FDA Submissions – Devices (IDE)
Spectrum Operations, Training and Compliance (OTC) serves faculty and clinical research personnel at Stanford School of Medicine, Stanford University Medical Center, Lucile Packard Children's Hospital, and the Veterans Affairs Palo Alto Health Care System.
Services Provided
- Budget & Billing Support
- Regulatory/Compliance Support
- Study Facilitators
- Training & Education
- Point of Contact for questions about clinical research
OnCore for Non-Cancer Studies
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Contact Information
Spectrum
Operations, Training & Compliance
800 Welch Road
MC: 5737
Palo Alto, CA 94304
(650) 498-6498
Fax (650) 723-8552
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