Investigational Device Exemption
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval * (PMA) application or a Premarket Notification 510(k) submission to FDA. The 510(k) demonstrates that the device to be marketed is at least as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to PMA requirements.
The submitter must receive an order from the FDA (usually within 90 days) which finds the device to be SE and states that the device can marketed in the U.S. This order "clears" the device for commercial distribution. Clinical studies with devices of significant risk must be approved by FDA and by an Institutional Review Board (IRB) before the study can begin. Studies with devices of nonsignificant risk only require IRB approval prior to initiation.
The FDA assigns a specific identifier number that corresponds to each device granted an IDE. The FDA also assigns all approved IDEs to one of two categories to assist the Medicare program in determining coverage for such devices. The two categories are listed below:
Category A: Experimental Investigational
Innovative devices for which absolute risk of the device type has not been established. The Centers for Medicare & Medicaid Services (CMS) do not cover Category A devices under Medicare.
Section 731(b) of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 authorizes Medicare to cover the routine costs of clinical trials involving IDE Category A devices when the device is intended for use in the diagnosis, monitoring, or treatment of an immediately life-threatening disease or condition. The Category A device itself remains non-covered.
Category B: Non-experimental InvestigationalCMS may cover Category B devices if they are considered reasonable and necessary and if all other applicable Medicare coverage requirements are met. Payment for a Category B IDE device may not exceed the amount that would have been paid for a comparable approved device.
Coverage of Category B IDE devices is predicated, in part, upon their status with the FDA. In the event a sponsor (e.g., manufacturer) loses its Category B status or violates relevant IDE requirements necessitating FDA's withdrawal of the IDE approval, all payment for the device should cease. Billing for an IDE means that the provider attests that the study was approved at the time the service was rendered.
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