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The FDA’s Denver office will host a two-day public workshop on global drug and device safety during an educational conference sponsored by the Association of Food and Drug Officials. Read More
LumiQuick Diagnostics received an FDA warning letter after an investigator saw employees assembling a drugs of abuse test panel and an amphetamine test strip on the same table. Read More
Irish devicemaker Covidien is voluntarily recalling certain lots of its Pipeline Embolization Device and Alligator Retrieval Device over concerns a coating applied to the delivery wire could detach from the devices. Read More
As the clock ticks down for high-risk devices to comply with the FDA’s unique device identifier rule, the first organization accredited to issue UDIs is offering devicemakers some advice. Read More
Manufacturers should update their medical device tracking procedures to account for unique device identifiers, the FDA says in updated guidance. Read More
The FDA may approve devices whose benefit-to-risk ratio is less certain if that uncertainty is “sufficiently balanced” by other factors such as postmarket controls, the agency says in draft guidance published Wednesday. Read More
Overall reports of adverse events declined over the past three years from 21,729 in 2011 to 14,819 in 2013, according to data published by the UK’s Medicines and Healthcare products Regulatory Agency. Read More
Snoqualmie, Wash., devicemaker Spacelabs Healthcare sent an Urgent Medical Device Correction letter to customers March 11, warning of a defect in the version 2.0 software accompanying its Arkon anesthesia delivery system. Read More
Laparoscopic devices commonly used to treat uterine fibroids could spread cancerous tissue, the FDA said Thursday in a safety communication discouraging the use of the procedure. Read More