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Who needs to submit a 510k?

Manufacturers are required to submit a new 510(k) when a change (or changes) exceeds the 21 CFR 807.81(a)(3) threshold, could docHubly affect the safety or effectiveness of the device, or constitutes a major change or modification in the intended use of the device. This docHub effect could be positive or Deciding When to Submit a 510(k) for a Change to an Existing Device - FDA fda.gov media download fda.gov media download

What is the purpose of a 510 K to determine?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FDC Act).

What triggers a 510k?

The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA, which includes information about the devices intended FDA 510(k) Explained: A Basic Guide to Premarket Notification The FDA Group blog 510k-explained The FDA Group blog 510k-explained

What is 510k clinical data requirements?

The testing required depends on the specific risk and generic type of the device. The FDA requires clinical data for approximately 10%-15% of 510(k)s. This helps the FDA confirm that the device truly is as safe and as effective as a predicate device in cases where non-clinical data alone has not been deemed sufficient.

What is the purpose of 510k?

The Abbreviated 510(k) program offers manufacturers a related flexibility: manufacturers can demonstrate substantial equivalence to a predicate device by providing the results of testing demonstrating that the device comports with previously recognized FDA consensus standards [14], now numbering nearly 1,500 [15]. The 510(k) Third Party Review Program: Promise and Potential nih.gov articles PMC10465388 nih.gov articles PMC10465388

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