FDA Submissions – Devices (IDE)
The STUDY SET-UP stage includes activities that occur after the study has been designed and developed, and before you begin to enroll patients.
This stage includes activities in areas such as:
- contracts & grant proposals
- IRB approval
- research management compliance
- study budgeting & billing
- required registration of trial
The U.S. Food and Drug Administration website provides information for regulated industry on determining how to comply with the federal laws and regulations governing medical devices. See their Device Advice: Device Regulation and Guidance page for the following information and more:
- Overview of Medical Device Regulation
- Compliance Activities (Medical Devices)
- Postmarket Requirements
- Standards
Training
Spectrum works in collaboration with the IRB and the Cancer Clinical Trials Office to provide education and training for investigators and research teams conducting research with INDs and IDEs held by a Stanford investigator.
Next Steps
- More Information
FDA Device Advice website - FDA Investigational Device Exemption website
- Stanford BioDesign videos
-Regulatory Basics (4.2)
-Regulatory Strategy (5.4) - Tutorial – FDA Approval
Online tutorial from Stanford Biodesign - Download Sample
Sample Regulatory Binder Table of Contents for IDE Studies (pdf, rv 07/22/10) - Spectrum Training
Email a Spectrum Study Facilitator