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 includes 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 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 and to provide a general explanation of the reasons for those decisions.
In an effort to promote timely initiation of 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 there are outstanding issues 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:
- the investigation may not support a substantial equivalence or de novo classification determination or approval of the device;
- the investigation may not meet a requirement, including a data requirement, relating to the approval or clearance of a device; or
- 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 determine whether the pivotal study design may support a marketing application if it is successfully executed and meets its stated endpoints without raising unforeseen safety concerns. To meet this interest, FDA is proposing a new, voluntary program intended to facilitate the development of trial designs that may support a marketing approval or clearance. The Agency recognizes that this type of voluntary program will not likely be suitable for all IDE sponsors and does not intend that this program become a routine step prior to submission of an IDE, nor is this program intended to replace or be a substitute for the existing Pre-Submission process.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.