Third-Party Review Program

The Center for Devices and Radiological Health (CDRH) has implemented a Third-Party Review Program.67 This program provides an option to manufacturers of certain devices of submitting their 510(k) to private parties (Recognized Third Parties) identified by FDA for review, instead of submitting directly to CDRH. By law, FDA must issue a final determina­tion within 30 days after receiving the recommendation of an Accredited Person.