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CDRH Pioritized Guidance Listing for FY 2021

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CDRH posts a list of prioritized guidance documents that it intends to publish during fiscal year 2021.

Quality Management Pilot for Finished Drugs

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Federal Register notice: FDA announces its Quality Management Maturity for Finished Dosage Forms Pilot Program for domestic drug p...

CDRH Posts Videos of Device User Fee Accomplishments

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CDRH posts a series of videos highlighting the progress the Center has made to date with implementing the current medical device u...

Guide on Nitinol Device Non-Clinical Assessments

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Federal Register notice: FDA makes available a final guidance entitled Technical Considerations for Non-Clinical Assessment of Med...

Guide on Device Biocompatibility Info in Submissions

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Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Biocompatibility of Certain Devices in C...

Many AI/ML Framework Comments Lack Evidence: Study

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University of Oxford researchers find that many comments on an FDA framework for modifying artificial intelligence and machine lea...

See-Mode Tech AI Cleared for Vascular Scans

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FDA clears a See-Mode Technologies 510(k) for its Augmented Vascular Analysis, a medical artificial intelligence software for auto...

AstraZeneca Vaccine Safety Info Slow Coming to FDA: Report

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An anonymous source tells CNN that AstraZeneca took several weeks to deliver data to FDA on the Covid vaccine trial participant il...

FDA Hides Product Names in Serious CAERS Reports: Survey

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Consumer Reports says FDA has been inappropriately redacting product names from some dietary supplement adverse event reports cove...

Merit Medical Paying $18 Million to Resolve Kickback Case

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The Justice Department says Merit Medical Systems will pay $18 million to resolve a whistleblower complaint that it paid advertisi...