Jordan Gottdank

Jordan Gottdank

Knobbe Martens

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FDA Announces International Draft Guidance for Clinical Evaluation of Software as a Medical Device

The U.S. Food and Drug Administration announced the availability of a draft guidance for the clinical evaluation of software as a medical device (SaMD). The draft guidance was prepared by the SaMD Working Group of the...more

11/15/2016  /  Clinical Evaluations , Draft Guidance , Food and Drug Administration (FDA) , International Medical Device Regulators Forum (IMDRF) , Medical Devices , Proposed Guidance , Public Comment , Software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