Final Guidance on Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions.

This guidance document explains the principal factors that FDA considers when assessing benefits and risks of original IDE applications, IDE amendments and IDE supplements for human clinical investigations of certain medical devices to determine safety and effectiveness. The approach discussed in this guidance is applicable to studies subject to the IDE requirements in 21 CFR part 812, including postmarket studies. This guidance applies to both diagnostic and therapeutic devices

The purpose of the IDE process is “to encourage, to the extent consistent with the protection of the public health and safety and with ethical standards, the discovery and development of useful devices intended for human use and to that end to maintain optimum freedom for scientific investigators in their pursuit of that purpose. FDA approval of an IDE application prior to study initiation is typically required for a clinical investigation conducted in the U.S. of a significant risk device that is not approved or cleared for the indication being studied. FDA will generally disapprove an IDE application if potential risks of the proposed study are not justified, or if data provided are insufficient to adequately characterize the safety profile of the device such that, based on the data contained in the IDE application, human clinical investigation is not considered reasonable.

FDA believes that the use of a common framework and structured approach to assessing IDE benefits and risks will facilitate not only the submission of relevant evidence and knowledge but also a clear rationale for why the submitted information is sufficient to justify the initiation of the proposed study. FDA recommends IDE sponsors provide as part of the IDE application a section that summarizes the key considerations in the IDE benefit-risk assessment. The benefit-risk summary should provide a concise synopsis and may reference relevant sections in the IDE application where supporting information and evidence can be found. The intent of this summary is not to provide an all-encompassing summary of the benefit-risk assessment, but rather to focus on those items which are likely to significantly affect FDA’s decision or recommendation.

This guidance document was issued on January 13, 2017 and has a 60 day implementation period. FDA will host a webinar on Thursday, February 23, 2017 to help manufacturers and other interested
stakeholders understand the information provided in this final guidance document.  

Following a brief presentation, the FDA will respond to questions.

Webinar details:

Registration is not necessary.

• Date: Thursday, February 23, 2017  
• Time: 12:30 p.m. – 2 p.m. Eastern Time (please connect by 12:15 p.m.)

To hear the presentation and ask questions:

Dial: 800-475- 0553; passcode: 1759468 | International: 1-415- 228-5009; passcode: 1759468

Conference number: PW2531042

To view the slide presentation during the webinar: Join the event

Due to expected high participation of this webinar, please use the following link to access the live presentation if the previous link returns an error message upon logging in: Live Meeting

Following the webinar, a transcript, recording and slides will be available at Medical Device Webinars and Stakeholder Calls.
The slide presentation will be available at this site on the morning of the webinar.

If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at [email protected], or by phone 1-800- 638-2041, or 301-796- 7100.

For more information about the guidance please visit Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions

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