Abbreviated IDE Requirements
This document describes the FDA regulations specific for conducting a clinical trial with a non-significant risk (NSR) device.
This document describes the FDA regulations specific for conducting a clinical trial with a non-significant risk (NSR) device.
This is a protocol template for investigator-initiated clinical drug trials. It is not intended for use with medical device trials or hematology-oncology trials.
This page includes decision worksheets for investigators who may need to submit an Investigational New Drug or Investigational Device Exemption Application.
This pages includes decision worksheets and FDA guidance documents for investigators who may need to submit an Investigational New Drug or Investigational Device Exemption Application.
This self-guided course is designed to introduce you to regulatory responsibilities of sponsors and investigators of drug and device studies.