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Medical Devices / Regulatory Affairs

FDA Lays Out Possible LDT Oversight Approach

Jan. 26, 2017

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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