FDA’s CDRH releases list of proposed guidances for FY 2024

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has named the guidance documents it plans to publish during Fiscal Year 2024, as well as a list of the previously issued final guidances it is seeking feedback on whether to revise or withdraw.

CDRH published an A-list (featuring prioritized device guidances to be published in FY 2024), a B-list (device guidances to be published as resources permit during FY 2024), and a retrospective review list (final guidances issued in 1984, 1994, 2004 and 2014).

For A-list final guidances, CDRH said it plans to tackle the following topics: Remanufacturing of Medical Devices; Medical Device Shortages - Implementation of Section 506J of the Federal Food, Drug, and Cosmetic Act; and Marketing Submission Recommendations for A Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions.

CDRH listed several topics planned for A-list draft guidances:

Artificial Intelligence/Machine Learning (AI/ML)-enabled Device Software Functions: Lifecycle Management Considerations and Premarket Submission Recommendations
Select Updates for the 506J Guidance: Voluntary Notifications of Discontinuance or Interruption of Device Manufacture
Select Updates for Premarket Cybersecurity Guidance: Cyber Devices
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (revision)
Pulse Oximeters – Assessing Clinical and Scientific Evidence (revision)
Predetermined Change Control Plans for Medical Devices
510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review (revision)
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (revision)
Enforcement Policy for In Vitro Diagnostic Product for Immediate Response to an Emerging Outbreak of an Infectious Biological Agent Prior to a Declaration under Section 564
Validation of Diagnostic Tests for Emerging Pathogens following a Declaration and Determination under Section 564
Factors FDA Intends to Consider in Issuing an Enforcement Policy for Unapproved Tests Under a Declaration Under Section 564
Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance
Chemical Analysis for Biocompatibility Assessment of Medical Devices
Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies (revision)
The Accreditation Scheme for Conformity Assessment (ASCA) Program (revision)
Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program (revision)
Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program (revision)
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)

CDRH’s B-list is considerably shorter. The agency said it intends to publish final guidances in FY 2024 as resources permit on two topics: Computer Software Assurance for Production and Quality System Software and Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. CDRH’s B-list only includes one draft guidance topic: 3D Printing Medical Devices at the Point of Care.

CDRH is requesting comments on guidance documents across the three lists by 11 December 2023 and is specifically “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.” The agency is also seeking suggestions for “new or different guidance documents” and the reason they are needed.

For the retrospective review list, CDRH is seeking suggestions about which final guidances should be revised or withdrawn. “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 wrote.

Comments can be submitted through regulations.gov using docket number FDA-2012-N-1021.

CDRH Proposed Guidances (FY 2024)

FDA’s CDRH releases list of proposed guidances for FY 2024

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