Devices & Diagnostics Letter

The final sticking point in FDA-industry MDUFA III negotiations centered on disagreement over regulation of laboratory-developed tests (LDTs), newly released meeting minutes show.

In vitro diagnostic tests could see higher Medicare reimbursement levels if legislation aimed at encouraging co-development of tests and treatments for rare conditions is passed by Congress.

The UK’s Medical and Healthcare products Regulatory Agency (MHRA) Tuesday issued an updated alert to medical professionals on managing patients with metal-on-metal (MoM) implants — the same day a British Medical Journal (BMJ) article said the hips may have exposed “hundreds of thousands of people globally” to toxic metal ions.

Two Democrats on the House Energy and Commerce health subcommittee crossed the aisle to join Republicans in approving legislation to repeal the Independent Payment Advisory Board (IPAB).

A proposed FDA survey of healthcare professionals on device labeling design is likely to proceed as planned, if the agency’s response to AdvaMed is any indication.

California-based heart disease equipment maker Thoratec received a Form 483 for failing to thoroughly investigate — and submit a timely medical device report (MDR) for — a complaint involving a patient death that may have resulted from a malfunction of one of its devices.

The FDA won’t reject the Institute of Medicine’s (IOM) controversial recommendations on 510(k) reform over concerns the advisory committee wasn’t balanced, the agency told the Washington Legal Foundation (WLF).

California’s 2,000 biomedical companies face an extra layer of regulation: The state requires device and drug manufacturers to undergo an inspection by the California Department of Public Health’s Food and Drug Branch (CFDB) in addition to federally mandated FDA inspections.

A federal jury has recommended Varian Medical Systems pay the University of Pittsburgh $37 million in damages for infringing patents on cancer treatment techniques developed by university scientists.

The FDA has handed telemetry maker ScottCare a warning for a host of good manufacturing practice (GMP) violations, including improper implementation of corrective and preventive action (CAPA) procedures.

Manufacturers unable to report timely postmarket adverse events during a flu outbreak should notify the FDA and have documents ready explaining the reasons for the delays, the agency says.

The FDA’s current acting chief counsel, who has held the position since August, will be granted permanent status March 12, agency Commissioner Margaret Hamburg told staff Wednesday.