• Article Index

• Knowledgebase Index

• Interpret FDA's QSR

• Find Regulatory Requirements for your country
• GHTF
• Validation Requirements
• Medical Device Software
• Sterilization

• FDA Requirements
• European Union Requirements
• Canadian Requirements

What is an Investigational device exemptions (IDE)?

An approved IDE means that the IRB (and FDA for significant risk devices) has approved the sponsor’s study application and all the requirements under 21 CFR 812 are met.