Devices Eligible for Third-Party Review

FDA’s program for third-party review of 510(k) submissions was expanded to include nearly 700 device categories. However, there are sometimes exceptions within a category—call us to discuss them.

For a complete list of categories, click here to go to an FDA webpage that lists both the 21CFR regulation number and the 3-letter ProCodes under each number. To see the FDA list for a particular specialty panel, click on the appropriate link, below.

Anesthesiology Panel
Clinical Chemistry Panel
Cardiovascular Panel
Dental Panel
Ear, Nose and Throat Panel
Gastroenterology-Urology Panel
Hematology Panel
General Hospital Panel Immunology Panel
Microbiology Panel
Neurology Panel
Obstetrics and Gynecology Panel
Ophthalmology Panel
Orthopedic Panel
Pathology Panel
Physical Medicine Panel
Radiology Panel
General and Plastic Surgery Panel
Clinical Toxicology Panel
Unclassified

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