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FDA Agrees To Waive User Fees For Reviews Of Lab-Developed Tests

Although FDA is still developing its lab-developed test regulatory framework, it has agreed not to collect user fees to support its planned review of the tests.

FDA will not collect user fees to support its planned pre-market reviews of laboratory-developed tests, according to a draft agreement with industry.

The agency and industry agreed to a draft commitment letter and proposed legislative language for the reauthorization of the Medical Device User Fee Act in negotiations that concluded Feb. 17. The letter and legislative language are undergoing concurrent review at HHS and the Office of Management and Budget, and will be published in the Federal Register for public comment before being sent to Congress

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