Dive Brief:
- The Food and Drug Administration is ramping up production of medtech guidance, adding 18 draft documents to the list of priorities for its 2024 financial year.
- In 2022 and 2023, the FDA’s A-lists featured 10 and four draft documents, respectively. The plan for 2024 is more ambitious, with the administration aiming to draft 18 documents on topics such as artificial intelligence, cybersecurity, real-world evidence and pulse oximeters.
- Five of the priority drafts were on the FDA’s B-list last year. The B-list for 2024 is relatively short, featuring two final guidance documents and one draft text on 3D printing at the point of care.
Dive Insight:
The list of draft documents touches on many topics the agency has discussed over the past year. Lifecycle management and premarket submissions for devices enabled by AI and machine learning top the list of drafts scheduled for publication in the coming year. The FDA also plans to post drafts on predetermined change control plans, cyber devices and pulse oximeters.
Three of the drafts cover emergency use authorizations, a process with which the FDA gained experience in the COVID-19 pandemic. The draft documents could provide a framework for future crises by setting out the FDA’s views on enforcing rules during the immediate diagnostic response to an emerging outbreak, the validation of tests and the factors that will inform its policy on unapproved tests.
Across the five drafts promoted from the B-list, the FDA plans to provide advice on biocompatibility, the evaluation of sex- and gender-specific data in medical device clinical trials, and its conformity assessment accreditation scheme.
The FDA’s final guidance A-list features three documents. One document, on remanufacturing medical devices, is left over from last year. The other two documents cover medical device shortages and advice on predetermined change control plans for device software enabled by AI and ML.
With 21 draft and final documents on the A-list, the agency has published a short B-list of lower-priority texts. The FDA’s B-list includes final guidance on computer software assurance and voluntary malfunction summary reporting, plus a draft document on 3D printing medical devices at the point of care.