On August 18, 2014, the U.S. Food and Drug Administration (FDA) published “FDA Decisions for Investigational Device Exemption Clinical Investigations”, a draft guidance that details FDA decision making when it comes to approving or disapproving investigational device exemption (IDE) applications and provides information about steps sponsors may take after FDA makes a certain decision.
In most cases, a medical device must comply with certain requirements, such as performance standards and premarket approval, before FDA will allow the device to enter and/or be distributed in the United States. With IDE approval, a device may bypass some of the regulatory requirements for medical devices and still be legally shipped into the U.S. for the purpose of conducting investigations on the device. All clinical studies of investigational devices require IDE approval by an institutional review board (IRB), but high risk devices also require FDA approval.
FDA can approve, approve with conditions, or disapprove an IDE application. Once FDA receives an application, the agency has 30 days to inform the sponsor its decision. If FDA fails to do so, the IDE application is automatically approved. FDA looks at IDE applications to determine whether there are sufficient data to support the initiation of human clinical studies and to ensure the safety of study participants and address any other concerns. If approved (with or without conditions), FDA will specify a maximum number of U.S. subjects and investigational sites in its decision letter. Studies must be conducted in accordance with these limits. FDA may also suggest modifications to the study design, but sponsors are not required to implement them.
FDA will approve an IDE application if the sponsor has provided sufficient data and the agency has no outstanding issues that need to be addressed to support the proposed investigational plan. The sponsor may begin subject enrollment immediately upon receiving IRB approval.
FDA Approval with Conditions
If FDA determines there are issues that need to be addressed in a timely manner, but there are no subject safety concerns, the IDE will be approved with conditions. Just like FDA approval without conditions, the sponsor may immediately begin enrollment once the sponsor receives IRB approval. The difference is that the sponsor will have 45 days from the date of the FDA’s decision letter to submit information addressing the issues identified in the letter. Sponsors can request an extension to respond to FDA, but if the sponsor does not respond in the given amount of days, FDA may place a hold on the study or take other regulatory action.
If FDA identifies outstanding issues that need to be resolved before subject enrollment begins, the IDE will be disapproved. The sponsor will be unable to initiate enrollment, but will be able to amend the application and respond to the issues identified in FDA’s decision letter. If the outstanding issues are resolved, FDA may grant an approval or approval with conditions.
As an alternative to disapproving an IDE application, FDA may decide to grant “staged approval” or “staged approval with conditions.” This means that FDA grants approval for only a portion of the intended study while certain questions and issues are resolved, after which the study may gain approval or approval with conditions. This occurs if FDA finds that beginning a portion of the study would be significantly beneficial compared to the risks.
IDE applications must include the informed consent document that is intended to be given to potential study participants. Informed consent documents inform potential subjects of important information about the study, including the risks and benefits of participation. 21 CFR Part 50 lists specific requirements for the format of informed consent documents. Failing to comply with the format requirements can be cause for approval with conditions or even disapproval.
Registrar Corp is an FDA consulting firm that helps medical device establishments comply with FDA regulations. We can properly register an establishment with FDA, review device labeling for FDA compliance, and properly format a 510(k). For questions about IDE applications or other FDA medical device regulations, contact Registrar Corp at 1-757-224-0177 or tweet us @RegistrarCorp. We are also available 24/7 through our Live Help chat service.