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Devicemakers whose instructions for use are flawed or poorly written could see them flagged by the UK’s Medicines and Healthcare products Regulatory Agency as adverse events. Read More
The EU was set to sign on as a full observer to the International Medical Device Regulators Forum’s single audit program when the group met in Tokyo in late March, according to an FDA official familiar with the talks. Read More
The U.S. FDA has chosen a veteran public health officer to spearhead its device postmarket surveillance programs. Gregory Pappas joined the agency in February as associate director for national device surveillance in the Center for Devices and Radiological Health’s Office of Surveillance and Biometrics.
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Women’s healthcare device manufacturer CooperSurgical received a Form 483 for failure to initiate corrective action for a process failure associated with its Blunt Hurd Cannula-Blunt Tip 10mm with 5mm Reducer. Read More
The U.S. FDA will roll out a simplified adverse event reporting form this spring in hopes of getting more consumers to use its MedWatch system, agency officials said. Read More
Lack of progress on medical device reform legislation has spurred some EU countries to use last year’s joint immediate action plan to improve device oversight. Read More
The number of medical devices recalled in the U.S. during the final quarter of 2014 increased over the previous quarter despite an overall drop in the number of recall actions, a report from Stericycle Expert Solutions shows. Read More
Indian devicemakers and governmental and nongovernmental partners have formed a steering committee to push forth a self-certification scheme for industry manufacturing best practices. The aim is to ensure the quality of Indian devices and eliminate sales of substandard products. Read More
U.S. and European diabetes groups are recommending that an international registry be established to gather reports on insulin pump safety, citing lax EU device regulations that leave patients at risk. Read More