The FDA has released draft guidelines to update and improve the evaluation of automatic class III designation for some low- to moderate-risk medical devices that do not meet the requirements for 510(k) clearance. Devices are only subjected to the de novo process after being rejected by the 510(k) process, and the new guidelines aim to pave the way for a concurrent 510(k) and de novo process that will eliminate duplicative data requirements and shorten the review process.

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