November 8, 2023
Agency seeks comment on plans to address AI, cybersecurity, emergency use authorizations, real-world evidence, sex- and gender-specific data, and more
The Food and Drug Administration's Center for Devices and Radiological Health (CDRH) recently released an ambitious slate of "A-list" and "B-list" priorities for guidance documents to be issued during the 2024 fiscal year that could impact medical device manufacturers and makers of diagnostic tests.
The agency has committed to prioritizing industry guidance across 3 final and 18 draft documents covering a diverse range of topics, including AI, cybersecurity, pulse oximeters, medical device shortages, emergency use authorization review, diagnostic tests for emerging pathogens, real-world evidence, and sex- and gender-specific data in device clinical studies.
FDA is seeking public and manufacturer feedback on the list of guidance documents and their relative priority on the A- and B-lists through Dec. 11. The agency also welcomes suggestions for new or different guidance documents including the reasons why guidance on the topic is needed.
FDA's A-list includes three final guidance documents
Of the 21 prioritized guidance documents, three are considered FDA final guidance. These include:
- Remanufacturing of Medical Devices (promoted from FDA 2022 B-list)
- 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
2024 agency priorities include five B-list guidance promotions from last year
The other 18 draft documents prioritized for the 2024 fiscal year include guidance on using chemical analysis for medical device biocompatibility assessment; lifecycle management and premarket submission for AI/ML-enabled devices; cybersecurity guidance for connected medical devices; and assessing clinical and scientific evidence in pulse oximeter performance.
FDA's current A-list also contains five guidance documents promoted from last year's B-list. These include guidance documents covering the conformity assessment accreditation scheme, biocompatibility, and the evaluation of sex- and gender-specific data in medical device clinical trials.
FDA's announcement also contains a B-list of expected guidance documents for 2024:
- Computer Software Assurance for Production and Quality System Software (final)
- Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers (final)
- 3D Printing Medical Devices at the Point of Care (draft)
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