FDA Issues Two Draft Guidances Regarding Investigational Device Exemptions
On November 10, 2011, the U.S. Food and Drug Administration (FDA) issued two new draft guidance documents regarding Investigational Device Exemptions (IDE) applications for early feasibility studies and clinical investigations. The Agency seeks to foster early-stage development of medical devices in the United States, contribute to medical research, and address important clinical needs to improve patient care.
An IDE allows investigational devices to be used in feasibility or clinical studies in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to the FDA. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE
before the study is initiated. 21 CFR 812. Please see our previous report for more information concerning PMA and 510(k) submissions for medical devices.
Draft Guidance for Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies
The draft guidance regarding IDE applications for early feasibility studies applies to medical devices of significant risk in the early stages of development. Early feasibility studies allow for early clinical evaluation of devices to provide proof of principle and initial clinical safety data to better inform the final design of the device. The guidance permits studies to start earlier in the device development process than previously allowed. However, initiation of early feasibility studies must be justified by a risk-benefit analysis and adequate human subject protection measures. The new draft guidance also permits select device modifications to be made without FDA approval.
FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations
The draft guidance regarding IDE applications for clinical investigations clarifies the FDA’s process for approving clinical trials of medical devices. The draft guidance describes the Agencys methods which allow clinical investigations of devices to begin under certain circumstances even when there are outstanding issues regarding the IDE application. Those methods include: approval with conditions, staged approval, and communication of outstanding issues related to the IDE through future considerations.
The FDA permits an IDE application that receives an approval with conditions to enroll patients in studies while certain issues are being resolved. Those issues may include: data analysis methods that can be resolved prior to gathering the data, minor divergences from study endpoints, or study design assumptions. A staged approval allows studies to begin with a smaller group of subjects while applicants gather additional data, prior to beginning larger general enrollment.
Fuerst Ittleman is well-equipped to assist members of FDA-regulated industry navigate the laws and regulations applicable to medical devices. For more information about the current regulatory framework surrounding medical devices, please contact us at firstname.lastname@example.org.