CDRH Proposes Increased Transparency For Device Postapproval Studies
This article was originally published in The Gray Sheet
Executive Summary
FDA plans to establish a website for tracking device postapproval studies
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Regulatory News In Brief
Postapproval study penalties: The Office of Surveillance & Biometrics may enforce civil money penalties when manufacturers fail to conduct condition of approval (CoA) studies, OSB Director Susan Gardner warns at an FDA Gastroenterology & Urology Device Panel meeting in Gaithersburg, Md., June 8. The device would be labeled as misbranded, she stressed. Gardner further noted that an automated OSB tracking system of CoA commitments is operational and the status of postmarket studies will be made available publicly on CDRH's website (1"The Gray Sheet" Oct. 25, 2004, p. 10). FDA and AdvaMed reps plan to meet June 21 to discuss challenges to meeting postmarket pledges...
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