CONDUCTING A PHYSICIAN-SPONSORED INVESTIGATIONAL DEVICE EXEMPTION

According to 21 CFR 812, a Sponsor-Investigator is “an individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is administered, dispensed, or used”.  When a Sponsor-Investigator conducts a device study it may be referred to as a Physician-Sponsored IDE (PS-IDE). However the PS-IDE is organized, the overlying principle is that the individual conducting the study must conduct and oversee the study according to the Food and Drug Administration (FDA) regulations governing both investigators and sponsors.

Chaos can sometimes ensue when one begins down the path of a PS-IDE. This white paper will make sense of that chaos by providing: a brief overview of:

• A brief overview of initiating a PS-IDE
• A breakdown of the responsibilities of the investigator
• The additional sponsor responsibilities assumed by the Sponsor-Investigator
• A thoughtful discussion on the records and reports of the Sponsor-Investigator