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FDA Expands Network Of Experts After Successful Pilot

This article was originally published in The Gray Sheet

Executive Summary

The Network of Experts, which connects CDRH scientists with outside professional societies, has been made a permanent program within the device center.

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The American College of Cardiology, the Society of Thoracic Surgeons and the American Institute for Medical and Biological Engineering have each agreed to lend the knowledge of their members to the device center’s pilot program for tapping outside expertise.

Device Makers Want A Spot In FDA’s New “Network Of Experts”

Device industry players argue FDA should expand its vision of the new network-of-experts program to include industry experts who may understand new technologies best. They also raise concerns about confidentiality protection and review delays in public comments to the agency on the new initiative.

CDRH Has New Plan For Tapping Outside Science Experts

FDA’s device center is in talks with several professional societies and hopes to have its first agreement in place within the month for a pilot program that would allow CDRH to tap outside expertise when pressing scientific questions arise.

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