The FDA issued draft guidance to clarify radiation control regulations for diagnostic x-ray systems and their major components, including recordkeeping, reporting, manufacturing, importing and installation requirements for “electronic pr... Read More
Australia’s Therapeutic Goods Administration is reviewing how it regulates software as a medical device (SaMD) and has issued guidance on its latest thinking. Read More
The FDA issued final guidance on user fees and refunds for device biologics license and premarket approval applications with just minor changes from the October 2017 draft. Read More
FDA Commissioner Scott Gottlieb said the agency plans to release more details in the coming weeks about its precertification program for digital health technology, including details of the agency’s testing plan for products in 2019. Read More
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