RTS was initially accredited by the FDA as a third-party reviewer in 2003. Since then, we have reviewed more 510(k) submissions than any other 3P Review Organization and have consistently conducted more reviews annually than any other 3PRO in the industry.
We are a highly qualified team of reviewers who possess the scientific, technical and regulatory expertise to review the broad range of Class I and Class II medical devices that are eligible for 3PRO review. That range of expertise has resulted in RTS being the only third-party review organization to be accredited by the FDA to review medical devices in all twenty medical specialties/review panels on the Agency’s list of devices eligible under the FDA’s 3P510(k) Review Program.
Our experience and depth of expertise has also enabled us to consistently achieve the fastest turnaround time in the industry. We routinely complete an administrative review within 24 hours and a substantive review on average of 14 days.
We are committed to continuing to work with the FDA to promote the Third-Party Review Program so medical device manufacturers will be able to bring their products to market faster and so the FDA can focus more of its resources on the evaluation of pioneering technologies that have the potential to transform the medical field provided their safety and effectiveness can be assured.
We invite you to contact us with any questions about our 3P review service and/or to learn if your device is eligible for the FDA 3P510k Review Program.