Tuesday, January 17, 2017

FDA Provides White Paper On Its Deferred LDT Regulation Agenda

From 2010-2016, the FDA active promoted an evolving plan to regulate LDTs nationally.   In 2014, it released a detailed roadmap for LDT regulation, for public comment.   Shortly after the election, November 18, FDA announced it was deferring its LDT regulation plan.

Exactly 8 Friday's later, FDA released a 12-page lookback and review of its LDT regulation effort.

  • For the FDA document, here.  
  • For a review online at RAPs, here.
  • Coverage at Genomeweb (subscription), here.

The document is styled as a "discussion paper" and likely captures some of the learnings and changes in plan that occurred inside the FDA between the 2014 draft guidance and the writing of a final guidance that has been deep-sixed.