Common Rule Essentials for FDA CDRH Group
FDA Center for Devices and Radiological Health (CDRH) Office of Science and Engineering Laboratories (OSEA) · November 13, 2025
OHRP senior staff Yvonne Lau briefed FDA CDRH OSEA staff on the Revised Common Rule, focusing on definitions of ‘‘research’’ and ‘‘human subjects,’’ exemptions (notably exemptions 2 and 4), the public-health-surveillance carve-out, limited IRB review, federal-wide assurances and how these rules commonly apply to CDRH-funded activities. Staff asked about FDA–OHRP harmonization and where to direct follow-up questions.
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