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CDRH brought in nearly 50 percent more device user fees in fiscal year 2013 than in 2012, according to the FDA’s quarterly report on MDUFA performance. Read More
The National Institute for health and Care Excellence has issued final draft guidance updating advice on the most clinically and cost-effective choices for devices to treat irregular heartbeats or heart failure. Read More
Manufacturers of surveying, leveling or alignment laser products cannot avoid the SLA designation simply by promoting their lasers for scientific, general purpose or other uses, the FDA says. Read More
CINCINNATI — Manufacturers of combination products can expect draft guidance on current good manufacturing practices in the next several months, staffers in the FDA’s Office of Combination Products said Thursday. Read More
CINCINNATI — With September’s deadline for displaying unique device identifiers on high-risk devices just around the corner, rollout for many manufacturers is well underway. Read More
CINCINNATI — CDRH’s Office of Compliance expects to begin work on a public database of device quality information, such as MDR reports, by the end of the year, OC Director Steven Silverman told devicemakers Wednesday at the FDA/Xavier University MedCon conference. Read More
As the July 22 deadline for complying with new EU requirements on hazardous substances approaches, some manufacturers of medical devices and active implantable medical devices are feeling a financial squeeze. Read More