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Understanding Food and Drug Administration Regulatory Requirements for an Investigational Device Exemption for Sponsor-Investigators
  1. M. E. Blair Holbein, PhD, BCAP*,
  2. Jelena Petrovic Berglund, PhD, RAC
  1. From the *Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX, and †Duke University School of Medicine, Duke Translational Medicine Institute, Durham, NC.
  1. Received February 27, 2012, and in revised form May 30, 2012.
  2. Accepted for publication May 30, 2012.
  3. Reprints: M. E. Blair Holbein, PhD, BCAP, University of Texas Southwestern Medical Center, Department of Clinical Sciences, 5323 Harry Hines Blvd., Dallas, TX 75390-9066. E-mail: Blair.Holbein{at}
  4. This work was conducted with support from UT-STAR, NIH/NCRR Grant Number UL1RR024982 and NIH/NCRR Grant Number UL1RR024128. The content is solely the responsibility of the authors and does not necessarily represent the official views of UT-STAR, The University of Texas Southwestern Medical Center at Dallas and its affiliated academic and health care centers, the National Center for Research Resources, or the National Institutes of Health.


Clinical investigators in academic medical centers often perceive federal regulations as a significant obstacle to conducting clinical research. The regulatory authority of the Food and Drug Administration (FDA) extends to clinical studies of medical devices. Consequently, researchers wishing to conduct device research using FDA-approved as well as nonapproved devices must comply with federal regulations for investigational device exemptions (IDE) as described in Title 21 of the Code of Federal Regulations Part 812. FDA regulatory oversight is structured to match the risk to the subject to the risk of the device. Medical device studies can be categorized as follows: meeting exemption criteria, being a nonsignificant risk device, or being a significant risk device. All IDE studies must meet regulations for the protection of human subjects, but no additional federal filing on the part of the investigator is necessary for those that meet exempt criteria. Nonsignificant risk device studies require meeting abbreviated IDE regulatory requirements for the conduct of the study, but no previous FDA approval is required. Significant risk device studies require that the investigator also function as a sponsor and to file an IDE with the FDA for approval before starting. A sponsor-investigator filing an IDE follows the format and content described in 21 CFR 812.20. The study may begin 30 days after the date of submission receipt unless the FDA notifies the sponsor otherwise. While the IDE is active, the sponsor-investigator must meet the requirements for the conduct of the study and the required monitoring and reporting to the FDA.

Key Words
  • Food and Drug Administration
  • investigational device exemption
  • federal regulations
  • significant risk device

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