CDRH Annual Guidance Publication: Prioritizing Medical Device and Radiation-Emitting Product Regulations

The Center for Devices and Radiological Health (CDRH) publishes an annual list of guidance documents related to medical devices and radiation-emitting products for the upcoming fiscal year. The goal of the FDA is to ensure that prioritized guidance documents promote the safe and effective marketing of medical devices in a timely manner.

Key Points:
Guidance Prioritization:

The CDRH publishes two lists:
“”A-list””: A prioritized list of guidance documents for medical devices.
“”B-list””: Additional guidance documents, with the public invited to provide feedback.
Guidance Document Timeline:

The FDA aims to:
Finalize, withdraw, reopen comment periods, or issue new draft guidance for 80% of draft documents within 3 years.
Ensure 100% finalization within 5 years of the close of comment periods.
Flexibility in Publication:

The CDRH may not publish all documents on the A-list or B-list due to factors like staff availability or emerging public health issues.
Annual Retrospective Review:

The FDA reviews previously issued final guidance annually to ensure they reflect the agency’s current thinking. As a result, guidance may be withdrawn or revised during these reviews.
This process is crucial for keeping the regulatory landscape aligned with evolving technologies, ensuring that medical devices and radiation-emitting products are safe, effective, and comply with the latest standards.

Source: https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidance-development#whypost

Region:  United States of America