FDA Publishes Lists of Planned Medical Device Guidances for Fiscal Year 2024

Recommendation

2/3 May 2024

Process Validation - Live Online Training

In October 2023, the Center for Devices and Radiological Health (CDRH) published a list of new guidance documents planned for fiscal year 2024 (1 October 2023 - 30 September 2024), as well as older guidance documents that will be reviewed for current relevance.

The CDRH is the division of the FDA responsible for regulating medical devices (MDs). The basis, e.g. also for FDA inspections of medical device manufacturers, is the corresponding guidance, policies, etc. of the CDRH.

As in previous years, the CDRH divides the list into two categories: "A" and "B" priority. The documents listed under "A" priority are to be released first. If resources are still available after the "A priorities" have been worked through, the intention is then to publish these documents listed under B in 2024. In a relatively pragmatic way, the FDA has mainly "packed" the finalization of current draft documents under this heading. The list of guidance documents to be reviewed for relevance in 2024 is considerably more extensive. They include guidance from 1984, 1994, 2004 and 2014.

What is planned for the A list?  First, final guidelines are concerned:

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

Second, also drafts are addressed:

• 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)

 "Metrics" regarding the A and B list in fiscal year 2023 and finalization of draft documents conclude the document. Comments will be accepted until 11 December 2023.

For more details, please see the complete list.