Food and Drug Administration response to Department of Energy's request for clarification of the circumstances under which...
Office of Environment, Health, Safety & Security
September 6, 2012
minute read time
September 6, 2012
Food and Drug Administration response to Department of Energy's request for clarification of the circumstances under which a DOE Government Owned Contractor Operated (GOCO) facility may be considered a laser manufacturer and subject to FDA laser manufacturer requirements and other points of interpretation of the FDA Exemption Letter, 78EL-01DOE (DOE exemption or exemption) by the LSSG for GOCG facilities.