Regulatory pathway · all topics

Investigational Device Exemption (IDE)

An IDE under 21 CFR Part 812 allows an unapproved device to be used in a clinical study to gather safety and effectiveness data. Required when device poses significant risk. Sponsor must obtain IRB approval, informed consent, monitor adverse events, and report under 21 CFR 812.150. Abbreviated IDE (812.2(b)) applies to non-significant-risk studies and only requires IRB approval, not FDA. Early Feasibility Study IDE allows first-in-human under more flexible evidence standards.

Source

FDA, 'Investigational Device Exemption (IDE)' (21 CFR Part 812)

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide

How MedTek OS handles this

Compass drafts the investigational device exemption (ide) workflow with confidence-gated content.

The platform refuses to generate content below the threshold for this artifact class. Every claim carries a citation chain back to RIG, audit-logged with HMAC integrity.

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