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FDA Schedules GDUFA Reauthorization Public Meeting

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FDA says commissioner Stephen Hahn will kick off a 7/21 virtual public meeting on GDUFA 3 reauthorization.

CME America Updates Recalled BodyGuard Tests

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FDA reports on additional flow-rate accuracy conducted by CME America on its recalled BodyGuard infusion system administration set...

Medical Device Electronic Format Guidance

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FDA issues a guidance on electronic formats for medical device regulatory submissions.

EUA Revoked on Chembio Covid-19 Test

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Federal Register notice: FDA announces the revocation of an Emergency Use Authorization issued to Chembio Diagnostic Systems for t...

Draft Guide on BPH Device Updates

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Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Guidance for the Non-Clinical and Clinic...

FDA Backs Revised E-submission Standards

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Federal Register notice: FDA announces its support for the current version of Clinical Data Interchange Standards Consortium Stand...

Prostate Tissue Ablation Device Guidance

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FDA issues a guidance recommending ways to comply with the clinical testing special control for 510(k)s for prostate ablation high...

FDA Posts EUAs for Covid

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Federal Register notice: FDA makes information available on the issuance and reissuance of Emergency Use Authorizations for certai...

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company Kegan Wellness.

CTAP Has Reviewed Over 230 Covid Trials: Hahn

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FDA commissioner Stephen Hahn says in a CTAP update that FDA has reviewed over 230 trials for Covid therapeutics.