FDA CDRH Releases Proposed Guidances for 2023

By MedTech Intelligence Staff
November 9, 2022


• Categories: 05-Quality/Regulatory, Regulatory

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Draft Guidance Topics: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B-List Draft Guidance Topics include: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