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Regulatory Focus™ > News Articles > 510(k) Accredited Persons Program—The Case for Third Parties

510(k) Accredited Persons Program—The Case for Third Parties

Posted 01 April 2010

Helping medical institutions provide quality patient care is the top priority for medical device manufacturers, making it critical for them to get products to market quickly. In recent years the US has made strides in simplifying and accelerating FDA clearance of premarket notifications, or 510(k) submissions. One measure was the 1996 Accredited Persons Program, which granted permission for independent third parties to take some of the burden off FDA by conducting primary reviews of 510(k) submissions for lower risk devices and offering their recommendations on device safety and marketability to the agency.


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