[Answer] a 510(k) premarket notification is submitted when?

Answer: when the new device is to be marketed is substantially similar (equivalent) to one already on the market

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a 510(k) premarket notification is submitted when? manufacturer submit a new premarket notification (510(k)) to the Agency . This document supersedes FDA’s guidance Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1) issued ... Wed Mar 28 2018 · Premarket Notification 510(k) Explained. If you’re developing a medical device that is similar to one already on the market the 510(k) path is likely the way to go. It’s the fastest and most economical way to get your medical device cleared. FDA guidelines state that a 510(k) should be submitted at least 90 days before the device is marketed . PreMarket Notification Submission. • Pertaining to Section 510(k) of Medical Device Amendments (1976) to FD&C Act • Preamendment devices on the market prior to Fri May 28 1976 are grandfathered • Required for dev...

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