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510(k) Pilot for Optical Coherence Tomography Devices

[ Price : $8.95]

FDA announces a voluntary Optical Coherence Tomography Premarket Notification (510(k)) Pilot Program, which is intended to develop...

New Use Cleared for Levita Magnetic Surgical Device

[ Price : $8.95]

FDA clears a Levita Magnetics 510(k) for an expanded indication to market the companys Levita Magnetic Surgical System for use in ...

Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 10/19/2018.

Quantitative Efficacy/Risk Info in DTC Ads

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Presenting Quantitative Efficacy and Risk Information in Di...

Updated Safety Communication on Heater-Cooler Devices

[ Price : $8.95]

FDA updates a safety communication to reduce potential cardiac surgery infection risks associated with the LivaNova 3T Heater-Cool...

Regulatory Review Period for SK Chemicals Afstyla

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for SK Chemicals Afstyl...

Regulatory Review Period for Regenerons Dupixent

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Regeneron Pharmaceu...

6 Medical Device Classification Orders Posted

[ Price : $8.95]

Federal Register notices: FDA makes available six medical device classification orders.

Abbott HeartMate 3 OKd for Advanced Heart Failure

[ Price : $8.95]

FDA approves Abbotts HeartMate 3 Left Ventricular Assist Device as a destination therapy for people living with advanced heart fai...

Warning Letter to Ocular Therapeutix Over Post-Approval Study

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FDA issues Ocular Therapeutix a 10/17 Warning Letter over the companys compliance with data collection and information reporting o...