CDRH Proposed Guidances for Fiscal Year 2025 just released

2 days ago, The FDA’s Center for Devices and Radiological Health (CDRH) just released the Proposed Guidances for Fiscal Year 2025.

Historically, CDRH is publishing its list in October each year, a first difference with CDER & CBER which are also doing the same but later in the year. Another main difference is that CDRH released a full list divided between:

• The A-list: Identifies the priority guidance documents CDRH intends to publish during FY 2025.
• The B-list: Identifies the guidance documents CDRH intends to publish as resources permit during FY 2025.
• “Under Construction” list: Identifies guidance documents that CDRH intends to develop as resources permit and that are not on the A- or B-list.
• Retrospective review list: Identifies the final guidance documents that were issued in 1985, 1995, 2005, and 2015 that CDRH commits to reviewing to ensure they continue to represent the Agency’s current thinking.

In each of them, Final & Draft Guidances are presented.

Unless rules are going to be harmonized in 2025 between the 3 entities, CDER & CBER are publishing less comprehensive lists (Final Guidances are not always listed).

For CDRH in 2025, we can highlight the 7 Guidances (personal choice):

A-List

Final Guidance Topics:

• Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff
• Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (revision)

Draft Guidance Topics:

• Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management Considerations and Pre-market Submission Recommendations

B-List

Final Guidance Topics:

• Computer Software Assurance for Production and Quality System Software

Draft Guidance Topics:

• Policy for Regulatory Status of Device Software Functions (revision of Policy for Device Software Functions and Mobile Medical Applications)

Under Construction List

Draft Guidance Topics:

• Clinical Evidence Considerations for Digital Mental Health Treatment Devices, including Computerized Behavioral Therapy Devices

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidances-fiscal-year-2025-fy2025