FDA Offers Framework For Assessing Credibility Of Devices Designed With Computational Modeling And Simulation
The US FDA has issued draft guidance to help manufacturers substantiate the credibility of computational modeling and simulation used in submitting their medical devices to the agency for premarket approval. The agency says deficiencies in analytical methods for evaluating CM&S hampers its use in supporting regulatory submissions.
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The US FDA has stopped publishing its list of approvals and denials of premarket approval applications (PMAs) and humanitarian device exemptions (HDEs) in the Federal Register on a quarterly basis. The agency says the change will save money and resources.
Biden Pledges A Billion COVID-19 Tests, Announces Plan Requiring Private Insurers To Pay For At-Home Diagnostics
The Biden administration announced on 13 January that it’s purchasing an additional 500 million COVID-19 tests to be distributed free to any American wanting one, bringing the total to 1 billion tests procured.