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FDA Passes The Buck On LDTs, But Floats Ideas

The US agency has backed away from its intent to oversee laboratory-developed tests as set out in a controversial 2014 draft guidance. Instead, in a new discussion paper it is advising legislation to handle the issue. The agency also urges LDT developers to consider recommendations to increase transparency.

After years of intense fighting with the laboratory-developed test lobby, US FDA has confirmed it will not be finalizing a draft LDT guidance and seems to have left regulation of the diagnostic products up to Congress. The decision, which comes in the final days of the outgoing Obama administration confirmed a previous statement from FDA in November, which signaled it was unlikely moving forward with making the guidance final. (Also see "FDA Provides Accessories Guidance, But May Be 'Missed' Opportunity" - Medtech Insight, 4 January, 2017.)

In a discussion paper released by FDA on Jan. 13, the agency stated it has decided to not finalize the guidance and instead is giving Congress the opportunity...

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