FDA Passes The Buck On LDTs, But Floats Ideas

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.)