The Premarket Approval (PMA) pathway is complex. The PMA application needs to provide a reasonable assurance that the device is safe and effective for its intended use (21 USC 360e(d)(1)(A)).
Premarket Approval (PMA) Agreement with FDA for the Medical Device Companies
10 - 11 April 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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GlobalCompliancePanel
Contact information
Mr John Robinson
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA, Fremont, 94539, United States of America
8004479407
Contact us by email
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA, Fremont, 94539, United States of America
8004479407
Contact us by email
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