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Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (g)

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Document information
Reference USA 21 CFR Part 812 09-Apr-2025
Validity area USA
Scope(s) MD
Document name 21 CFR Part 812
Version / Revision 09-Apr-2025
Status Current
Document type Legal act
Language(s) EN
Description 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 https://www.ecfr.gov/current/title-21

Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details
Module Module 3 — Unit 3.4.2
Scope MD
Document part § 812.3

(g)

Language EN
Original entry by Florian Adragna
Contributors
Tags Investigational device, Definition, Medical device

Content

(g) Investigational device means a device, including a transitional device, that is the object of an investigation.