Code of Federal Regulations · Section
§ 812.45 — Informing Investigators
21 C.F.R. § 812.45
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A sponsor shall supply all investigators participating in the investigation with copies of the investigational plan and the report of prior investigations of the device.
Authorizing Statute
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Regulations42 U.S.C. § 216
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Prohibited acts21 U.S.C. § 331