FDA seeks to encourage medical device research and innovation to address important clinical needs and improve patient care. In many cases, device development and evaluation include clinical investigation. This guidance document has been developed to facilitate the initiation of clinical investigations to evaluate medical devices under FDA’s Investigational Device Exemptions (IDE) regulations, Title 21 Code of Federal Regulations (CFR) Part 812.
FDA approval of an IDE submission allows the initiation of subject enrollment in a clinical investigation of a significant risk device. This guidance is intended to provide clarification regarding the regulatory implications of the decisions that FDA may render based on review of an IDE as well as a general explanation of the reasons for those decisions.
In an effort to promote timely initiation of subject enrollment in clinical investigations in a manner that protects study subjects, FDA has developed methods to allow a clinical investigation of a device to begin under certain circumstances, even when outstanding issues remain regarding the IDE submission. These mechanisms, including Approval with Conditions, Staged Approval, and communication of outstanding issues related to the IDE through Study Design Considerations and Future Considerations, are described in this guidance.
FDA’s decision-making for IDEs was modified with passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. No. 112-144). Section 601 of FDASIA amended Section 520(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to specify certain situations in which FDA cannot disapprove an IDE. Section 520(g)(4)(C) of the FD&C Act states that, consistent with section 520(g)(1), FDA shall not disapprove an IDE because:
- (i) the investigation may not support a substantial equivalence or de novo classification determination or approval of the device;
- (ii) the investigation may not meet a requirement, including a data requirement, relating to the approval or clearance of a device; or
- (iii) an additional or different investigation may be necessary to support clearance or approval of the device.
However, the Agency recognizes that some IDE sponsors may wish to ensure that the pivotal study design may support a marketing application if it is successfully executed, meets its stated endpoints, and does not raise unforeseen safety concerns. Trough mechanisms such as Pre-Submission process, FDA wishes to work interactively with sponsors interested in addressing important limitations with such a study that might impair its ability to support a future marketing application.