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CDRH Creates Web Page on Post-Approval Device Studies

CDRH has debuted a Web site that will keep the public informed about the status of studies mandated by the center as a condition of approval for certain medical devices. It will include all post-approval studies ordered by CDRH since Jan. 1, 2005.

Transforming FDA LogoCDRH has debuted a Web site that will keep the public informed about the status of studies mandated by the center as a condition of approval for certain medical devices. It will include all post-approval studies ordered by CDRH since Jan. 1, 2005. It is based on information reported by firms, who are required to update the center every six months during the first two years of a study, and every year thereafter. Each listing includes the company's name, the product's name, the approval number and date, and describes the study and whether it is meeting its reporting deadlines. Detailed information on clinical data is not included because of privacy and other issues. The site, which can be viewed here, was first suggested by the Institute of Medicine in 2005, and is long overdue.
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