4/5 October 2023
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:
and it is about drafts:
"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)".