - Released 11/07/2016
Version 2.35.02 - Released 10/14/2016
Version 2.35.01 - Released 10/05/2016
Version 2.34.04 - Released 09/28/2016
Version 2.34.03 - Released 09/16/2016
Version 2.34.02 - Released 09/13/2016
Version 2.34.01 - Released 09/09/2016
Version 2.33.02 - Released 08/29/2016
Version 2.33.01 - Released 08/05/2016
Version 2.32.01 - Released 07/01/2016
Version 2.31.03 - Released 06/24/2016
Version 2.31.02 - Released 06/19/2016
Version 2.31.01 - Released 06/03/2016
Version 2.30.01 - Released 05/05/2016
Version 2.29.03 - Released 04/22/2016
Version 2.29.02 - Released 04/11/2016
Version 2.29.01 - Released 04/05/2016
Version 2.28.01 - Released 03/21/2016
Version 2.27.01 - Released 02/19/2016
Version 2.26.01 - Released 01/05/2016
Version 2.25.01 - Released 12/07/2015
Version 2.24.03 - Released 11/27/2015
Version 2.24.02 - Released 11/13/2015
Version 2.24.01 - Released 11/05/2015
Version 2.23.01 - Release 10/07/2015
Version 2.22.02 - Released 9/15/2015
Version 2.22.01 - Released 9/04/2015
Version 2.21.06 - Released 8/19/2015
Version 2.21.05 - Released 8/16/2015
Version 2.21.04 - Released 8/12/2015
Version 2.21.03 - Released 8/11/2015
Version 2.21.02 - Released 8/09/2015
Version 2.21.01 - Released 8/05/2015
Version 2.20.02 - Released July 9, 2015
Version 2.20.01 - Released July 8, 2015
Version 2.19.04 - Released June 24, 2015
Version 2.19.03 - Released June 9, 2015
Version 2.19.02 - Released June 8, 2015
Version 2.19.01 - Released June 5, 2015
Version 2.18.03 - Released May 13, 2015
Version 2.18.02 - Released May 8, 2015
Version 2.18.01 - Released May 5, 2015
Version 2.17.03 - Released April 29, 2015
Version 2.17.02 - Released April 9, 2015
Version 2.17.01 - Released April 6, 2015
Version 2.16.02 - Released March 25, 2015
Version 2.16.01 - Released March 5, 2015
Version 2.15.01 - Released February 5, 2015
Version 2.14.02 - Released January 12, 2015
Version 2.14.01 - Released January 7, 2015
Version 2.13.07 - Released January 2, 2015
Version 2.13.06 - Released December 31, 2014
Version 2.13.05 - Released December 23, 2014
Version 2.13.04 - Released December 19, 2014
Version 2.13.03 - Released December 16, 2014
Version 2.13.02 - Released December 9, 2014
Version 2.13.01 - Released December 5, 2014
Version 2.12.01 - Released November 7, 2014
Version 2.11.01 - Released October 6, 2014
Version 2.10.01 - Released September 8, 2014
Version 2.09.02 - Released August 22, 2014
Version 2.08.01 - Released July 7, 2014
Version 2.07.03 - Released June 13, 2014
Version 2.07.01 - Released June 5, 2014
Version 2.06.01 - Released May 5, 2014
Version 2.05.02 - Released April 28, 2014
Version 2.05.01 - Released April 7, 2014
Version 2.04.02 - Released March 10, 2014
Version 2.02.02 - Released January 29, 2014
Version 2.02.01 - Released January 6, 2014
Version 2.01.01 - Released December 5, 2013
Version 2.00.01 - Released November 5, 2013
Version 1.99.01 - Released September 12, 2013
Version 1.98.02 - Released August 21, 2013
Version 1.98.01 - Released August 16, 2013
Version 1.97.01 - Released July 19, 2013
Version 1.96.02 - Released June 27, 2013
Version 1.96.01 - Released June 11, 2013
Version 1.95.01 - Released May 17, 2013
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	None.
Fixes	CDRH: Fixed Form 3500A Section F13 Date Format
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores. CDRH: Updates to 3500A form Retired/Removed Field "Form Code" from Section "Report Number". Added new field A3b (Gender). Modified field D4 (Additional UDI Numbers). Added new field F3-5 (Establishment Name). Modified field H9 to accept 50 chars. Repurposed new field H10 (Related Report Numbers). Renamed H10 to H11 (Additional Mfr Narrative). Refreshed eSubmitter AE Codes with 2023-24 IMDRF Codes. Clarified Header/Hint for Section H1. Modified Section H3.
Fixes	CDRH: 3500A form - Resolved bugs in PDF generated.
Enhancements	CTP: Tobacco Product Ingredients Listing v2.9: Fixed the "State" dropdown displaying as disabled for the Importer and Manufacturer of Imported Products.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None
Enhancements	1.    CTP: Transmittal v2.3 template - PRA text and OMB expiration date updates to Submission content: OM, SE, AS, EX, PM and PX. 2.    CTP: Tobacco Health Document/Requested Document Submission v1.1 - PRA/OMB text update. 3.    CTP: Tobacco Product Ingredient Listing v2.9 - PRA/OMB text update. 4.    CTP: Tobacco 904(A)(3)(HPHC) template v1.8 - Text update.
Fixes	None
Enhancements	CTP: Updated CTP Transmittal Form v2.3 template.
Fixes	None
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None
Enhancements	CTP: Updated CTP Transmittal Form V2.3 template.
Fixes	None
Enhancements	1.    CDRH: Updated internal device code data stores. 2.    CTP: Updated Tobacco 904(A)(3) (HPHC) Template for OMB expiration date.
Fixes	None
Enhancements	1.    CDRH: MDR - HECC and DPC are mandatory for INITIAL reports 2.    CDRH: MDR - Suggestion that Contact Office Email is mandatory. 3.    CDRH: MDR - IMDRF AE Codes Yearly Maintenance. 4.    CDRH: MDR - Suggestion that Implanted Date is less than equal to Explanted Date. 5.    CTP: Updated Tobacco Product Ingredient Listing form (TI), 904(A)(3) (HPHC), and Health Document/Requested Document Submission (HD) templates for OMB expiration dates. 6.    CTP: The CTP Transmittal Form has been updated to replace 'Grandfathered' as a selectable submission type with the new 'Pre-Existing Tobacco Product' option.
Fixes	None
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None
Enhancements	CDRH: Updated internal device code data stores.
Fixes
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None
Enhancements	1.    CDRH: MDR - Increased ALL phone extension fields to accept 5 digits. 2.    CDRH: MDR - Increased the length of "Establishment Name" under "G1 Continued" from 50 to 60 chars. 3.    CDRH: MDR - Improved D2 product code filter to perform partial search. 4.    CDRH: MDR - E3 value: Removed “If Other, please specify” option.  5.    CDRH: MDR - Increased the field "Exemption Number" to accept 10 chars.
Fixes	CDRH: Fixed validation in H1 for report type supplements.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None
Enhancements	CDRH: Removed IVD Turbo 510(k) template.
Fixes	None
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None
Enhancements	1. CDRH: Updated internal device code data stores. 2. CDRH: Updated IVD Turbo 510(k) template.
Fixes	None
Enhancements	None
Fixes	CDRH: Fixed internal device code data stores issue with auto update.
Enhancements	None
Fixes	CDRH: Fixed internal device code data stores issue with auto update.
Enhancements	None
Fixes	CDRH: Fixed internal device code data stores issue.
Enhancements	None
Fixes	CDRH: Fixed internal device code data stores issue.
Enhancements	CDRH: Updated internal device code data stores. CDRH: Updated template for Report of Assembly of a Diagnostic X-Ray System.
Fixes	None
Enhancements	None
Fixes	CDRH: Fixed internal device code data stores issue.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	1. CDRH: Updated internal device code data stores. 2. CDRH: Removed Non-In Vitro Diagnostic Device-510(k) template.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	CDRH: Updated MDR data stores to update the NCI (Concept) code value for FDA_CODE 3190. CDRH: Updated MDR template with a minor text change.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CDRH: MedWatch Form 3500A-E3 option (305-Patient/Consumer) removed as it is a retired code.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	None.
Fixes	CDRH: Fixed -GENC Country Code list issue to Radiation Emitting Product submission. CDRH: Removed versions 2.4,2.5,2.5.2 for Radiation Emitting Product submission.
Enhancements	CDRH: Updated Internal device code data stores.
Fixes	None.
Enhancements	CBER: ICSR submission modified to implement GENC county code standards.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None
Enhancements	None
Fixes	CDRH: Fixed Health Effect - Impact Code list issue for MedWatch form 3500A submission.
Enhancements	CDRH: Updated internal device code data stores. CDRH: Updated MedWatch Form 3500A submission. CTP: Updated HD/RD Master Template to add a new header that contains informational text for users who are looking to submit PMTA information.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	CDRH: Fix to save the encoded attachment files details in the XML.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CDRH: emdr Form 510K submission issue.
Fixes	None.
Enhancements	CBER-CVAERS: Updated the ICSR.xml and related java changes
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	ALL: ZIP archives previously unable to be opened in Window's default ZIP software.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	ALL: Added support for GENC-3 country code format for submissions supporting the GENC-3 standard. CDRH: Updated internal device code data stores. CDRH: MedWatch Form 3500A submission modified to implement GENC-3 country code standards. CDRH: Radiation Emitting Product submission modified to implement GENC-3 country code standards. CDRH: 806 Corrections and Removals submission modified to implement GENC-3 country code standards. CDRH: Report of Assembly of a Diagnostic X-Ray System submission modified to implement GENC-3 country code standards.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores. CTP: Tobacco Harmful and Potentially Harmful Constituents Submission Submission Documents updates to allow for BMP, DTD, XSL, MP4, and PNG file attachments CTP Transmittal Form Submission Documents updates to allow for BMP, DTD, XSL, MP4, and PNG file attachments Listing of Ingredients in Tobacco Products Submission Documents updates to allow for BMP, DTD, XSL, MP4, and PNG file attachments Tobacco Health Document / Requested Document Submission Updated business rules to load new versions of HD (V10) and RD (v1.1) sub templates Submission Documents updates to allow for BMP, DTD, XSL, MP4, and PNG file attachments Health Glossary updates to allow for BMP, DTD, XSL, MP4, and PNG file attachments
Fixes	None
Enhancements	CDRH: Updated internal device code data stores.
Fixes	CTP: Updated outdated guidance document link in the Overview node of the following templates: HDRD Master (HEALTH_REQUESTED_DOCS_MASTER.XML) HPHC Form (TOB 904(A)(3) TEMPLATE_V8.xml) TI Form (TOBACCO_INTRO_904_V13.xml)
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None
Enhancements	CDRH: Updated internal device code data stores.
Fixes	CTP: Tobacco Health/Requested Document Submission: Corrected address information on the overview screen.
Enhancements	CTP: Tobacco Health/Requested Document Submission is a new master template available to users to submit a Health Documents (HD) submission or Requested Documents (RD) submission. The correct sub-template (HD or RD) will generate based on data collected from the user. Tobacco Health Document Submission Enhancements  Users will no longer use the CTP: Health Documents Form to create a Health Document submission. The CTP: Tobacco Health/Requested Document Submission template must be used instead. Removed metadata entry on the ‘Tobacco Health Documents’ screen. A new excel spreadsheet template is now available for download where users can enter their document file names and related metadata and attached. Tobacco Requested Document Submission Enhancements  Users will no longer use the CTP: Transmittal Form to create a Requested Document submission. The CTP: Tobacco Health/Requested Document Submission template must be used instead An excel spreadsheet template is now available for download where users can enter their document file names and related metadata and attached.
Fixes	CTP: Earlier versions of HD template and RD template (via CTP: Transmittal Form) will no longer be accepted, and the user will be required to use this new master template to submit an HD or RD submission.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	ALL: Fixed import/export issues related to address book.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores. CTP: CTP Transmittal Form v2.0: Removed “SW” from the dropdown list of submission types CTP Transmittal Form v1.9: Updated allowed creation date and submission date. Last Create Date set to 03/04/2019, and Last Submit Date set to 09/05/2019
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CTP: Health Document Submission: In the 'Country' dropdown field, on U.S. Agent Screen, 'United States' is the only available option. 'State, Province or Territory' is now deleted. Product Ingredient Listing: In the 'Country' dropdown field, on U.S. Agent Screen, 'United States' is the only available option. 'State, Province or Territory' is now deleted. CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CTP: Updated Tobacco Health Document Submission Template Updated Tobacco Product Ingredient Listing Template Updated Listing of Ingredients Import Spreadsheets CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CTP:Updated Submittal Form Template CTP:Updated Ingredients Specification Import Spreadsheets CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	CTP:Updated HD Template to Match Paper Form: Updated Contact Information sections/fields Added two new fields in Health Documents section "Presence of document in the University of California San Francisco Tobacco Truth Documents Library database" and "Document Type." CDRH: Initial release of Quik Review Pilot. CDRH: Updated internal device code data stores.
Fixes	CTP: HC Template – fixed minor issue with XML Property error.
Enhancements	CDRH: Updated internal device code data stores
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores. CDRH - MedWatch 3500A: Decommission of ICSR R1 New 3500A template, version 2.2, includes the removal of all R1 specific fields Update to existing outosb.jar file to accommodate for changes to template Update to Medical Device Reporting codes Device Problem Codes Results Codes Method Codes Conclusion Codes CTP - TI Template Updates:   Updated Instruction Text in the "Data Entry Method" section for "Product and Ingredient Listing" Options A and C Updated "Import_904_Ingredients Specification Update" spreadsheet to version v3a when Submission Type = A, B, C, F and "Products and Ingredients Listing" = B
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores. Updated CDRH 510K and De Novo templates.
Fixes	ALL: Update to auto-updater to resolve proxy support errors.
Enhancements	CDRH: Updated internal device code data stores. Updated CDRH 510K and De Novo templates.
Fixes	None.
Enhancements	None.
Fixes	CTP: Fix to TI template and import spreadsheet.
Enhancements	CTP: Added an FDA created spreadsheet, for Leaf-Wrapped Cigar products. CDRH: Updated Radiological Health templates to display the 36 form burdens from 2017 in support of mandatory information collection reviewed by the Office of Management and Budget (OMB).
Fixes	None.
Enhancements	None.
Fixes	CTP: Updated the E-Liquid spreadsheet to the .xlsx format ignore warnings that describe possible file type conversion.
Enhancements	CDRH: Updated internal device code data stores. CDRH: Report of Assembly of a Diagnostic X-Ray System template updated: Updated expiration date on the Introduction Page (text change) Updated Document Mail Center Room # on the Introduction Page (text change) CTP: Updated TI template and spreadsheets: Added method for users to submit their own spreadsheets Updated FDA-created spreadsheets section to include a spreadsheet specifically for e-liquid products and a spreadsheet for any product type Updated Product Listing and Ingredient Listing information sections to dynamically change the text displayed based on the data input selected
Fixes	None.
Enhancements	None.
Fixes	CTP: Removed watermarks from the FDA-created product spreadsheet and removed "E-Liquids only" from the description.
Enhancements	CDRH: Updated internal device code data stores. Updated documentation, including: Quick Guide, Digital Signature Guide, and FAQ
Fixes	Address questions incorrectly default to "US" even if no data entered in address fields.
Enhancements	ALL: Increased the memory limit within "File" > "Preferences" menu, the upper limit is now 5GB. CDRH: Updated internal device code data stores. CTP: Multiple updates to templates and additional data import spreadsheet: Added question to ask users for the method used for entering product, component, and ingredient information. Modified instructional and informative text based on method of entry. Added a spreadsheet for importing e-liquid product information.
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores. CTP: Multiple updates to templates and additional data import spreadsheet: Added question to ask users for the method used for entering product, component, and ingredient information. Modified instructional and informative text based on method of entry. Added a spreadsheet for importing e-liquid product information
Fixes	None.
Enhancements	CDRH: Updated internal device code data stores.
Fixes	None.
Enhancements	1. CTP: Updated submission templates to allow Excel (XLSX) file attachments. 2. CDRH: Added the OMB number and expiration date to the submission type description on the "Create New Submission" dialog.
Fixes	CTP: To maintain consistency with the eSubmitter application, the “Co-Package” question on the Import spreadsheet has been marked as required.
Enhancements	None.
Fixes	CTP: Updated TI template to correct maximum file size of submission batch files.
Enhancements	None.
Fixes	CTP: Updated TI template to allow for letters and numbers for the FDA-Assigned Tracking Number (TP Number)
Enhancements	CDRH: Removed "NI" (No Information) radio button from Section H of MedWatch 3500A. CDRH: Updated the form expiration date of (806) Corrections and Removals. CTP: Enhanced CTP templates to provide ability to attach .csv and .txt files Enabled file validation in CTP templates to show error message when files with unsupported characters are attached
Fixes	None.
Enhancements	ONADE: The Blood Level Bioequivalence Protocol QbR template Pilot has been completed, the template has been updated to reflect comments received during the Pilot period.
Fixes	ONADE: Removed the "Are you submitting a labeling supplement that qualifies for a 60 day review (21 CFR 514.8(c)(2)(I)(A) or (D)?" question from A-C/R-NF submission types since it is not applicable for an ANADA application.   ONADE: Fixed an issue where the Purpose of Submission was not being generated for A-B-AR submission types.
Enhancements	CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	None.
Enhancements	CTP: Template enhancements including:   Require 'parent' TI STN for option "f" in Submission Type selection Accept additional file extensions, specifically .csv and .txt Turn on 'file validation' to display error for unsupported characters in file names
Fixes	CTP: Following issues have been fixed:   Leaf Tobacco option missing from the Dropdown for option "f" in Submission Type selection. State/Province fix for Authorized Representative outside United States
Enhancements	None.
Fixes	CDRH: Fixed issue in generated contents of the MedWatch 3500A submission package.
Enhancements	CVM OSC DERS: Initial release of CVM: OSC DER SUBMISSIONS templates, which include CVM post-market semi-annual, annual, and special Drug Experience Reports (DERs) submission types. These submissions are submitted to the Office of Surveillance and Compliance (OSC). CVM OSC DERS: Updated the Quick Guide to list the availability of post-market OSC DER submission types and provide digital signature instructions related to these submissions. CVM OSC DERS: Updated the User Manual to provide digital signature instructions related to OSC DER submissions. CDRH: Updated fields on screen Consignee(s) Information and associated spreadsheet for importing consignee data. CDRH: Added new fields and business rules to the MedWatch 3500A form. Additions include: New section C for Suspect Products New Race and Ethnicity fields in Section A Updated field description in Section D11 Enabled Pre-1938 and OTC Product Checkbox in Section G5 Enabled Adverse Events Term Section G8 Section D11 increase in characters allowed, now accommodates 500 characters Added business rules validation for new sections and fields
Fixes	None.
Enhancements	CVM ONADE: Added support for multiple file attachments within the 3.0 Claim of Categorical Exclusion section of the Environmental P/NV template. CVM ONADE: Added support for linking documents within G-OT submissions. CVM ONADE: Added an explanatory message, as well as support for collecting Degree information within the US Agent, Responsible official, and Submitter contact Information. CVM ONADE: Added support for collecting additional Early Information details within I-H-SP submissions.
Fixes	CVM ONADE: Fixed an issue where original submissions for all document types were not properly displaying when no currently established file or application was provided. CVM ONADE: Removed a duplicate required question from the product description screen of the N-E-OT submission type.
Enhancements	None.
Fixes	ALL: Fixed handling of tabular data relationships. Relationships previously relied on correct sequencing of records within submission data files and could become corrupted if records became unsequenced. Handling of relationship data is improved and no longer has a dependency on record sequences.
Enhancements	CVM ONADE: Adjusted the Early Information (EI) message text within INAD submissions to better clarify the intent
Fixes	None.
Enhancements	CDRH eCopy: Standardized validations across eCopies template to align with validations performed by eCopies Loader and validator tool
Fixes	None.
Enhancements	None.
Fixes	CVM ONADE: Fixed an issue within the Original NADA submission type where the Amendment section was not being properly displayed.
Enhancements	None
Fixes	CVM ONADE: Fixed an issue within General Correspondence submission types where the Other; Unclassified (OT) section was not being displayed properly.
Enhancements	CDRH: To support the reorganization of districts into divisions the district dropdown was replaced with radio buttons for each division.
Fixes	None
Enhancements	CVM ONADE: Adjusted the Chemistry, Manufacturing and Controls (MC) section for INAD and JINAD Major Technical Section (P) submissions by refining the outline and question structure, while also fixing issues related to incorrectly identified missing data.
Fixes	CVM ONADE: Added additional document types when submitting an Administrative Request (AD) to change the Responsible Official/U.S. Agent. CVM ONADE: Adjusted the foreign visitor status question to be hidden within the Firm Participants screen when no foreign visitors have been designated to be included to avoid potential confusion when the response is blank within the report output.
Enhancements	CDRH: Added character validation to limit characters allowed in file names.
Fixes	CDRH: Address text updated throughout template. Text "G0609" updated to "G609"
Enhancements	None.
Fixes	CVM: Fixed an issue within the General Correspondence/Request for Meeting submission type where the meeting information section was not being displayed properly.
Enhancements	All: Replaced the "Address Book" and "Contact Book" with a new consolidated address book. The consolidated address book provides the following features:   Existing address book entries and contact book entries have been moved to the consolidated address book. One location for managing establishments/organizations and contacts. Contacts are maintained under affiliated establishments/organizations. An Organization/Contact view for managing contacts affiliated with each organization. A Contact only view for managing and selecting individual contacts.
Fixes	None.
Enhancements	None.
Fixes	CVM: Fixed an issue within the General Correspondence/Final Printed Labeling submission type where the Final Printed Labeling section was not being displayed properly.
Enhancements	CVM: Fixed a typo within the 3.0 Claim of Categorical Exclusion section of the Environmental P/NV template. CVM: Increased the response length of the Protocol Title question from 250 to 500 characters within the Bioequivalence Protocol E/BQ template. CVM: Added ability to submit Administrative Requests (AD) as a Supplement (C) to an ANADA/NADA.
Fixes	None.
Enhancements	CVM: Updated the OMB number expiration dates within the Document Information sections. CVM: Added eXtensible Markup Language(XML) and SAS XPORT (XPT) file attachment support to questions within P/NV, X/CE, and X/EA templates.
Fixes	CTP: Tobacco Product Ingredient Listing – Resolved display of incorrect component type options following import of products from spreadsheet.
Enhancements	None.
Fixes	CBER eVAERS: Corrected the country code standards used for reporter information to use ISO 3166-1.
Enhancements	CBER eVAERS: Adjusted the minimum acceptance criteria for the Patient's Date of Birth question to year and month. CVM: P/NV templates: Modified the wording of the categorical exclusion citations on Screen 3.0 to reflect the wording in the regulations. Modified or added instructions on Screen 3.0 for clarity. Consolidated sub-screens 3.1 through 3.7 into Screen 3.0. Consolidated screens 4.0 and 4.1 and screens 5.0 and 5.1, and removed unnecessary questions on these screens. Modified the wording of the questions on Screen 1.1, Reference Listed New Animal Drug. CVM: J/X/CE templates: added Screen 1.1, Reference Listed New Animal Drug. CVM: I/X/EA template: removed unnecessary questions on Screen 3.0.
Fixes	None.
Enhancements	CVM ONADE: Adjusted the designation status question text and hint within product description screens to include minor use/minor species (MUMS) text for improved clarity.
Fixes	CTP: Corrected discrepancy between Tobacco Product Ingredient Listing template and import spreadsheets for "Quality – Unit of Measure" field.
Enhancements	1. CTP: Tobacco Product Ingredient Listing – Released a new version of the TI template (v2.0) to allow for data entry of newly deemed products as well as their component, ingredient, and identical product information. This version also contains updates to the Submission Type, Identification Information, and Confirmation screens to comply with the updated paper form (FDA 3742). 2. CVM ONADE: JINAD Blood level bioequivalence protocol (E) template updated to question-based format. 3. CVM ONADE: Added support for identifying foreign attendee participation within meeting requests (Z).
Fixes	CVM ONADE: Corrected label identifier references for Veterinary Feed Directive (VFD) within associated templates.
Enhancements	CVM: Amendment template now supports the functionality of allowing a sponsor to change the responsible official.
Fixes	None.
Enhancements	CDRH: Release of new template 806 Corrections and Removal Reporting to support reporting of medical device corrections and removals to the Center for Devices and Radiological Health (CDRH) as outlined by 21 CFR 806
Fixes	CDRH: Corrected spelling errors in template text.
Enhancements	None.
Fixes	CBER eVAERS: Fixed an issue where Reaction(s)/Event(s) resulting in death prevented submission packaging.
Enhancements	CVM: Patent Question Modified in the following Templates : NADA A-OT, E-OT, C-B1 and R-B1.
Fixes	None.
Enhancements	None.
Fixes	CBER eVAERS: Fixed an issue where structured medical history was required when none may be available.
Enhancements	CBER eVAERS: Various template and output message changes:   Reaction(s)/Event(s) section changes (i.e., new Caused/Prolonged Hospitalization rules). Drug Information section changes (i.e., the first product listed in the drug information section must be a vaccine and characterized as Suspect or interacting). Drug/Dosage section changes (i.e., moving the collection of the regional vaccination facility and associated healthcare professional to a separate section). Patient Demographics and Characteristics section changes (i.e., added "NI" null flavor to patient ethnicity). Relevant Medical History Patient and Parent section changes (i.e., allowing support for both structured and unstructured data). Application Number for non-vaccine products to be reported with NDA/ANDA prefix when available for US reports.
Fixes	CBER eVAERS: Fixed an issue within the output of the Parent Route of Administration section of the Drug Dosage information. CDRH: The Rad Health laser product report template was updated in several sections of the Technical Data tab to remove an improper "Required" status of some questions and to modify a couple of other questions to permit text entry rather than just numeric entry.
Enhancements	None.
Fixes	CVM: Fixed an issue where users were unable to attach Package Insert "other labeling" when using the A-E-OT eSubmitter template.
Enhancements	CVM: All OSC DAF templates that have a Species Class node will now have the use level listed by class, not just species. Different classes within a species can now have different use levels. CVM: eSubmitter amendment templates no longer contain the selection of End Review Amendment for the following submission types: INAD: P, E NADA: A, E CVM: Minor textual change were made in the following templates: NADA-A-OT: Nodes 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7 NADA-C-B1: Nodes 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7 ANADA-A-OT: 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9 ANADA-C-B1: 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8 CTP: All Templates - Added informational message for users to ensure they are using the most recent version of eSubmitter and not blocking automatic eSubmitter updates. Also added information to the packaging screens to introduce the new CTP Portal. CTP: ESG Transmittal Form - Changed the name of the template to CTP: Transmittal Form. CDRH: eCopy - Included additional invalid character support checks for file names. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	None.
Enhancements	CVM: Released new template to enable the animal drug industry to voluntarily submit submissions to a Minor species Index File System (MIFS) electronically. Production Deployment July 1st, 2016. CDRH: Deactivated the ISO-13485 template on 7/1/2016 from production since the program ended and the grace period has expired. CDRH: Updated the Medical Device eCopy template to include an introductory page with guidance information on the program. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	None.
Enhancements	CBER VAERS: Changed the drug application number to only support a BLA number. CBER VAERS: Changed all occurrences of MPID to require NDC formatted data entry when provided for US reports. CBER VAERS: Changed the output message for phone, fax, and email to include an additional telecommunications type when a null flavor is provided.
Fixes	None.
Enhancements	None.
Fixes	CDRH: Fixed an issue within the PDF MedWatch report output where the narrative text in section H10 was not being included.
Enhancements	CVM: Implementation of established name change along with HFV-180 division change. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	None.
Enhancements	CBER VAERS: Changed the form title to better reflect that only eVAERS submissions are currently supported. CBER VAERS: Changed the email support links to reference the CBER ICSR Submissions help desk. CBER VAERS: Adjusted the Patient State to support null flavor for US reports. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	None.
Enhancements	CVM: Implementation of the B1 Generic question for MCSR in ANADA submissions.
Fixes	None.
Enhancements	None.
Fixes	CBER VAERS: Fixed an issue related to a few international country codes not being converted correctly within the output message.
Enhancements	CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	All: Fixed an issue where the re-ordering of rows within tabular screens could result in concatenated information. All: Fixed an issue where a Manifest creation error was resulting for some users due to rights issues related to where the Manifest file was being created. All: Fixed an issue where the Trade Mark symbol could no longer be included within textual responses. CVM: Fixed an issue where the report output did not always include all screen sections for a specific submission type.
Enhancements	CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	None.
Enhancements	All: Updated the country list. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	CBER VAERS: Fixed an issue where improperly structured MPID data was allowed during data entry that would not pass validation when received at FDA.
Enhancements	CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	None.
Enhancements	CVM OSC DAF: Questions removed from IFA Notice of Shipment template. CVM OSC DAF: Section added to and wording for questions changed for IFA Firm's Slaughter Notice template nodes 3.0 - 3.3. CVM OSC DAF: Confirmation pop-up removed from Core Questions amendment question, and hint text modified for Document Information question. CVM OSC DAF: Text change for questions in IFA Notice of Shipment template screens 2.0 and 4.0. CVM OSC DAF: Hint text modified for Core Questions IFA submission Document Information question. CVM OSC DAF: Added hint to withdrawal period question on screen 5.0 for IFA Firm's Slaughter Notice template. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	CVM ONADE: Chemistry Supplement Reactivation - Prior Approval template informational message text change. CVM ONADE: Users can now attach multiple VFD Statement Files when submitting Animal Feed Labeling. CVM ONADE: Chemistry, Manufacturing and Controls template Module 3 is now optional when "Feed Method Trial Study with Data Only" option is selected. CVM ONADE: Cross-node relationships have been added to nodes 2.3.S Drug Substance to 2.3.S.7 Stability to allow entry for multiple Active Ingredients on Chemistry, Manufacturing and Controls template. CBER VAERS: Adjusted the primary source rule requiring either a first or last name so that it only impacts US source reports. CBER VAERS: Adjusted the patient country to support MSK an NI null flavors when NOT a US report.
Enhancements	CBER VAERS: Added the following three, more generic options, to the 'Vaccine Anatomical Approach Site' question: Arm, Thigh, and Buttock to support conditions when more specific Left or Right information is not available.
Fixes	None.
Enhancements	CBER VAERS: Added the null flavor options: UNK, ASKU, and NI to the 'Vaccine Anatomical Approach Site' question within the 'Vaccines Given Within Four Weeks' section.
Fixes	None.
Enhancements	All: Added restrictions to the name of the submission file when created by the user to only allow English characters (A-Z, a-z), digits, underscores, dashes, and parenthesis. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	CBER VAERS: Fixed rules regarding Patient Age and Reaction/Event Dates and Duration that were not correctly supporting null flavor values. CBER VAERS: Fixed response length and numeric type formatting across questions, as needed. CBER VAERS: Removed the TRICARE Beneficiary option and added null flavor support to the Patient's Military Status. CBER VAERS: Fixed an issue where the Email Address for the Healthcare Professional/Best Contact was not outputting in the generated message. CBER VAERS: Adjusted UCUM values (Trimester, Decade) to output in lowercase within the generated message. CBER VAERS: Fixed an issue where Treatment Facility responses were not properly disabled when switching to 'None of the Above' within Seriousness Criteria of the Event.
Enhancements	CBER VAERS: Adjusted the dosage effective time to require at least one of the response types (i.e., start time, end time, duration). CDRH: Added file path/name restrictions to Radiation Emitting Product submissions to limit the characters allowed to english alphanumeric characters, underscores, dashes, parenthesis, and spaces. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	CBER VAERS: Adjusted the MSK null flavor rule for primary source reporters. The null flavor MSK within the primary source reporter section is only allowed for non-US reports based on the country address for the primary source reporter for regulatory purposes (ICH C.2.r.5). Initially, the rule was applied to all primary source reporters; however, per VAERS program requirements, MSK is only not allowed for US reports for the source associated with ICH C.2.r.5. CBER VAERS: Fixed an issue where free text only responses for dosage form, route of admin., and parent route of admin. were not being included within the generated output message.
Enhancements	None.
Fixes	CVM: Fixed an issue preventing completion and submission of an Original General Correspondence document.
Enhancements	CVM: Templates added for Office of Surveillance and Compliance (OSC) Division of Animal Feeds (DAF): Food Additive Petition (FAP) Original FAP Reactivation of Original General Correspondence Protocol - No Data Protocol - Data Firm's Request for Changes to CVM's MOC Request for Meeting Investigational Food Additive (IFA) Initial IFA Notice of Shipment Amended Food Use Authorization Protocol - No Data Protocol - Data General Correspondence Original Food Use Authorization Data Submission Firm's Slaughter Notice Firm's Final Disposition Firm's Request for Changes to CVM's MOC Request for Meeting GRAS Notice Initial Submission General Correspondence Original Notification Firm's Request for Changes to CVM's MOC Request for Meeting CDRH: Removed the 510(k) pilot template as the pilot period has ended. CDRH: Added new items to the product code class filter to further delineate between class options. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	None
Enhancements	None.
Fixes	CVM: Fixed an issue related to the submission report recieved by FDA
Enhancements	None.
Fixes	CBER VAERS: Fixed an issue within the output message where an indication for use as reported by the primary source was provided in text form without a corresponding MedDRA code.
Enhancements	None.
Fixes	CVM: Fix to (J)INAD Chemistry, Manufacturing and Controls template to: Restore the functionality to enable nodes 2.3.S & 2.3.P when appropriate selections are made. Restore the functionality to disable all nodes between 1.0 and 5.0 when “Abbreviated Response” is selected on node 1.0.
Enhancements	CDRH: Updated the eMDR lookup tables to remove inactive codes.
Fixes	None.
Enhancements	CDRH: Adjusted template to reflect latest eMDR changes.
Fixes	None.
Enhancements	CVM: Chemistry, Manufacturing, and Controls template changes including: The list builder question remains disabled and not required after the user selects "No" as a response to "Are there any additional CVM Submission Numbers associated with your CVM Technical Section Incomplete Letter(s)?". The CMC Sections question is always required. CVM: Core Questions template changes including: HFV-100 added to the list of values for G submission types. CBER VAERS: Adjusted the business logic associated with patient age information. Age Group is now required entry when no other age related information is available. However, Age Group supports null-flavors (ASKU, MSK, NI, UNK) when absolutely no age related information is available. CBER VAERS: Patient and Soure Reporter County is automatically output as the null-flavor "NI" for non-US reports. CBER VAERS: Patient and Soure Reporter State/Province now includes the null-flavor option of "NI" for non-US reports. CBER VAERS: Parent sex is now required entry when a parent is included within a report.
Fixes	CBER VAERS: Vaccination Facility Military Status has been corrected to now support "false" as an option for the output.
Enhancements	None.
Fixes	CDRH: Fixed an issue with the patient and device problem code lists. CDRH: Fixed an issue where the "Other Number" response from section D was missing from the output file.
Enhancements	CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	CBER VAERS: Adjusted the language codes to properly reflect the ISO 639-2 data standard.
Enhancements	CBER VAERS: Adjusted the limit for adding associated persons so that only one parent can be added for VAERS reporting. CBER VAERS: Adjusted the patient drug history section so that one drug history item is required, the name of the drug should be set to "NA" if no drug history information is available.
Fixes	Fixed an issue related to the table question losing data when a submission is reopened.
Enhancements	Released CBER Individual Case Safety Reports (ICSR) to Production.
Fixes	Fixed an issue where some users were incorrectly receiving validation errors resulting from valid phone entry.
Enhancements	None.
Fixes	CVM: Fixed an issue in the I/P/NV eSubmitter template preventing sponsors from being able to submit when they are requesting a Categorical Exclusion. CVM: Fixed an issues in the N/B/CA and A/B/CA templates pertaining to missing questions.
Enhancements	Added support under preferences for identifying where contact/address book information is stored. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	CBER VAERS Pilot: Removed the redundant folder from the output, now the output message will be saved directly to the package folder. CBER VAERS Pilot: Revised the Testing Result data entry section to better support singular and range values. CBER VAERS Pilot: Adjusted UCUM selection lists and numeric representations (integer/decimal), as needed. CBER VAERS Pilot: Added missing codes to the Facility Type list. CBER VAERS Pilot: Removed duplicates from the Language selection list. CBER VAERS Pilot: Refined the validation checks on the MedDRA version number to ensure proper formatting. CBER VAERS Pilot: Adjusted the Vaccination Military Status to support Yes, No, and No Information. CBER VAERS Pilot: Added Code System data entry to Dose Form, Route of Admin, and Parent Route of Admin when entering a term that is not part of the SPL code set. CBER VAERS Pilot: Fixed an issue where the Name of the Drug Provided was not properly outputting NA as a null flavor. CBER VAERS Pilot: Added a hint to MPID Version/Date entry to reflect the proper format of the data to be provided.
Enhancements	None.
Fixes	CVM: Fixed an issue within the generated submission package where the purpose of submission was not set correctly for Z and Y Submission Types (A/Z/OM, A/Y/OM, G/Z/OM, G/Y/OM, I/Z/OM, I/Y/OM, J/Z/OM, J/Y/OM, N/Z/OM, N/Y/OM, V/Z/OM, V/Y/OM).
Enhancements	None.
Fixes	CVM: Fixed an issue with the I/J-P-MC templates that was preventing access to Module 3 information. CDER/CBER GDUFA Generic Facility Self-Identification template: Fixed an issue related to Business Operations and non-generics.
Enhancements	CTP: Users will no longer have the ability to attach zip files in any of the submissions. CBER: Inactivated the Investigational New Drug (IND) Application, including Antivenin INDs, eCTD Structured template. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	CBER VAERS Pilot: Fixed an issue where the drug application number was incorrectly being output when no user response was provided.
Enhancements	None.
Fixes	CVM: Updated eSubmitter to create a new Submission Classification Code (OM-ONADE Meeting). Removed PS and OO as sub class codes. Added a radio button selection to all the Z templates to allow for the selection of either Pre-submission conference (PS) or ONADE Other (OO) meeting. CVM: Updated the INAD A-0000, INAD - Z, GC-A-0000 and GC-Z Templates to include questions pertaining to the submission of early information. CVM: Added a new team to all the meeting request (Z) templates: Team 4 Canine, Feline and Wildlife (HFV-118). CVM: Updated the (J)INAD templates to change the business rules to collect only one referenced submission. CVM: Updated the (J)INAD B-OT, J/INAD-P-NV, and J/INAD-X templates. CVM: Deactivated the VMF-P-OT Template. CVM: Updated (A)NADA R-CS, AS Templates to add a message instructing sponsors that might be trying to respond to a Prior Approval Supplement incomplete letter as a CBE30. CBER VAERS Pilot: Adjusted available nullflavor responses within Patient/Parent Race and Vaccination Facility Type. CBER VAERS Pilot: Adjusted the Dose number Unit to properly support "{DF}". CBER VAERS Pilot: Fixed an issue where the Primary Source was not outputting the County Code when identified as the Patient. CBER VAERS Pilot: Fixed an issue where the Vaccination Facility Military Status was not properly converting a "No" response to "NI" in the output. CBER VAERS Pilot: Adjusted the OID used when outputting the FDA Specialized Product Types. Fixed an issue where responses to tabular questions could not be deleted without adding a new response.
Enhancements	CBER: Added support for multiple codes of "Illness at Time of Vaccination" within the VAERS Pilot template.
Fixes	CDER/CBER: Fixed an issue with Generic Drug Facility Electronic Self-Identification submission type output related to international phone numbers.
Enhancements	CBER: Released an updated CBER VAERS template and output capability for VAERS Pilot Participants. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	None.
Enhancements	None.
Fixes	Fixed an issues related to the CDRH 510(k) template and international phone/fax numbers preventing the output from generating.
Enhancements	CTP: Updated the Ingredient Listing, Health Documents, Harmful and Potentially Harmful Constituents and the ESG Transmittal Form to collect a cover letter in a separate attachment question. Updated question text on existing attachment question and separated the Comments section to stand alone. Added a message to inform users of the changes. Enhanced the HTML Submission Report output to include Expand/Collapse capabilities within section headers. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	Fixed a header formatting issue within the Adobe PDF version of the Submission Report.
Enhancements	CBER: Updated the eSubmitter Electronic Participant Checklist to reflect new DCC mailing address. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	CTP: Fixed an issue within the HPHC template where 'Other' text for mexthod of separation and detection were not properly being saved. CDRH: Fixed an issue within the Report of Assembly of a Diagnostic X-Ray System submission so that a zip code extension is no longer required within the data entry.
Enhancements	CDRH 510(k): Adjusted the list of available file types that can be attached within a submission (e.g., removed support for Microsoft Word .docx files). CDRH 510(k): Adjusted text within the template and eSubmitter to reflect the end of the CDRH 510(k) pilot. Going forward, only applicants that have already submitted submissions can continue to submit documentation via this eSubmitter template.
Fixes	None.
Enhancements	CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	None.
Enhancements	None.
Fixes	CVM: Fixed an issue where eSubmitter submissions greater than 2 GB cause the ESS Mediator to "Hang" or become nonresponsive thus not processing the submission and making it available for review. Developed a viable solution to accommodate eSubmitter submissions that are up to 10 GB in size.
Enhancements	CBER: Added new approach to supporting Null Flavor capabilities within the ICSR template.
Fixes	None.
Enhancements	None.
Fixes	CVM: Fixed the issue preventing the activation of Node 5.0 in the INAD P-MC, JINAD P-MC, and ANADA A-OT templates.
Enhancements	CVM: Two modifications were made to both the I-P-NV and J-P-NV templates: 1) permit both PDF and XML files to be attached to Node 6.0 and 2) change the need for a file attachment from required to optional for Nodes 3.1, 3.3, 3.4, and 3.5. CBER: General updates to the ICSR template and HL7 output message.
Fixes	None.
Enhancements	CVM: Implemented 1 GB submission file size limit. All submissions greater than 1 GB will be broken into multiple files that are less than 1 GB in size. Each ZIP file must be submitted separately through the ESG to complete the submission. Once all submission "pieces" are received, one CVM ESS receipt will be issued. CVM: Allow the sponsor to attach the pharmaceutical development report as a PDF document in the following templates, J-P-MC, I-P-MC, A-A-OT. CVM: Added a hint to Section 2.3.P.4.d, on the Excipient Manufacturer Details tab in the following templates J-P-MC, I-P-MC, A-A-OT. CVM: Updated Chemistry Manufacturing and Controls technical section templates (I/P/MC and J/P/MC) and the A-A-OT template to permit identification of whether the sponsor is submitting a two phased submission. CVM: Deleted the question in Section 2.3.P.3.a, "What are the quality standards for each component used in the manufacturing process?" in the following templates, J-P-MC, I-P-MC, A-A-OT, A-E-OT.
Fixes	An issue within the FDA production webserver that prevented downloads of the previous eSubmitter updates has been resolved.
Enhancements	CDRH 510(k): Added a question in Patient Contact Materials that request color additive information. This question is necessary according to the RTA Guidance document. CDRH 510(k): Added ability to add Preamendment, Exempt, down-classified PMA, and De Novo submissions as predicates. CDRH 510(k): Removed listing of the predicates as Related Submissions, they will be obtained separately within the SE Comparison section. CDRH 510(k): The user may now choose to have the 510(k) Summary be produced automatically, using data entered throughout the template. The data used to produce the 510(k) Summary are clearly distinguished and advise in prominent text to not include confidential information in these sections, since the 510(k) Summary is made public if the submission is found SE.
Fixes	Fixed a report output and packaging issue involving international phone numbers.
Enhancements	CBER: General updates to the ICSR template and HL7 output message. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	CDRH and CBER: Fixed an issue where dates earlier than 1950 were no longer supported (related to ICSR submission types).
Enhancements	CBER: Added support to enforce that Reaction/Event matrix items are always associated to an existing Drug and Reaction within the ICSR template and HL7 output message. CBER: Added support for partial dates within the ICSR template and HL7 output message. CBER: General updates to the ICSR template and HL7 output message. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	None.
Enhancements	CBER: Updates to the ICSR template and HL7 output message. CDRH: Added the OMB control number to ISO13485 template, The OMB control number is 0910-0700 and expires February 28, 2015. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	None.
Enhancements	CVM: An administrative indicator was added to the following templates to address the AGDUFA II modifications: ANADA Supplement (A/C/B1), NADA Supplement (N/C/B1), and ANADA Original (A/A/OT). CBER: Added product correspondence as a type of submission in Whole Blood and Blood Components submissions. CDRH: Added a rule to the CDRH 510K submission type to ensure Other Regulations cannot contain a Class III product code unless also designated within the Primary Regulation. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	CBER: Fixed the font size issue with the Whole Blood and Blood Components PDF submission report output.
Enhancements	None.
Fixes	CVM: The following templates were rolled back to the last version to the 6/13/14 release: ANADA Supplement (A/C/NF) and NADA Supplement (N/C/NF), to remove the ADUFA III specific questions that will not be available until 10/1/14.
Enhancements	CBER: Released CBER Individual Case Safety Reports (ICSR) to Production for VAERS Pilot Participants. CBER: Updated the BLA submission mailing address and included an updated CBER eSubmitter Participant Checklist. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	CDRH: Fixed an issue where standards did not always properly maintain the selected organization and year references.
Enhancements	CVM: In reauthorizing the Animal Generic Drug User Fee Act of 2013 and the Animal Drug User Fee Act of 2013, the FDA committed to provide enhancements to its review environment that include substantive changes to the Center for Veterinary Medicine's (CVM) Submission and Review System. The enhancements that were agreed to in this reauthorization are outlined in the Goals Letter. This release will update the following templates for the Office of New Animal Drug Evaluation (ONADE). Templates impacted by modifications for AGDUFA II: A-E-OT, A-C-CS, J-P-BQ, J-P-HF, J-P-MC, J-P-NV, J-P-PE Templates impacted by modifications for ADUFA III: A-C-AS, A-C-B1, N-A-OT, N-C-B1, N-C-CS
Fixes	None.
Enhancements	CTP: Adjusted the CTP Document Control Center mailing address within the packaging dialog to reflect the new address for mailing CD submissions. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	CDRH: Fixed an issue within the MedWatch submission output that didn't properly differentiate between the manufacturer contact and site (i.e., G1 and G2) when site information was available but no contact information was provided. CDRH: Fixed an issue within eCopies to remove certain special characters (e.g., pound, tilde, single quote) from file names before generating the submission output.
Enhancements	CDRH: Released new electronic Premarket Notification 510(k) Pilot template. CDRH: Adjusted the eCopies template to use a simpler file attachment approach. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	CVM: Fixed an issue where international phone numbers were formatted incorrectly within the HTML report output.
Enhancements	None.
Fixes	CVM: Fixed an issue where data was lost when updating the Document Number.
Enhancements	CDRH: Updated the OMB form expiration date to January 31, 2017. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	CTP: Fixed an issue where numbers being imported from a spreadsheet within a tabular node were failing to import properly due to extra spaces appearing before or after the numbers in the spreadsheet cell. Fixed an issue where when switching between views (i.e., Simple and Expert) sometimes the contents of the current data entry would become cut-off from the bottom of the screen. This only occurred when the screen was long enough to require vertical scrolling.
Enhancements	None.
Fixes	CVM: Core Questions template version 1.11 reflects updates to the Welcome Screen upon opening a submission. The new welcome screen displays the OMB Number expiration dates with an expiration end date of 2016. The CVM address line 1 has also been updated to reflect a corrected mailing address number. This change applies to all ONADE submissions.
Enhancements	None.
Fixes	CVM: Business Rules have been added to eSubmitter for the following submission types to show Reference Listed Product enabled and required: A-C-AC, A-C-CC, A-C-NL, A-C-NF, A-R-AC, A-R-CC, A-R-NL, A-R-NF, A-R-B1.
Enhancements	CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	CVM: The following templates were rolled back to the last version prior to the 9/12/13 release: INAD Major Technical Section (I-P-MC), JINAD Major Technical Section (J-P-MC), and ANADA Original (A-A-OT). As a result of the 9/12/13 release, questions become disabled (grayed out) preventing required information to be entered. The errors were introduced with the "two phased data submission" questions that were added to these templates. These questions will be added back to the templates in a future release.
Enhancements	CTP: Updated the quantity fields in the CTP’s HPHC and Ingredient templates and import spreadsheets to allow for greater flexibility in data entry. CVM: Added HFV-160 to the LOV for Review Division on the Submission Type tab for all INAD H submissions. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	CTP: Fixed an import issue on the HPHC template that was dropping the last picklist value upon import.
Enhancements	All: Added new keyboard navigation support so that longer screens will auto-scroll vertically when tabbing through questions with the keyboard. All: Added new keyboard short-cut support to table screens (see the new Table option in the main menu for details). All: Added new keyboard outline support for navigating directly to a parent node (Ctrl->M). CDRH: Removed the password and embedded attachment validation from eCopies submissions. CDRH: Minor updates to the RadHealth templates. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	CTP: Fixed an HPHC template issue related to Benzo[a]preen and Benzene and Smokeless products. CTP: Fixed an issue related the import of large numbers being converted to exponential notation.
Enhancements	CVM: Additional question added to the I/P/MC, J/P/MC, and A/A/OT templates to support two phased CMC submissions. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	None.
Enhancements	None.
Fixes	CTP: The CTP ESG Transmittal form’s list of submission types was updated. CBER: Minor update to the Investigational New Drug (IND) Application template.
Enhancements	CVM: OMUMS submissions (I, L, N) are now active and are directed to the appropriate review division. CVM: Minor hint updates to Core Questions. CVM: Additional questions added for J/P/HF and I/P/HF. CTP: Added a new field to CTP’s ESG Transmittal Form which allows Industry to specify their submission type. CTP: Updated the CTP’s HPHC Import Spreadsheets to include an edition date. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	None.
Enhancements	CBER: Released CBER’s Investigational New Drug (IND) Application, including Antivenin INDs, in eCTD Structured Format. CDRH: Updated FDA Form Numbers in RadHealth templates. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	Updated CTP’s User Support phone number in all production templates.
Enhancements	None.
Fixes	CVM: Fixed minor issue with N-C-NL template.
Enhancements	CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	CVM: Minor updates to the following ONADE templates: Core Questions, Original ANADA (A/A/OT), Study Template (MC), Chemistry Report (B/F), Supplement (C), Reactivation of Supplement (R), Protocol (BQ), and Supporting Information (H).
Enhancements	CDRH: Updated the Paperwork Reduction act statement in the Radhealth product report template. CDRH: Updated product code, guidance, and standards lookup tables.
Fixes	CTP: Fixed an issues related to missing data and the Tobacco Registration and Listing and Product Ingredient Listing submission types. CDRH: Fixed an issue where contact/establishment addresses required a state/province/territory for international addresses when it should no longer be required.