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Devicemakers scrambling to classify or reclassify their products under the EU’s Medical Devices Regulation (MDR) now have some help in the form of a new guidance. Read More
The FDA is reclassifying some surgical staplers for internal use from lower-risk Class I devices to higher-risk Class II devices that require premarket reviews. Read More
The Centers for Medicare & Medicaid Services (CMS) proposes to withdraw the Medicare Coverage of Innovative Technology (MCIT) final rule that is scheduled to go into effect on Dec. 15 and is pondering suggestions from the public about what should go in its place. Read More
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