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Just over a quarter of adverse incidents reported by devicemakers to the UK’s Medicines and Healthcare products Regulatory Agency in 2012 were submitted online, compared with nearly 90 percent of user-generated reports, the agency says. Read More
Devicemakers should take steps now to secure a production account for submitting electronic Medical Device Reports, ahead of an Aug. 14, 2015 deadline for compliance with mandatory eMDRs. Read More
Thousands of liability claims alleging the NuvaRing combination product contraceptive causes potentially fatal venous thromboembolisms are set to be settled with a $100 million Merck payout. Read More
CDRH plans to reduce the number of IDEs requiring more than two cycles to make a determination by 25 percent by Sept. 30, and by 50 percent by June 30, 2015. The aim is to get the median time for full IDE approvals down to 30 days by June 30, 2015. Read More
New device registries should only be launched if they are the least burdensome way to meet scientific objectives, AdvaMed says in a revised document on registry principles released Tuesday. Read More
Devicemakers should note whether changes to PMA devices were due to enhancement, product complaints or adverse events when preparing annual reports for the FDA, new guidance released Friday says. Read More
The FDA is under fire from a prominent House Democrat for pushing devices through accelerated approval pathways based on limited data, a practice she says could be endangering patients. Read More
Medical device companies must include all core data elements for the unique device identification database except those marked “optional,” according to the International Medical Device Regulators Forum. Data elements marked “if applicable” are mandatory in the UDID if the information appears on the product label, IMDRF adds. Read More