该文件<Deciding When to Submit a 510(k) for a Change to an Existing Device>,提供了很多模板,可能可以用来作为评估变更的工具使用。 FDA “shall only request information that is necessary…” and “shall consider the least burdensome means of demonstrating substantial equivalence…” (see section 513...
(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 ...