Practical Advice for Medical Devices Firms

www.clinipace.com Investigational device exemption If an investigational device study presents a significant risk to subjects, a sponsor must obtain FDA approval of an investigational device exemption (IDE) from the Office of Device Evaluation (ODE). An IDE allows the investigational device to be used in a clinical study of safety and effectiveness required to support a Premarket Approval application or a Premarket Notification 510(k) submission to FDA. The IDE must contain information concerning the study’s investigational plan, report of prior investigations, device manufacture, Institutional Review Board actions, investigator agreements, subject informed consent form, device labeling, cost of the device, and other matters related to the study. The FDA has 30 calendar days after receiving the application to approve or disapprove an IDE submission. The FDA encourages sponsors to meet with the ODE reviewing division before the IDE application is submitted for review (FDA, IDE Approval Process). The reviewing division provides advice for developing supporting pre-clinical data or the investigational plan. These meetings may take the form of telephone conference calls, video conferences, or face-to-face discussions. Formal guidance meetings, such as a determination meeting or an agreement meeting, may be arranged to review scientific evidence needed to demonstrate efficacy and investigational plans such as clinical protocols. If an agreement is reached between FDA and the sponsor or applicant regarding the parameters of an investigational plan (including a clinical protocol), the terms of the agreement are put in writing and made part of the administrative record by the FDA. Importance of seeking feedback Working with the FDA early in the process of developing a medical device can save time, money, and frustration. Getting to know the individual review division and working with them to determine efficacy and safety criteria can prevent your study from having “red flags” down the road. The FDA looks favorably on carefully designed studies that include accurate observations made by competent personnel. Studies with unclear objectives, poorly defined or analyzed outcomes, improperly documented sample size, unexplained missing patients, unexplained unblinded analytic changes, or serious adverse events that are dismissed Page | 3 ©2012 Clinipace Worldwide, Inc. All rights reserved.

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