(i) Policy Background
Each year, CDRH publishes two lists of guidance scheduled for release during the fiscal year, consisting of The A-list and The B-list. In addition, CDRH also publishes a list of past guidance documents for stakeholders (e.g., device manufacturers and patients) to review and submit comments;
(ii) Policy History
In the Medical Device Users Act of 2012 (MDUFA III) and the Medical Device Users Act of 2017 (MDUFA IV), FDA agreed to:
(i) Publish an annual list of prioritized guidance documents for medical devices (The A-list), and FDA plans to publish the guidance documents on the list within 12 months of the date of publication of the list for each fiscal year;
(ii) Publishing an annual list of guidance documents for medical devices (The B-list), and FDA will publish guidance documents from the B-list each fiscal year as resources permit;
(iii) Provide stakeholders with an opportunity to provide feedback on draft guidance documents;
(iv) Completing, withdrawing, reopening for comment, or issuing new draft guidance on 80 percent of the draft guidance documents within 3 years of the end of the comment period, resources permitting; and completing 100 percent of the guidance documents within 5 years of the end of the comment period;
(iii) FY 2024 Proposed Guidance
1) A-list: divided into final guidance (3 articles) and draft guidance (17 articles)
1.1. Remanufacturing of Medical Devices
1.2. Medical Device Shortages – Implementation of Section 506J of the Federal Food, Drug, and Cosmetic Act
1.3. Marketing Submission Recommendations for A Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
2.1. Artificial Intelligence/Machine Learning (AI/ML)-enabled Device Software Functions: Lifecycle Management Considerations and Premarket Submission Recommendations
2.2. Select Updates for the 506J Guidance: Voluntary Notifications of Discontinuance or Interruption of Device Manufacture
2.3. Select Updates for Premarket Cybersecurity Guidance: Cyber Devices
2.4. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (revision)
2.5. Pulse Oximeters – Assessing Clinical and Scientific Evidence (revision)2.6. Scheduled Change Control Programs for Medical Devices
2.6. Predetermined Change Control Plans for Medical Devices
2.7. 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review (revision)
2.8. Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (revision)
2.9. 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
2.10. Validation of Diagnostic Tests for Emerging Pathogens following a Declaration and Determination under Section 564
2.11. Factors FDA Intends to Consider in Issuing an Enforcement Policy for Unapproved Tests Under a Declaration Under Section 564
2.12. Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance
2.13. Chemical Analysis for Biocompatibility Assessment of Medical Devices
2.14. Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies (revision)
2.15. The Accreditation Scheme for Conformity Assessment (ASCA) Program (revision)
2.16. 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)
2.17. Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program (revision)
2.18. 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)
2) B-list: divided into final guidance (2 articles) and draft guidance (1 article)
1.Final Guide Topics:
1.1. Computer Software Assurance for Production and Quality System Software
1.2. Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
2.Draft Guide Topics:
2.1. 3D Printing Medical Devices at the Point of Care
3) Retrospective review list: list of final guidance documents issued in 1984, 1994, 2004 and 2014
(iv) Exclusive Review.
From the list released, one of the focuses for FY 2024 is all about digital medical devices. the FDA has also recently established a digital health advisory committee (digital health advisory committee), and from these actions we can see the importance that the FDA places on digital healthcare. As well as the FDA’s readiness to adopt a more detailed preparedness policy plan for public health emergencies.
