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22. 06.2017

New FDA guidance explains electronic record requirements for medical device clinical trials

US Food and Drug Administration medical device regulators have published new draft guidance recommending proper use of electronic records and signatures in clinical investigations. The new guidance applies to clinical trial sponsors and investigators as well as Institutional Review Boards (IRB) and clinical research organizations (CRO) that must comply with 21 CFR Part 11 regulations pertaining to electronic records and signatures.