Regulatory Technology Services

Regulatory Technology Services (RTS) is the #1 FDA Accredited Third Party 510k Review Organization to perform 510(k) reviews under the FDA’s Accredited Persons Program (3P510k).

Since our inception, RTS engineers, scientists, and clinicians have reviewed over 1,500 submissions averaging 10-14 days from receipt of submission to completion of substantive review.

RTS is the leading and longest serving FDA Accredited 3P510k Review Organization reviewing over 70% of all reviews completed by Third Party Organizations, year after year. In business since 2003, RTS has reviewed and cleared over 1,500 510(k) submissions. RTS has a highly qualified team of reviewers with the scientific, technical and regulatory expertise to review a broad range of Class I and Class II medical devices. RTS is also the only FDA Accredited 3P510k Review Organization that has the eligibility to review medical devices in all twenty of the Medical Specialties / Review Panels listed on the FDA List of Devices for 3P510k Third Party Review (go.usa.gov/xVUX7).

One of the key drivers cited by the FDA for creating the FDA 3P510k Accredited Persons Program is "enhanced speed to market" and no organization embraces this ideal better than RTS. Our unparalleled speed and experience assures you the fastest turnaround time for your eligible 510(k) product review and clearance. We are routinely months faster reviewing and clearing 510(k) submissions versus the FDA, with administrative review completed in 24 hours and substantive review completed in 10-14 days.