---
kind: "section"
citation: "21 C.F.R. § 812.66"
title: "21"
number: "812.66"
heading: "Significant risk device determinations."
url: "https://uscodex.org/cfr/21/812.66"
---

# §812.66. Significant risk device determinations.


If an IRB determines that an investigation, presented for approval under [§ 812.2(b)(1)(ii)](/cfr/21/812.2.md?p=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)](/cfr/21/812.30.md?p=a).


## Notes

### Amendments

[46 FR 8957, Jan. 27, 1981]

### Authority

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.

### Source

Source: 45 FR 3751, Jan. 18, 1980, unless otherwise noted.

### Amendments

[46 FR 8957, Jan. 27, 1981]