Reference cardRegulations and guidance
I am moving from drug to device trials. Where are the IDE rules?
The regulations for Investigational Device Exemptions (IDE) are in 21 CFR Part 812. The eCFR provides the current text.
Next steps
- Read 21 CFR Part 812 in the eCFR.
From the question: I am moving from drug to device trials. Where are the IDE rules?