Important: Clinical study of a new indication or new patient population for an already marketed device falls under the IDE regulations. Per Penn State University Policy RP05, “Research Quality in Human Participant Research,” it is required that the Office for Research Protections Quality Management Program be contacted to provide support for the submission process for IDEs or Study Risk Determinations, and to perform an administrative review of the submission prior to being sent to the FDA. An investigational device exemption (IDE) is a regulatory submission to the Center for Devices and Radiological Health (CDRH). If approved, it allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. IDE requirements:
- Study approved by an institutional review board (IRB). If the study involves a significant risk device, the IDE must also be approved by FDA; Informed consent from all patients obtained and documented;
- The device is labeled “CAUTION- Investigational Device. Limited to investigational use only;” Sponsor-investigator complies with monitoring requirements;
- Records and reports are maintained;
- Investigator cannot promote or commercialize (charge for) the device.
FDA Guidance: Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies Two important elements of the guidance are:
- FDA approval of an IDE application for an early feasibility study, including some first-in-human studies, may be based on less nonclinical data than would be expected for other types of studies (e.g., traditional feasibility or pivotal).
- The introduction of new approaches to facilitate timely device and clinical protocol modifications during an early feasibility study, while still maintaining compliance with the IDE regulations in 21 CFR 812: more types of modifications that can be made under a 5-day notification without prior FDA approval, as compared with other types of studies; a contingent approval process that permits changes contingent upon acceptable; nonclinical test results without requiring additional FDA action; and interactive review of IDE supplements and amendments.