FDA RELEASES TWO FINAL MEDICAL DEVICE GUIDANCE DOCUMENTS: DECIDING WHEN TO SUBMIT A 510(K)

摘要

The US Food and Drug Administration (FDA) has released two final guidance documents: Deciding When to Submit a 510(k) for a Change to an Existing Device, which applies to medical device changes broadly, and Deciding When to Submit a 510(h) for a Software Change to an Existing Device, which focuses on software-specific changes and complements the broader guidance document. The first document applies to changes made to medical devices placed on the US market and includes sections on sterilisation and biocompatability.