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21 CFR 812.45

§ 812.45 Informing investigators.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 812.45, § 812.45 Informing investigators, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88830
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Full text

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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.