Tag Archives: LDTs

FDA Issues Discussion Paper on Possible Regulatory Approach for Laboratory Developed Tests

On January 13, 2017, the U.S. Food and Drug Administration (FDA or Agency) released a discussion paper synthesizing public feedback on FDA’s 2014 draft guidance documents and outlining a possible approach to regulation of laboratory developed tests (LDTs) (Discussion Paper). This approach is intended to “advance the public discussion by providing a possible approach to … Continue Reading

Obama Administration Will Not Finalize LDT Framework Guidance

On November 18, 2016, the U.S. Food and Drug Administration (FDA or Agency) announced that it would not finalize the draft guidance entitled Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (Draft Guidance) prior to the end of the Obama administration. As we previously reported, FDA issued the Draft Guidance on October 3, 2014.  … Continue Reading

Senate HELP Committee Moves Forward With Companion Legislation to 21st Century Cures

As previously covered on this blog and in our alert, the U.S. House of Representatives passed the 21st Century Cures Act (H.R. 6) in July 2015.  The U.S. Senate Committee on Health, Education, Labor, and Pensions (commonly referred to as the “HELP Committee”) has worked on companion legislation to the House bill and, since February … Continue Reading

Lab Association Petition Challenges FDA’s Authority To Regulate LDTs Under the FDCA

The American Clinical Laboratory Association (ACLA) filed a citizen petition on June 4 challenging Food and Drug Administration (FDA) authority to regulate laboratory developed tests (LDTs) as “devices” under the Federal Food, Drug, and Cosmetic Act (FDCA).  ACLA’s petition requests that FDA refrain from promulgating any draft or final guidance or rule purporting to regulate … Continue Reading