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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
Cook Vascular was handed an FDA warning letter for marketing the Cook Evolution RL and the Shortie RL Bi-directional Dilator Sheath Sets without marketing clearance or approval. Read More
CINCINNATI — The FDA’s increasing emphasis on human factors testing is creating new momentum for labeling research, an industry consultant told conference-goers at the FDA/Xavier University MedCon conference. 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The National Institute for health and Care Excellence has issued final draft guidance updating advice on the most clinically and cost-effective choices for devices to treat irregular heartbeats or heart failure.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CINCINNATI — Manufacturers of combination products can expect draft guidance on current good manufacturing practices in the next several months, staffers in the FDA’s Office of Combination Products said Thursday.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
The FBI has warned healthcare providers to expect an upsurge in cybercrimes against health information systems and to make sure medical devices aren’t causing vulnerabilities in their networks. Read More
Routine quality system surveillance inspections of foreign devicemakers increased by 93 percent in 2012, according to newly released FDA data. Read More