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Set Alert for Policy and Regulation United States

Unfinished Business: LDT Legislation A Top Priority For Departing FDA Chief Gottlieb

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.

FDA Leadership Policy
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Podcast: Gottlieb Addresses LDT Legislation At Brookings

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.

FDA Legislation

Physicians Failing To Disclose Supplier, POD Arrangements Fuel Kickback Concerns, Senators Say

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.

Reimbursement Enforcement

Beyond Mad Cow: FDA’s Updated Animal Component Guidance Looks To Limit Spread Of More Diseases

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.

FDA Guidance Documents

FDA Tells Providers To Limit Use Of Paclitaxel-Coated Stents

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.

Safety Medical Device

FDA Focusing More On Safety Of Device Biomaterials, Attorney Warns

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.

Regulation Safety

Podcast: MDMA CEO Mark Leahey On Industry's Hot Topics

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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