CDRH Releases List of Proposed 2024 Guidance Documents

By MedTech Intelligence Staff
October 10, 2023


• Categories: 05-Quality/Regulatory, AI/ML, Cybersecurity, Medical Devices, RC - Medtech Regulatory Resource Center

Change control plans for AI/ML, remanufacturing of devices and medical device shortages are among the guidances the FDA Center for Devices and Radiological Health (CDRH) is prioritizing in 2024. On October 10, CDRH published a list of guidance documents it intends to publish in the coming year and asked for stakeholder feedback to be submitted by December 11. Specifically, CDRH is seeking comments on the relative priority of guidance documents on the A-list and B-list (below), as well as proposed policy or information for the FDA to consider for inclusion in these guidances. The agency noted that it also welcomes suggestions for new or different guidance documents and the reasons why a guidance on the topic is needed.

A-List: Prioritized Guidance Documents include:

Final Guidance Topics

• Remanufacturing of Medical Devices
• Medical Device Shortages – Implementation of Section 506J of the Federal Food, Drug, and Cosmetic Act
• Marketing Submission Recommendations for A Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

Draft Guidance Topics

• 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)

B-List: Guidance Documents that CDRH Intends to Publish, as Resources Permit, include:

Final Guidance Topics

• Computer Software Assurance for Production and Quality System Software
• Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers

Draft Guidance Topics

• 3D Printing Medical Devices at the Point of Care

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 “Instructions for Submitting Comments on the CDRH Fiscal Year 2024 Proposed Guidance Development.” Submit electronic comments to www.regulations.gov.