Devices & Diagnostics Letter

CDRH would move into a “death spiral” if Medical Device User Fee Act (MDUFA) legislation is not reauthorized this summer, director Jeffrey Shuren warned at a Senate Health, Education, Labor & Pensions (HELP) committee hearing Thursday.

Stryker’s Wingspan stent could be yanked from the market if the FDA heeds March 23 recommendations of its Neurological Devices Panel.

A $3 billion decline in the U.S. device market — driven by the impending device tax, changing healthcare reimbursement policies, increased foreign competition, or some combination of those forces — could cost the U.S. economy $8 billion and 39,000 jobs, an AdvaMed report warns.

FDA staff will have firmer guidelines on performing benefit-risk analyses during device PMA and de novo classification reviews, under a newly finalized guidance.

Patient advocacy groups used a March 28 FDA public forum on reauthorization of device user fees to lambast the FDA for sidelining them in recent Medical Device User Fee Act (MDUFA) negotiations.

The FDA’s Orthopaedic and Rehabilitation Devices Panel will meet June 27–28 to address growing concerns about the safety and efficacy of metal-on-metal (MoM) arthroplasty systems.

Thoratec has voluntarily recalled its HeartMate II left ventricular assist system after receiving multiple reports of product parts falling off during X-rays and surgeries, the FDA says.

Biomet will pay the U.S. government $22 million to settle whistleblower allegations the orthopedic devicemaker bribed foreign physicians to use its products.

A new Government Accountability Office (GAO) report confirmed what many in the device industry already know: Device review times have gotten consistently longer in recent years, even as the agency meets many review time goals set under the Medical Device User Fee Act (MDUFA).

Lucero Medical, an Ohio-based maker of vertebral body replacement devices, has been warned for lacking a slew of basic manufacturing procedures and for various 510(k) clearance violations.