FDA Submissions – Devices (IDE)
Spectrum support for Clinical Research is divided into four stages, the first of which is DESIGNING YOUR STUDY.
This stage includes tasks and activities that occur early in the design & development of a study, such as:
- biostatistics consultations
- informatics consultations
- bioethics consultations
- identifying co-investigators and collaborators
- exploring funding opportunities
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.