{"data":{"id":"us/21-cfr-812.66","jurisdiction":"us","citation":"21 CFR 812.66","heading":"Significant risk device determinations.","body":"If an IRB determines that an investigation, presented for approval under § 812.2(b)(1)(ii), involves a significant risk device, it shall so notify the investigator and, where appropriate, the sponsor. A sponsor may not begin the investigation except as provided in § 812.30(a).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS","Subpart D—IRB Review and Approval"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"8dc5878c70d1322f65b17be05fbc0bad0089af339fd6a0928020a494601be837","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-812.65","next":"us/21-cfr-812.100"},"notice":"GroundRules: Original legal text. Not legal advice."}