FDA/HHS Documents

DTWG is providing access to certain public materials from other stakeholders as a convenience.  The inclusion of this material does not necessarily reflect the positions or views of DTWG or its members.


  • August 19, 2020 – Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests (HERE)
  • May 22, 2020 – HHS Memo to FDA on Authority to Regulate LDTs (HERE)
  • January 13, 2017 – Discussion Paper on Laboratory Developed Tests (LDTs) (HERE)
  • November 18, 2016 – FDA Delays Finalization of Lab-Developed Test Draft Guidance, Regulatory Focus (HERE)
  • November 17, 2015 – Jeff Shuren Testimony before the Committee on Energy and Commerce Subcommittee on Health (HERE)
  • FDA Draft Guidance (October 2014): Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (HERE)
  • FDA Draft Guidance (October 2014): Notification and Medical Device Reporting for Laboratory Developed Tests (HERE)