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

Article preview from "The Gray Sheet"-  March 5, 2012

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

Article preview from "The Gray Sheet"-  March 5, 2012

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. (See in this issue "Industry, FDA Agree On Draft User Fee Commitment Letter" — "The Gray Sheet," Mar. 5, 2012.)

One primary area of discussion between the parties since they reached an agreement “in principle” a month ago was a proposed user-fee waiver for laboratory-developed tests, according to meeting minutes recently released by FDA.

Laboratory-developed tests are created and performed as diagnostic services within a laboratory and are not currently subject to FDA approval or clearance, based on an enforcement discretion policy by the agency. But FDA is developing a new framework to actively regulate LDTs for the first time. (See "FDA: Draft Guidance For Laboratory-Developed Test Regs Taking Extra Time" — "The Gray Sheet," Apr. 25, 2011.)

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