MedTech Dive October 13, 2023
The administration is ramping up production of medtech guidance, adding 18 draft documents to the list of priorities for the upcoming financial year.
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...