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ESG Appendix I: Digital Signatures

ESG User Guide - Table of Contents

FDA does not require submission of a paper copy for electronic submissions submitted using the FDA ESG.

FDA forms (e.g., 1571, 356h) and documents require a signature. Accepted signature methods by FDA are:

  • Scanned signatures
  • Digital signatures
  • Flattened digital signatures. A flattened digital signature must include (see example):
    • the printed name of the signer
    • the date and time when the signature was executed
    • the reason for signature

Please use the Adobe Acrobat Self-Sign plug-in to insert your signature on fillable FDA forms.

The FDA cannot hold digital signatures to a higher standard than paper signatures. The FDA will not check the signature on an electronic or paper-based submission unless there is a directed inspection involving that submission. Please maintain the security certificates associated with your digital signatures in case of a directed inspection.

The FDAAs General Counsel (GC) has said that the FDA must be able to determine the origin of a submission in order to implement fully electronic submissions. The PKI (x.509 version 3 class I) certificate employed by the ESG allows the FDA to determine the origin of the submission through the use of a public/private key exchange.

Please use the 1571 (http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083533.pdf) and 356h (http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/ucm082348.pdf) fillable PDF forms with your electronic submissions to CDER and CBER via the ESG.

  • If you do not include these forms with your electronic submissions, CBER and CDER will not be able to leverage their automated loading processes, reducing the process to a manual one. This results in a large increase in the time required by the Centers to make submissions available to our review community.
  • 356h and 1571 Form Field Sizes
    • For documents sent through the ESG for regulatory review, the most important form fields from the FDAAs perspective are the application number and the submission type.
    • The current form fields have the maximum number of characters allowed. If a form field is not large enough, please abbreviate the text in the field. Increasing the size of a form field or otherwise altering a form would require OMB approval.
    • FDA contractors or administrative reviewers read a submissionns cover letter and selected text to determine the nature and content of the submission. FDA-generated data and information is utilized in FDA submission tracking databases.

Consult with an FDA Center representative to determine which signature method is required for each type of submission.

Example of a flattened digital signature:

 

Example of a flattened digital Signature

 

Frequently Asked Questions about Digital Signatures

  1. Q. A question mark (?) appears if I don't use PDF Self-Sign to create a signature. Will the FDA accept such a submission?

    A. Yes. The FDA will not validate a signature during the submission process unless there is a directed inspection of the submission.

  2. Q. What if I can't fit my full text into a form field?

    A. The most important form fields are the application number field and the submission type field.

  3. Q. Because I used a non-public key digital signature, I received an error message during the eCTD validation steps regarding a "secured" PDF file being present within the eCTD. Will my submission still be accepted?

    A. The FDA understands that this can occur and will not reject submissions based on this.

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