The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.
By Stewart Eisenhart, Emergo Group
New draft guidance from the US Food and Drug Administration proposes Good Clinical Practice (GCP) compliance for accepting medical device clinical data from studies conducted in foreign countries, and also outlines criteria the agency uses for accepting such data as part of medical device premarket registration submissions.
from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1PpEI7O
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