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Internal Therapeutic Massagers Put Into Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies internal therapeutic massagers into Class 2 (special controls).

FDAs Growing Concern on Device Sterilization

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FDA grows concerned over recent closures of certain large-scale sterilization facilities that use ethylene oxide to sterilize medi...

Impella Heart Pump Study Confirms Survival Data

[ Price : $8.95]

Abiomed says that a post-approval study confirmed survival data in its pre-approval study for the Impella RP heart pump.

Five Class 2 Devices Exempt from 510(k)

[ Price : $8.95]

Federal Register notice: FDA announces its decision to exempt a list of Class 2 devices from premarket notification requirements.

Draft Guide on Postmarketing Studies/Trials

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Postmarketing Studies and Clinical Trials Implementation o...

Device Recognized Standards List Modified

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Federal Register notice: FDA makes available its listing of Modifications to the List of Recognized Standards, Recognition List Nu...

Draft Guide on Breast Implant Labeling

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Federal Register notice: FDA makes available a draft guidance entitled Breast Implants Certain Labeling Recommendations to Improv...

Publicly Supported Drug Research Plays Valuable Role: Study

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Harvard Medical School researchers say publicly supported research helped at least 25% of all drugs approved by FDA between 2008 a...

Sharpless Credits FDA 2019 Opioid Actions

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FDA acting commissioner Ned Sharpless reviews agency steps in 2019 to combat the opioid crisis by implementing the SUPPORT Act.

FDA Releases New Ranitidine Contamination Test

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FDA releases a second method for evaluating presence of NDMA in ranitidine drug products.