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Medical Devices / Regulatory Affairs / Submissions and Approvals

FDA Reports Underused Third Party Review Program for 510(k)s

Jan. 31, 2018

Under the FDA’s third party review program, there is only one accredited organization that has completed at least five 510(k) submissions, despite being launched nearly two decades ago.

Out of the seven organizations currently in the program, Regulatory Technology Services has been the most active so far, with a total of 11 510(k) submissions accepted by the FDA, according to a new CDRH report outlining performance metric results as of Q1 2018.

The other six — AAB, the Center for Measurement Standards of Industrial, the New York State Department of Health, the Nordic Institute of Dental Materials, the Third Party Review Group, and TUV SUD America — collaborated with agency staff in the review of another 7 submissions.

Under the latest reauthorization of MDUFA, the agency only committed to providing complete performance reports on organizations with at least five 510(k) submissions.

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