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Device firms can avoid regulatory violations and move their products into the market sooner by building quality systems (QSs) into their clinical trials, according to an FDA official.
A former Johnson & Johnson (J&J) executive is reportedly suing the firm, alleging he was fired from J&J's Ethicon unit in May for raising safety concerns about products such as the Ortho Evra contraceptive patch and an arterial cannula, a kind of tubing used in heart bypass surgery.
After examining risks related to the off-label use of drug-eluting stents, an FDA panel has recommended the agency consider mandating labeling changes.
The FDA's Center for Biologics Evaluation and Research (CBER) has approved a new test to screen blood donors for a blood-borne parasite that causes Chagas disease, a potentially fatal parasitic infection.
In a slight concession to the medical device industry, the European Parliament last month agreed to delay a proposed ban on mercury-containing sphygmomanometers (blood pressure monitors) while the European Commission conducts a review into safe and reliable alternatives.
The Centers for Medicare & Medicaid Services (CMS) has announced that the Medicare Coverage Advisory Committee (MCAC) has been rechartered through 2008, which includes updating the committee's role in determining Medicare national coverage.
The FDA's Medical Devices Dispute Resolution Panel meets today to resolve issues related to the premarket approval (PMA) application for the CorCap CSD, a device to treat congestive heart failure manufactured by Acorn Cardiovascular.
Trionix Research Laboratory neglected to perform device change procedures on a faulty product and did not inform the FDA of the malfunction, a recent agency warning letter said.