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The FDA is planning to exempt certain unclassified devices from premarket notification requirements, according to an updated guidance from the agency. Read More
Australia’s Therapeutic Goods Administration issued two new guidances, one proposing a regulatory framework for personalized medical devices and the other on regulation of software, including software as a medical device (SaMD). 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 the European Commission. Read More
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AdvaMed said the tax should be repealed so the industry can “make the multi-year investments in R&D and infrastructure necessary to sustain the innovation ecosystem.”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