Devices & Diagnostics Letter

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.

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.

The FDA has cited a manufacturer of cranial remodeling helmets on seven areas of documentation and policy flaws.

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.

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.

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.

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.

Backlash over chromium contamination in some drug capsules may hit devices, as China’s State Food and Drug Administration (SFDA) proposes to draw up a “blacklist” of executives who oversee companies in China found to produce substandard or counterfeit medical products.

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.

Pfizer agreed to pull a 60-second direct-to-consumer (DTC) TV ad promoting a pair of drug-device combination products to treat severe allergic reactions after the FDA flagged it for overstating the products’ efficacy.

China is expected to reclassify some in vitro diagnostic (IVD) and medical imaging devices to lower-risk categories this month as part of a reform of its classification system that began in 2009, industry experts say.

Siemens Healthcare Diagnostics has come under FDA scrutiny after an inspection at its Tarrytown, N.Y., plant found the company was marketing a diagnostic test that had never been officially approved.

The FDA is moving toward requiring PMA applications for diagnostics that are paired with specific drugs, rather than the less stringent 510(k) or de novo 510(k) process that are most often used now, said Christine Gathers, senior director of regulatory affairs for Eli Lilly.

A new Federal Communications Commission experimental licensing program will speed research access to the wireless medical body area network (MBAN) spectrum, FCC Chairman Julius Genachowski said at Wednesday’s FCC mHealth Summit.

Cooper Companies has offered $189 million in cash to acquire Danish in vitro fertilization (IVF) devicemaker Origio, in a move analysts say could boost the company’s worldwide surgical profile.