21 CFR § 812.66 - Significant risk device determinations.

---
identifier: "/us/cfr/t21/s812.66"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 812.66 - Significant risk device determinations."
title_number: 21
title_name: "Food and Drugs"
section_number: "812.66"
section_name: "Significant risk device determinations."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "812"
part_name: "INVESTIGATIONAL DEVICE EXEMPTIONS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 360hh-360pp, 360rr-360ss, 360bbb-8b, 371, 372, 374, 379e, 381, 382; 42 U.S.C. 216, 241, 262."
regulatory_source: "45 FR 3751, Jan. 18, 1980, unless otherwise noted."
cfr_part: "812"
---


# 812.66 Significant risk device determinations.

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).

[46 FR 8957, Jan. 27, 1981]