Institute Of Medicine Circulates Draft 510(k) Report For Peer Review

Article preview from "The Gray Sheet"- April 11, 2011

The Institute of Medicine committee that is reviewing FDA's 510(k) program has completed a draft report and circulated it among a select group, including industry, for peer review.

Institute Of Medicine Circulates Draft 510(k) Report For Peer Review

Article preview from "The Gray Sheet"- April 11, 2011

The Institute of Medicine committee that is reviewing FDA's 510(k) program has completed a draft report and circulated it among a select group, including industry, for peer review.


"It's quite similar to what happens when a scientific or medical paper is submitted to a journal," explained IOM spokeswoman Christine Stencel. "There are individuals who review the draft and come back with their comments to the committee," she told “The Gray Sheet” in an interview.

More than a dozen people are involved in the peer review, IOM said.

"It's a means of ensuring that what the committee has put in the report, their conclusions and recommendations, are grounded in solid information," she noted.

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