FDA CDRH Releases Proposed Guidances for 2023

The Center for Devices and Radiological Health (CDRH) has published a list of guidance documents it intends to publish in 2023. The list is prioritized by an “A-List” of documents it intends to publish, and a “B-List” of documents it intends to publish as resources permit.

In the coming year, the FDA will also reopen for comment select final guidance documents issued in 2013, 2003, 1993 and 1983 that are subject to focused retrospective review.

A-List Final Guidance Topics for device developers include:

Remanufacturing of Medical Devices
Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
Content of Premarket Submissions for Device Software Functions
Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program
Breakthrough Devices Program (revised)

Draft Guidance Topics:

Voluntary Malfunction Summary Reporting (VMSR) Medical Device Reporting (MDR) for Manufacturers
Clinical Considerations for Medical Device Premarket Submissions Targeting Opioid Use Disorder
Select Updates for Guidance for the Breakthrough Devices Program
Electronic Submission Template for De Novo Request Submissions

B-List Draft Guidance Topics include:

Chemical Analysis for Biocompatibility Assessment of Medical Devices
Marketing Submission Recommendations for A Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies (revision of Evaluation of Sex-Specific Data in Medical Device Clinical Studies)
The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
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) Pilot Program
Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program