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FDA 510(k) Third Party Services
As an Accredited Person (AP) TÜV Rheinland is authorized by the U.S. Food and Drug Administration (FDA) to perform Third Party Reviews and Third Party Inspections.
Under the Third Party Review program TÜV Rheinland is authorized to conduct the primary review of 510(k)’s for eligible devices. TÜV Rheinland conducts the primary review of the 510(k), then forwards its review, recommendation, and the 510(k) to FDA. By law, FDA must issue a final determination within 30 days after receiving the recommendation of an Accredited Person. 510(k) submitters who do not wish to use an Accredited Person may submit their 510(k)’s directly to FDA.
Under the Third Party Inspection Program, eligible manufacturers of class II or class III medical devices may elect to have third parties conduct their inspections against the U.S. Quality System Regulations instead of the FDA. The intention of the program is to reduce the burden of multiple inspections on manufacturers.
