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FDA Updates Medical Device Shortages List | Knobbe Martens

The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and. ....

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FDA Releases Guidance On Submissions For Ai/Ml-Enabled Devices - Life Sciences, Biotechnology & Nanotechnology

On April 3, 2023, the Food and Drug Administration (FDA) published in the Federal Register an announcement of availability for the draft guidance, Marketing Submission Recommendation. ....

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FDA Releases Guidance on Submissions for AI/ML-Enabled Devices | Foley Hoag LLP

On April 3, 2023, the Food and Drug Administration (FDA) published in the Federal Register an announcement of availability for the draft guidance, Marketing Submission Recommendations. ....

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FDA Issues Radiation Sterilization Update for PMA Holders

The FDA is considering a master file pilot program for premarket approval holders whose approved devices are sterilized using radiation, including gamma radiation. ....

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Are You A Medical Device Servicer Or Remanufacturer? FDA's New Guidance May Help…Or Not - Food, Drugs, Healthcare, Life Sciences

Are You A Medical Device Servicer Or Remanufacturer? FDA's New Guidance May Help…Or Not - Food, Drugs, Healthcare, Life Sciences
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