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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.

FDA should allow device industry experts to participate in its new “network of experts” program for tapping outside expertise when novel scientific issues arise, industry trade groups argue.

The agency floated draft policies Oct. 4 for establishing a network of experts to provide additional scientific, engineering and medical expertise to supplement the device center’s own know-how as needed....

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