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Electronic Code of Federal Regulations

e-CFR data is current as of November 18, 2019

Title 21Chapter ISubchapter HPart 812Subpart C → §812.42


Title 21: Food and Drugs
PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS
Subpart C—Responsibilities of Sponsors


§812.42   FDA and IRB approval.

A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both approved the application or supplemental application relating to the investigation or part of an investigation.

[46 FR 8957, Jan. 27, 1981]

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