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The FDA’s 9-member Patient Engagement Advisory Committee (PEAC) met yesterday in a public meeting to discuss how devicemakers and the FDA can better share information during recalls. Read More
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