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This article was originally published in The Gray Sheet
CoA guidance: CDRH draft guidance on condition-of-approval study reports clears FDA's Office of Chief Counsel vetting process and should be released shortly, according to an Office of Surveillance and Biometrics staffer. Responsibility for tracking and reviewing CoA studies was transferred to OSB from the Office of Device Evaluation in January (1"The Gray Sheet, April 11, 2005, p. 8)...
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