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Medical Devices / Regulatory Affairs

FDA Lays Out Possible LDT Oversight Approach

Jan. 26, 2017
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After spending months analyzing more than 300 comments on its draft laboratory developed test guidance, the FDA punted the issue to allow more public discussion and a possible legislative solution rather than making the controversial guidance final.

In a discussion paper, the FDA outlined a possible approach that would focus on new and significantly modified high- and moderate-risk LDTs.

The agency acknowledged that there is a growing consensus that additional oversight of LDTs is needed, as reflected in several proposals from organizations representing laboratories and the IVD industry. — Jeff Kinney

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