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The FDA is not likely to give an IDE to trials involving patients with histories of seizure, intellectual impairment, clinically relevant memory problems, psychosis or a chronic psychiatric disorder. Read More
The agency would allow healthcare providers to produce lower-risk personalized devices for patients without the need for manufacturing certification. Read More
Recalls may involve defect corrections, hazard alerts for implanted devices with deficiencies, or taking the device permanently off the market. Read More
The bipartisan sponsors called on fellow members to support or co-sponsor the Protect Medical Innovation Act of 2019, which would permanently repeal the tax. Read More
BSI said that when it initiated its contingency plan in August 2016, it “could not have foreseen the lack of political progress” toward a Brexit resolution. Read More
The U.S. and the EU have pledged to cooperate to ensure that electronic database specifications for unique device identifiers (UDIs) are in alignment, according to a report by the European Commission. Read More
Australia’s Therapeutic Goods Administration has implemented new recall procedures that clarify when to quarantine products as well as how to communicate information about recalls. Read More