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Regulatory Brief

An overview of 21 CFR Part 812: Investigational Device Exemptions (IDEs)

21 CFR Part 812 is the U.S. federal regulation that addresses investigational device exemptions that allow medical devices to be used in a clinical study prior to obtaining market clearance. Read our free regulatory brief for an overview of the regulation and where it is applicable.

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An overview of 21 CFR Part 812: Investigational Device Exemptions (IDEs)

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