Quality and Regulatory Compliance within the medical device industry has become increasingly complex. FDA, as well as the various international agencies, are continually releasing new regulations and guidance documents designed to enhance quality, consistency, timeliness, and ultimately patient safety. It is critical for manufacturers to not only fully understand all relevant literature when published but also to anticipate topics to be addressed by the authorities in order to get a jump-start on readiness activities.
With that in mind, FDA’s Center for Devices and Radiological Health (CDRH) published its official 2024 plan with respect to guidance documents impacting the medical device industry. Industry stakeholders are urged to review the listing below and initiate appropriate discussion and preparation with company leadership, relevant employees, and external consultants and advisors in order to ensure a smooth, efficient, and effective implementation once the applicable documents are released.
A-List: Prioritized Guidance Documents that CDRH Intends to Publish in FY2024
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 Predetermined 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Draft Guidance Topics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 Guidance Development Resources Permit, in FY2024
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
