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22 February 2017
In an unusual move, the Food and Drug Administration (FDA) published a discussion paper on January 13 2017 entitled "Discussion Paper on Laboratory Developed Tests", which proposes a new regulatory framework for laboratory-developed tests. The discussion paper describes a risk-based approach that differs significantly from the FDA's initial proposal in a draft guidance document issued in 2014 and reflects a lighter touch for most laboratory-developed tests.
The discussion paper is not enforceable and does not represent the formal position of the FDA, nor does it constitute a final version of the draft guidance. Rather, issuing the paper allows the FDA to publicise, gauge and build support for its proposals on a controversial topic while avoiding the requirement that the FDA provide notice to Congress 60 days before issuing any final or draft guidance on laboratory-developed tests.
Although the FDA's issuance of a discussion paper on laboratory-developed tests is unexpected, the move is not unprecedented. For example, the FDA first vetted its potential policy approach to next generation sequencing with a preliminary discussion paper in 2014. The FDA then published additional discussion papers and held public workshops to gather stakeholder input before releasing two draft guidance documents in July 2016. The proposals announced in the next generation sequencing draft guidance documents tracked certain key provisions that were advanced in the discussion papers.
The FDA's proposal for regulatory oversight of laboratory-developed tests reflects a risk-based, phased-in approach, but backs away from many provisions of the draft guidance.
There are a number of key provisions in the FDA's proposal:
Notable differences from the proposal outlined in the 2014 draft guidance include the following:
The FDA will likely solicit further stakeholder participation regarding the new proposals outlined in the discussion paper, possibly by holding a public workshop. Industry should carefully consider the proposals made in the discussion paper and be prepared to provide meaningful input.
For further information on this topic please contact Nancy K Stade, Allison Fulton or Tina Papagiannopoulos at Sidley Austin LLP by telephone (+1 202 736 8000) or email (firstname.lastname@example.org, email@example.com or firstname.lastname@example.org). The Sidley Austin website can be accessed at www.sidley.com.
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