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After almost a decade devoted to implementing unique device identifier (UDI) regulations, the FDA is now focused on enforcing them, says UDI expert Jay Crowley, a former FDA official who played a key role in crafting the U.S. regulations. Read More
A company-initiated recall of nearly 68,000 Olympus bronchoscopes is now deemed class I by the FDA because of the risk of endobronchial combustion, which could cause serious injuries or death. Read More
Upcoming events in the coming weeks and months include three FDA advisory committee meetings; MAGI 2024: The Clinical Research Conference; and webinars on medical device cybersecurity, overcoming common clinical trial challenges and FDA inspections. Read More
Stolen defective laryngoscopes offered for sale on Facebook Marketplace are now part of a manufacturer recall the FDA has deemed as class I, the most serious type of recall as use of the device could result in injuries or death. Read More
After 19 pilot programs conducted with medical device companies, regulators and patient communities, CDRH’s revised CAPA process is showing a 60 percent closure rate in under 60 days and a 50 percent overall reduction in improvement timelines, say FDA officials. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
In this edition of Quick Notes we tackle regulatory activity across the pond in Britain and the EU with stories on increased EMA fees, electronic product information for medicines, an updated service to help pharmaceutical companies and repurposing of a drug to help prevent breast cancer. Read More
The COVID-19 public health emergency may be officially over, but the temporary changes it provoked in regulatory assessments are here to stay, experts said during the 18th Annual FDA Inspections Summit last week. Read More
Over the past week, the FDA issued final guidance on real-time oncology review and cosmetic product facility registration and product listing. Read More