Zdrowie i gospodarka · 26/01/2018

FDA Extends Comment Period for Draft Guidance on CLIA Waiver Applications for In Vitro Diagnostic Devices

The Food and Drug Administration (FDA) is extending the comment period for draft guidance on Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver applications for manufacturers of in vitro diagnostic devices, in response to a request for an extension, following the notice of availability published in the Federal Register on November 29, 2017.