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Devicemakers that suffer a cybersecurity breach should let the public know as soon as possible, in a way that makes the disclosure easy to find, the FDA said. Read More
After three years, the FDA has published the final version of its proposed rule on De Novo device classification, which offers a pathway for marketing authorization for new Class I and Class II De Novo devices instead of automatically designating them as high-risk Class III devices. Read More
There is a higher than expected risk of the polyethylene component of Stryker’s Scandinavial total ankle replacement (STAR) devices breaking as early as three to four years after implantation, the FDA said in an update on a post-approval study. Read More
Siemens has received an FDA contract worth $1.78 million for computer technology related to medical devices, as part of the agency’s efforts to promote advanced manufacturing. Read More
The European Union is far from ready for full implementation of its In Vitro Diagnostic Regulation (IVDR) by the May 26, 2022, deadline for certification of products, said an official of Europe’s main device trade association. Read More
The sponsor of a device study “is generally better positioned than the individual investigator” to assess unanticipated adverse device effects, the FDA said in a new guidance. Read More
Device trade group AdvaMed has filed an amicus brief in the California Court of Appeal backing Johnson & Johnson’s (J&J) appeal of the $344 million verdict against the company early last year for allegedly deceiving consumers about its pelvic mesh products. Read More
The recall of millions of Philips Respironics continuous positive airway pressure (CPAP) devices for treatment of sleep apnea continues to impact activities that would not automatically come to mind, such as commercial trucking. Read More
The FDA’s Center for Devices and Radiologic Health (CDRH) seems to have gotten bogged down in its efforts to meet its commitments under the fourth iteration of the Medical Device User Fee and Modernization Act (MDUFA IV), according to the consultancy Booz Allen Hamilton. Read More
Eudamed, the European database on medical devices, will be offline for several days to allow for a “major upgrade” as new functions are about to come online, the European Commission said. Read More
The FDA’s current system of device approvals is letting serious safety problems slip through the cracks, suggests an editorial in the American Medical Association’s Journal of Ethics. Read More