CLIA Transfer
This article was originally published in The Gray Sheet
Executive Summary
Transfer of responsibility for the categorization of commercially marketed in vitro diagnostic (IVD) tests under the Clinical Laboratory Improvement Amendments of 1988 from the Centers for Disease Control and Prevention to FDA is under way, according to a Dec. 30 Federal Register notice. The transfer will permit IVD manufacturers to submit premarket applications and requests for complexity categorizations for the products to one agency. CDC and FDA expect the transfer to be complete by Jan. 31. Until that time, categorization requests should continue to be submitted to CDC