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http://www.fda.gov/CDRH/DEVADVICE/314.html

510K is a process to get FDA clearance to market a medical device.

Any medical device manufacturer (or importer / repackager / relabeler)

* introducing a new medical device * or significantly changing the technology or indication for use, safety or efficacy, to an existing 510K cleared device

must file.

However, the 510K is only for devices that provide the same functionality (substantial equivalence) as an already cleared device (called a predicate device).

Devices that are a new application (without a predicate device) must file a PMA, (not a 510K)-- which usually means clinical trials must be done.

Once a product receives the 510K, it is cleared to market.

However, the company still needs to have a working Quality System.

FDA will conduct periodic inspections to enforce compliance with Quality System Regulations.

I add this additional information because a lot of small manufacturers don't realize the importance of the Quality System regulation and will run into hassles if they don't comply after receiving 510K clearance and before marketing the device.

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Q: Who is required by the FDA to file a 510K?
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