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Bone Conduction Hearing System into Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies the active implantable bone conduction hearing system into Class 2 (special controls).

Class 2 for Humidified Oxygen Delivery Devices

[ Price : $8.95]

Federal Register notice: FDA classifies high-flow humidified oxygen delivery devices into Class 2 (special controls).

Rebinyn Regulatory Review Period Determined

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Novo Nordisks Rebin...

Align Technology Gains Clearance for Revised Invisalign

[ Price : $8.95]

FDA clears an Align Technology 510(k) for the Invisalign treatment with mandibular advancement, a clear aligner solution for Class...

Research Mulls Approach to Qualify Patient-reported Measures

[ Price : $8.95]

New research supported by CDRHs Division of Biostatistics outlines an approach that could lead to more patient-reported outcome me...

Circulatory System Device Panel to Meet 12/4-5

[ Price : $8.95]

Federal Register notice: FDA announces a12/4-5 Circulatory System Devices Panel of the Medical Devices Advisory Committee.

Abbott/AbbVie Pay $25 Million in Off-Label Case

[ Price : $8.95]

Abbott Laboratories and its spin-off AbbVie agree to pay $25 million to resolve allegations that they used kickbacks and off-label...

Dangerous, Unethical Tests at Minn. Medical Center: Public Citizen

[ Price : $8.95]

FDA inspects a Minnesota medical center and finds violations that subjected unwitting patients to dangerous and unethical human te...

FDA Approves Jazz Pharmas Xyrem for Pediatric Cataplexy

[ Price : $8.95]

FDA approves a Jazz Pharmaceuticals supplemental NDA to revise labeling for Xyrem (sodium oxybate) oral solution to include an ind...

Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 10/26/2018.