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The new regulations will apply to any marketing authorization application for a medicinal product with an integral medical device submitted as of May 26, 2020. Read More
AdvaMed said it’s worried that sponsors, sites or researchers may still be on the hook for privacy waivers under the Health Insurance Portability and Accountability Act. Read More
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