Tag Archives: Congress

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Food and Drug Administration (FDA or Agency) released a discussion paper synthesizing public feedback on FDA’s 2014 draft guidance documents and outlining a possible approach to regulation of laboratory developed tests (LDTs) (Discussion Paper).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On November 18, 2016, the U.S. Food and Drug Administration (FDA or Agency) announced that it would not finalize the draft guidance entitled Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (Draft Guidance) prior to the end of the Obama administration. As we previously reported, FDA issued the Draft Guidance on October 3, 2014.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 Republicans Press FDA on Draft Guidances

On May 6, 2014, four of the ten Republicans on the United States Senate’s Committee on Health, Education, Labor, and Pensions (HELP) sent a letter (recently posted by Hyman Phelps) to FDA Commissioner Margaret Hamburg expressing “significant concern” about FDA’s penchant for using draft guidances to make “substantive policy changes.”  In addition to the Committee’s Ranking Member … Continue Reading

Wireless Medical Device Law and Regulation Takes Center Stage at FCC, FDA, and Congress

Wireless medical devices stand at an innovative crossroad between health care, communications, and technology law and regulation. Many of the health and safety aspects of such devices are regulated by the Food & Drug Administration (FDA) and these devices use electromagnetic spectrum regulated by the Federal Communications Commission (FCC).  Lately, regulators at FDA and FCC … Continue Reading
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