While judging the Medicines and Healthcare products Regulatory Agency’s (MHRA) response to the PIP silicone breast implant scandal basically sound, a new review by the UK Department of Health (DOH) finds MHRA needs better access to information on devices to preclude similar public health scares in the future.
Category Archives: Devices & Diagnostics Letter
A class action lawsuit that used FDA Form 483 inspection reports to demonstrate that KV Pharmaceutical made false or misleading statements regarding its regulatory compliance can proceed even though inspection reports are not final agency determinations, an appeals court ruled.
There’s little chance that FDA premarket clearance and Centers for Medicare & Medicaid Services coverage with evidence development (CED) decisions will be coordinated in the near future, Louis Jacques, director of CMS’s Coverage & Analysis Group, said June 1 at the Medical Device Manufacturers Association annual conference in Washington, D.C.
The number of internal scientific disagreements over device approvals has waned since late 2009, when the FDA implemented new procedures for handling such disputes, but many employees are still hesitant to raise scientific concerns with agency management, according to a new report by the HHS Office of Inspector General.
The House Appropriations Committee subcommittee that oversees FDA funding recommends fiscal 2013 appropriations that would slightly reduce agency spending. A full committee markup of the bill, as yet unnumbered, hasn’t been scheduled but is expected later in June.
Johnson & Johnson’s (J&J) Ethicon unit will halt sales of some vaginal mesh products implicated in a class action lawsuit, but says it needs time to conduct the withdrawal properly.
Opponents of the medical device excise tax, mandated in the 2010 Affordable Care Act, are one step closer to repealing the contentious measure, after the House voted 270-146 to pass H.R. 436, the Protect Medical Innovation Act.