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FDA Launches Digital Health Center of Excellence

[ Price : $8.95]

FDA says it is launching a Digital Health Center of Excellence within CDRH.

Spineology Gains De Novo for OptiMesh

[ Price : $8.95]

FDA grants Spineology Inc. a de novo marketing authorization for its OptiMesh Expandable Interbody Fusion System.

Q&A Content Added to Clinical Trial Guidance

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FDA adds content to a question-and-answer appendix in its guidance entitled Conduct of Clinical Trials of Medical Products during ...

FDA Labeling Policies Blamed for IUD Damage to Women

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Years of complaints about the adequacy of CDRH device labeling requirements are echoed in a new raft of complaints about the safet...

Replacement Guidance on Covid-19 Convalescent Plasma

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Federal Register notice: FDA makes available a replacement final guidance entitled Investigational Covid-19 Convalescent Plasma.

Obsolete Covid-19 Plasma Guidance Withdrawn

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Federal Register notice: FDA withdraws a May-issued final guidance entitled Investigational COVID19 Convalescent Plasma because th...

HHS Power Grab is Distraction to FDA: Gottlieb

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Former FDA commissioner Scott Gottlieb criticizes a recent move by HHS to redirect its authority to prevent FDA and other health a...

Simplify Medical Artificial Disc Approved

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FDA approves a Simplify Medical PMA for its Simplify Artificial Disc for one-level disc replacement indications.

FDA Classifies 4 Recent BD Alaris Pump Recalls

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Becton, Dickinson says four previously announced recalls of its BD Alaris System have been classified as Class 1 for three events ...

CDRH Updates MAUDE Adverse Events Database

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CDRH updates its public Manufacturer and User Facility Device Experience database to improve transparency and analysis of medical ...