October 23, 2019

October 23, 2019

Subscribe to Latest Legal News and Analysis

October 22, 2019

Subscribe to Latest Legal News and Analysis

October 21, 2019

Subscribe to Latest Legal News and Analysis

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Food and Drug Administration (FDA or Agency) released a discussion paper synthesizing public feedback on FDA’s 2014 draft guidance documents and outlining a possible approach to regulation of laboratory developed tests (LDTs) (Discussion Paper).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 spur further dialogue” and “to respond to stakeholder feedback and attempt to balance patient protection with continued access and innovation.”

This Discussion Paper has no legal status, is not enforceable, and does not address the fundamental legal question regarding FDA’s assertion of jurisdiction over LDTs. In addition, the discussion paper “does not represent a final version of the LDT draft guidance documents that were published in 2014.”

As previously reported, FDA announced on November 18, 2016, that it would not finalize the draft guidance entitled Framework for Regulatory Oversight of Laboratory Developed Tests (Draft Guidance) prior to end of the Obama Administration.

© 2019 Covington & Burling LLP

TRENDING LEGAL ANALYSIS


About this Author

Chris Hanson, Food and Drug Attorney, Covington Law Firm
Associate

Christopher Hanson advises international and domestic clients on regulatory strategies and compliance for medical devices, pharmaceuticals, biological products, cosmetics, animal products, and radiation-emitting electronic products. His broad range of clients include large multinational companies, venture capital firms, industry associations, clinical laboratories, and development-stage companies.

Mr. Hanson has extensive experience counseling clients on interactions with state, federal, and foreign regulatory agencies, including the Food and Drug Administration (...

202-662-5977