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Latest Posts › Food and Drug Administration (FDA)

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FDA Announces Innovation Challenge for Devices to Prevent and Treat Opioid Use Disorder

The Food and Drug Administration (FDA) has announced a medical device innovation challenge to help address opioid abuse and misuse. With the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder, the FDA...more

7/25/2018 / Drug & Alcohol Abuse , Food and Drug Administration (FDA) , Innovative Technology , Medical Devices , Opioid

Speedboat RS2 Endoscopic Device Receives FDA Clearance

UK-based Creo Medical recently announced the clearance of its Speedboat RS2 surgical endoscopic device for minimally invasive removal of lesions in the bowel....more

9/13/2017 / Cancer , Expedited FDA Approval , Food and Drug Administration (FDA) , Medical Devices

FDA Announces International Draft Guidance for Clinical Evaluation of Software as a Medical Device

The U.S. Food and Drug Administration announced the availability of a draft guidance for the clinical evaluation of software as a medical device (SaMD). The draft guidance was prepared by the SaMD Working Group of the...more

11/15/2016 / Clinical Evaluations , Draft Guidance , Food and Drug Administration (FDA) , International Medical Device Regulators Forum (IMDRF) , Medical Devices , Proposed Guidance , Public Comment , Software

FDA Proposes Ban on Electrical Stimulation Devices for Aggressive or Self-Injurious Behavior

On April 25, the U.S. Food and Drug Administration published a proposed rule banning electrical stimulation devices (ESDs) used to treat aggressive or self-injurious behavior....more

4/29/2016 / FDA Device Bans , Food and Drug Administration (FDA) , Medical Devices , Proposed Regulation , Public Comment , Public Health , Public Safety

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