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In a farewell talk at the Brookings Institution, outgoing US FDA Commissioner Scott Gottlieb said a top unfinished business that he hopes gets done after his April departure is legislation to regulate laboratory developed tests. While FDA had been looking to issue guidance on LDTs, he argues there isn’t sufficient legal authority for the agency to regulate the sector.
Latest From United States, Policy & Regulation
US FDA Commissioner Scott Gottlieb spoke with Medtech Insight about the agency’s decision to put the LDT issue to Congress instead of using guidance-making.
US Senate Finance Committee leaders say some physicians may have failed to disclose their physician-ownership interests in entities that offer medical supplies to the physician’s own practice, as required under the Physician Payment Sunshine Act. The legislators on March 19 prodded the Health and Human Services' Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) to take a closer look into these arrangements.
US FDA has updated a final guidance on the use of animal components in medical devices. The new version incorporates precautions intended to limit the transmission of a wider range of diseases, while the original focused on bovine spongiform encephalopathy (mad cow) disease.
New US FDA analysis of paclitaxel-coated devices to treat peripheral arterial disease matches previous reports of an increased death risk tied to use of the devices. The agency is encouraging providers to look to other treatment options while analysis continues.
Device-makers will have to take a more proactive approach to understanding the safety of biomaterials they use for their implanted devices, and how these materials might affect patients during post-market use, industry attorney Michele Buenafe of Morgan Lewis & Bockius LLP told Medtech Insight in a March 18 interview.
In an exclusive interview with Medtech Insight, MDMA's Mark Leahey – one of industry's top lobbyists – talked about the group's priorities over the past year and its continued work on hot-button issues, including medical device-tax repeal, reimbursement and implementing MDUFA IV provisions. He also discussed the imminent departure of US FDA Commissioner Scott Gottlieb and the recent federal government shutdown.
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