Zdrowie i gospodarka · 24/06/2011

FDA Confirms Exception for Investigational Diagnostic Devices to Identify Chemical, Biological, Radiological, or Nuclear Agents

The FDA is issuing a final regulation confirming an exception from general informed consent requirements for the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents. This exception aims to facilitate timely use of diagnostic devices for individuals exposed to such agents, with the added requirement of submitting documentation to both FDA and the Institutional Review Board.