New US FDA 510(k) Draft Guidance for Deciding When to Submit a 510(k) for a Change to an Existing Device:
Are you currently a manufacturer doing business within medical devices in the USA and is your product cleared by the FDA as a 510(k)?
Then you need to be aware of that the FDA on August 8 has issued an updated draft guidance for manufacturers deciding whether to submit a new 510(k) when making modifications to medical devices already in the market.
Furthermore, a complementary draft guidance on software modifications was also issued.
The updated FDA guidance retains the basic format and content of the original guidance issued by the FDA in 1997, but with updates for clarity. FDA also drew from existing policy and related guidance in updating the draft guidance document, including: