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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR812.66]
See Related Information on Significant risk device determinations. in CDRH databases



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

Sec. 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]

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