List of Devices for Third Party Review
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| Database updated April 15, 2024 | |
This page lists devices currently eligible for third-party review under the FDA's 510(k) Third Party Review Program, formally, the Accredited Persons Program. Premarket Notifications ["510(k)'s"] for devices on this list can be submitted to FDA-recognized 3P510K Review Organizations (Accredited Persons) in lieu of FDA. Information on the 510(k) Third Party Review Program, including links to this page and to a list of accredited persons, is available at the 510(k) Third Party Review Program website.
How to use the list of eligible devicesThe list has four columns:
- The first column provides the classification regulation number for each device from Title 21, Code of Federal Regulations (CFR), Parts 862-892. A classification regulation identifies a generic type of device and specifies the regulatory class that fda has assigned to the device.
- The second and third columns show the classification name for the device from the CFR, and the class of the device, respectively. In the second column, under each classification regulation name, one or more 3-letter product codes appear, along with the device name associated with each product code. Product codes represent specific subsets of devices grouped under the same classification regulation name. Manufacturers should determine the classification of their device at the product code level that most appropriately identifies their device(s).
- The fourth column provides a link to available standards to assist manufacturers in the preparation-and 3P510k review organizations in the review-of 510(k)s for eligible devices.
Please see the 510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations for exceptions to the list.
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