CDRH Proposed Guidances for Fiscal Year 2025 (FY2025)

The FDA’s Center for Devices and Radiological Health (CDRH) is sharing lists of guidance documents that 1) we intend to publish in fiscal year 2025 (FY 2025), 2) we intend to develop, and 3) were previously issued as final guidances and we would like to receive feedback about whether they should be revised or withdrawn.

This information is provided in the following lists: 

• The A-list: Identifies the priority guidance documents CDRH intends to publish during FY 2025.
• The B-list: Identifies the guidance documents CDRH intends to publish as resources permit during FY 2025.
• “Under Construction” list: Identifies guidance documents that CDRH intends to develop as resources permit and that are not on the A- or B-list.
• Retrospective review list: Identifies the final guidance documents that were issued in 1985, 1995, 2005, and 2015 that CDRH commits to reviewing to ensure they continue to represent the Agency’s current thinking.

On this page:

• A-list
• B-list
• Under Construction List
• Retrospective review list for 1985, 1995, 2005, and 2015
• How to comment on these guidance lists or a specific guidance
• Related Links

A-List 

Final Guidance Topics

• 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review (revision)
• Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency
• Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff
• Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564
• Laboratory Developed Tests: Enforcement Discretion Policy Regarding Special Controls 
• Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
• Medical Device Shortages - Implementation of Section 506J of the Federal Food, Drug, and Cosmetic Act
• Registration Fee Waiver for Certain Small Businesses Undergoing Financial Hardship 
• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (revision)
• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (revision)
• Validation of Diagnostic Tests for Emerging Pathogens following a Declaration and Determination under Section 564 

Draft Guidance Topics

• Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management Considerations and Pre-market Submission Recommendations
• Enforcement Discretion Policy for Certain Laboratory Developed Tests for Unmet Needs: Frequently Asked Question
• Enforcement Discretion Policy for Premarket and Other Requirements for NIOSH-Approved Air Purifying Respirators
• Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies (revision of Evaluation of Sex-Specific Data in Medical Device Clinical Studies)
• In Vitro Diagnostics: Labeling
• Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) (revision)
• Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations (revision)

B-List 

Final Guidance Topics

• Computer Software Assurance for Production and Quality System Software

Draft Guidance Topics

• Policy for Regulatory Status of Device Software Functions (revision of Policy for Device Software Functions and Mobile Medical Applications)

Under Construction List 

Final Guidance Topics

• Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling (revision)
• Laser-Assisted In Situ Keratomileusis (LASIK) Lasers - Patient Labeling Recommendations
• Patient Preference Information – Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling (revision)
• Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission
• Evidentiary Expectations for 510(k) Implant Devices
• Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions

Draft Guidance Topics

• 3D Printing Medical Devices at the Point of Care
• Clinical Evidence Considerations for Digital Mental Health Treatment Devices, including Computerized Behavioral Therapy Devices
• General/Specific Intended Use (revision)
• Substantial Equivalence with Limitations: 510(k) Devices (revision of "Determination of Intended Use for 510(k) Devices")

Retrospective Review List 

1985 Final Guidances

• Medical Laser Delivery System Interlocks (Laser Notice 34)
• User Instruction Hazard Warnings (Laser Notice 35)
• Walk-In Workstations (Laser Notice 37)

1995 Final Guidances

• Guidance Document For The Preparation of Premarket Notification For Ceramic Ball Hip Systems
• CPG Sec. 300.300 Ineffective Devices – 502(f)(I) Labeling Requirements
• CPG Sec. 300.400 Contamination of Devices Labeled as Sterile
• CPG Sec. 310.100 Pacemaker Reuse
• CPG Sec. 345.100 Condoms; Defects – Criteria for Direct Reference Seizure
• CPG Sec. 345.300 Menstrual Sponges
• CPG Sec. 355.200 Electrical Muscle Stimulators
• CPG Sec. 355.300 Ion Generating Devices
• CPG Sec. 370.100 Cytotoxic Testing for Allergic Diseases
• CPG Sec. 390.425 Records and Reports; Applicability – 21 CFR 1002.1
• CPG Sec. 391.200 Warning Statement in Advertisements for High-Intensity Mercury Vapor Discharge Lamps that are not Self-Extinguishing (21 CFR 1040.30(e)(3))
• CPG Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture, Auricular Stimulation, etc. (CPG 7133.21)
• CPG Sec. 396.400 Policy on Warned on Sunlamp Products
• CPG Sec. 398.200 Hazardous Diagnostic X-ray Systems
• CPG Sec. 398.300 Registration of Assemblers of Diagnostic X-Ray Systems as Device Manufacturers
• Guidance Document for Testing Non-Articulating, ‘Mechanically Locked’, Modular Implant Components
• Guidance on the Content and Organization of a Premarket Notification for a Medical Laser
• CPG Sec 100.900 International Memoranda of Understanding
• Testing Guidance for Male Condoms Made From New Material (Non-Latex)
• Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Exercise Equipment
• Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices*
• Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles
• Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k)
• User Instruction for Medical Products (Laser Notice 44)
• Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities
• All Holders of Approved Variances For Laser Light Shows and Displays (Laser Notice 46)

* When finalized, Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling: Draft Guidance for Industry and Food and Drug Administration Staff (on the Under Construction List) will supersede this guidance

2005 Final Guidances

• Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
• Information for Healthcare Organizations about FDA's "Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) Software"
• CPG Sec. 310.210 Blood Pressure Measurement Devices (Sphygmomanometers) – Accuracy
• CPG Sec. 390.400 Examples of Electronic Products Subject to the Reporting Requirements Under 21 CFR 1000.15(a)
• CPG Sec. 398.100 Definition of General Purpose Radiographic X-Ray System - 21 CFR 1020.30(b)
• CPG Sec. 315.100 Illegal Interstate Commercial Shipment of Dentures (CPG retitled and revised 5/19/2005)
• Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)**
• Medical Devices with Sharps Injury Prevention Features
• Mammography Facility Surveys, Mammography Equipment Evaluations, and Medical Physicist Qualification Requirements under MQSA
• Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Assays
• Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions***
• Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 CFR 1040.30)

** This guidance is being revised and is on the FY 2025 A-list
*** When finalized, Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff will supersede this guidance.

2015 Final Guidances

• Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications
• Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
• Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval
• Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices
• Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices
• Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems
• Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings
• Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices 

How to comment on these guidance lists or a specific guidance

CDRH appreciates comments on any of the guidance documents on the lists by December 10, 2024.

You may submit written comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with docket number FDA-2012-N-1021 for "Notice to Public of Website Location of CDRH Fiscal Year 2025 Proposed Guidance Development.”

Submit electronic comments to www.regulations.gov. Received comments will reside in the docket and, except for those submitted as "Confidential Submissions," will be publicly viewable at www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. For more detailed information on submission of comments, please refer to the document "Notice to Public of Website Location of CDRH Fiscal Year 2025 Proposed Guidance Development " located on www.regulations.gov under docket number FDA-2012-N-1021.

Specifically, CDRH is seeking comments on the relative priority of guidance documents on the A-list and B-list, as well as proposed policy or information for the FDA to consider for inclusion in these guidances. CDRH also welcomes suggestions for new or different guidance documents and the reasons why a guidance on the topic is needed.

For the retrospective review list, CDRH is seeking suggestions about which final guidances should be revised or withdrawn to help inform the retrospective review of existing final guidances. If a recommendation is made to withdraw or request a modification to an existing guidance document, CDRH requests that commenters also include information regarding why the guidance document should be revised or withdrawn and, if applicable, how it should be revised.

CDRH also welcomes any additional feedback for improving the guidance program and the quality of guidance documents. CDRH believes this docket is an important tool for receiving information from interested parties and for making information available to the public. The feedback received is critical to the CDRH guidance program to ensure that stakeholder needs are met. Comments and suggestions can also be emailed at any time to the CDRH Guidance Program.

Metrics for FY 2024 A-list and B-list Publication

Stakeholder feedback on guidance priorities is important to ensure that the CDRH guidance program meets the needs of stakeholders. The feedback received on the FY 2024 list was mostly in agreement, and CDRH continued to work toward issuing the guidances on this list. In FY 2024, CDRH published 17 of 24 guidances on the FY 2024 list (16 from the A-list, 1 from the B-list).  

Metrics for the Finalization of Draft Guidance Documents

CDRH has committed to finalize, withdraw, reopen the comment period, or issue a new draft guidance for 80% of draft guidance documents within 3 years of the close of the comment periods and 100% within 5 years of the close of the comment periods, as resources permit. The percentage of draft guidances issued FY 2016 onward for which CDRH has taken an action within 3 years or within 5 years of the comment period close is as follows:

Fiscal Year	Action taken within 3 years	Action taken within 5 years
FY 2016	23 of 29 (79%)	26 of 29 (90%)
FY 2017	6 of 6 (100%)	6 of 6 (100%)
FY 2018	22 of 24 (92%)	23 of 24 (96%)
FY 2019	23 of 25 (92%)	24 of 25 (96%)
FY2020	9 of 10 (90%)	10 of 10 (100%)
FY2021	9 of 9 (100%)	9 of 9 (100%)
FY2022	13 of 15 (87%)	5 years not yet reached

In addition, in FY 2024, 2 draft guidances issued prior to October 1, 2018, remain for which no action has been taken yet, and CDRH has been continuing to work towards taking an action on these remaining draft guidances. Looking forward, in FY 2025, CDRH will strive to finalize, withdraw, or reopen the comment period for 50 percent of existing draft guidances issued prior to October 1, 2019.

Applicability of Previously Issued Final Guidance

In FY 2024, CDRH received comments regarding guidances issued in 2014, 2004, and 1994 and the revision of several guidance documents are being considered and pursued as resources permit. Five guidances that no longer reflect the FDA’s current thinking were withdrawn.

Related Links

CDRH Proposed Guidance Development