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The Medical Imaging & Technology Alliance is calling on the FDA to establish a framework that distinguishes between servicing and remanufacturing activities for medical imaging devices. Read More
AdvaMed said the tax should be repealed so the industry can “make the multi-year investments in R&D and infrastructure necessary to sustain the innovation ecosystem.” Read More
The TGA noted the increasing use of 3D printing for medical applications was raising concerns about the adequacy of the current regulatory framework. Read More
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