Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart B

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 1 — Unit 1.5.4
Scope	MD
Document part	Subpart B
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Regulatory submission, Requirements, Medical device, Investigational device
Comment	IDE application: submission and content requirements

Content

Subpart B—Application and Administrative Action § 812.20 Application. (a) Submission. […] (b) Contents […]