Guidance in assessing if you need an investigational new drug (IND) or investigational device exemption (IDE) for your study
Keyword: Investigational Device Exemption
Support and expertise to prepare and submit investigational new drug (IND) and investigational device exemption (IDE) pre-submission meeting requests to the FDA
Support and expertise to prepare and submit investigational new drug (IND) and investigational device exemption (IDE) applications to the FDA
FDA regulations for conducting clinical trials involving non-significant risk devices