What I am about to share with you is a guide to medical device regulatory classification. In this guide, I will provide you with a step-by-step approach for determining how your medical device will be ...
Medical Device Network on MSN
FDA scraps ‘Final Rule’ classifying LDTs as medical devices
The FDA’s move to nix its ‘Final Rule’ comes in response to the legislation’s strike down in a Texas court in March 2025.
PHILADELPHIA, Jan. 04, 2022 (GLOBE NEWSWIRE) -- AnPac Bio-Medical Science Co., Ltd. (“AnPac Bio,” the “Company” or “we”) (ANPC), a US and China-based biotechnology company focused on early cancer ...
The FDA is excluding eight software functions that were previously classified as medical device status under the 21st Century Cures Act. The FDA released the new provisions in an April 19 document in ...
Dublin, Aug. 24, 2020 (GLOBE NEWSWIRE) -- The "Medical Device Market by Device Type, Function, Durability, Therapeutic Segment, Risk Classification, Manufacture Method, Delivery/Acquisition, ...
PHILADELPHIA, Jan. 04, 2022 (GLOBE NEWSWIRE) -- AnPac Bio-Medical Science Co., Ltd. (“AnPac Bio,” the “Company” or “we”) (ANPC), a US and China-based biotechnology company focused on early cancer ...
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