FDA publishes Lists of planned Medical Device Guidances 2023

Recommendation

23-25 April 2024

Cleaning Validation AND Pre-Course Workshop: Impact of Annex 1 Revision on Cleaning Validation - Live Online Training

In October 2022, the Center for Devices and Radiological Health (CDRH) published a list of new guidances planned for fiscal year 2023 (1 October 2022 - 30 September 2023), as well as older guidances to be reviewed for topicality.

The CDRH is the division of the FDA responsible for regulating medical devices. The basis, e. g. also for FDA inspections of medical device manufacturers, are the corresponding CDRH guidances, policies, etc. The actual list comprises only a little more than one page.

As in previous years, the CDRH divides the list into an "A" and a "B" priority. The documents listed under "A" priority are to be published first. If there are still resources available after the "A priorities" have been processed, it is planned to then also publish these documents listed under B in 2023. Rather pragmatically, the FDA has mainly listed the finalisation of current draft documents under this heading. The four pages with the list of guidance documents that are to be reviewed in 2023 to ensure that they are up to date is considerably more extensive. They include guidances from 1983, 1993, 2003 and 2013. 

What is planned for the A-list?  For once, it is about final guidelines:

• 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)

and it is about drafts:

• 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

"Metrics" on the A and B List in fiscal year 2022 complete the document.

The Guideline List is open for comment until 16 December 2022.

For more details, see the complete list "CDRH Proposed Guidances for Fiscal Year 2023 (FY 2023)".