FDA Submissions – Devices (IDE)
Spectrum 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.
- Budget & Billing Support
- Regulatory/Compliance Support
- Training & Education
- Point of Contact for questions about clinical research
OnCore CTMS for
Operations, Training & Compliance
800 Welch Road
Palo Alto, CA 94304
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
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.