This article was originally published in The Gray Sheet
Executive SummaryFDA would have a one-year transition period to coordinate in-vitro diagnostic complexity categorization with the agency's existing 510(k) review process under the current proposal pending approval by the FDA commissioner's office that would return CLIA categorization authority to FDA from the Centers for Disease Control and Prevention, staffers say. FDA is expected to sign off on the proposal imminently; HHS must also provide authorization before any transfer of authority can occur. Heading up the categorization program at FDA will be Joseph Hackett, coordinator of the premarket approval program at the device center's Division of Clinical Laboratory Devices
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