FDA: Consent Needed for All Biospecimens in Device Studies

Device studies that use leftover biospecimens or samples that have been stripped of their identifying information are still subject to the FDA’s informed consent requirements, the agency clarified in an information collection notice published in the Oct. 23 Federal Register (80 Fed. Reg. 64,422).

The clarification and request for comment makes a distinction between the Food and Drug Administration’s human subject protection regulations (21 C.F.R. Part 50) and the Department of Health and Human Services’ corresponding regulations known as the Common Rule (45 C.F.R. Part 46). Under the Common Rule, biospecimens ...