Current List of Accredited Persons for 510(k) Review under the FDA Modernization Act of 1997
Database Updated 11/06/2009
This page provides information on persons
accredited (as of the above date of revision) to review selected premarket notifications
[510(k)s] and the devices they may review. Information on this list will be updated
within 10 working days after the date reflected on the third party's accreditation
letter. Each classified device type on the list of devices eligible for Third Party
Review has one or more product codes associated with it. Devices eligible for review
by Third Parties are limited to the product codes shown on the list of eligible
devices. Please refer to the List of Devices for Third Party Review Under the FDA
Modernization Act (FDAMA) of 1997 to assure your device is eligible for the Accredited
Person Program. To-date, FDA has not withdrawn accreditation from any Accredited Person.
