Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.
Managing the IDE (Investigational Device Exemption) Submission for Compliance Success
8 July 2014, Fremont, United States
Introduction
Venue
Online Event
Online Event, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA, Fremont, 94539, United States
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Organised by
GlobalCompliancePanel
Contact information
Mr John Robinson
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA, Fremont, 94539, United Kingdom
08004479407
Contact us by email
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA, Fremont, 94539, United Kingdom
08004479407
Contact us by email
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