Guidance on Informed Consent of in Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable
Rockville, MD: U.S. Food and Drug Administration [FDA], 2006 April 25; 10 p. [Online]. Accessed: http://www.fda.gov/cdrh/oivd/guidance/1588.pdf [2006 May 3]
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United States. Food and Drug Administration [FDA]. Center for Devices and Radiological Health. Office of In Vitro Diagnostic Device Evaluation and SafetyCenter for Biologic Evaluation and Research. Office of Blood Research and Review
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