The Food and Drug Administration is fast-tracking qualifying medical devices to patients with life-threatening or irreversibly debilitating conditions that lack treatment and diagnostic options.
The FDAs new Expedited Access Pathway (EAP) program covers certain medical devices that demonstrate potential to address unmet medical needs that are subject to pre-market approval applications (PMA) or are eligible for de novo requests. FDA works with device sponsors to try to reduce the time and cost from development to marketing decision without changing the PMA approval standard of reasonable assurance of safety and effectiveness, the standards for granting de novo requests, or for the FDA standard of valid scientific evidence.
According to Jeffrey Shuren, M.D., director of FDAs Center for Devices and Radiological Health, the program will launch on April 15 when the agency will begin to accept requests for EAP designation. Shuren said his staff will work collaboratively with developers of such devices earlier and more often including the creation of a Data Development Plan that provides predictability and leverages post-market data collection.
The Data Development Plan will shift premarket data collection to the post-market setting, to the extent appropriate, taking into account the public health benefit of these devices, while still meeting the U.S. approval standard of reasonable assurance of safety and effectiveness, writes Shuren in a blog. The premarket data must be adequate to support FDAs high standard for premarket review but can include data based on an intermediate endpoint or a surrogate endpoint reasonably likely to predict clinical benefit.
To qualify for the program, a device must meet at least one of the following criteria:
*No appropriate alternative treatment or means of diagnosis exists.
*Represents a breakthrough technology that provides a clinically meaningful advantage over existing legally marketed technology.
*Offers significant, clinically meaningful advantages over existing legally marketed alternatives.
*The availability of the device is in the best interest of patients.
FDA has released guidance on balancing pre-market and post-market data collection that describes the circumstances under which post-market data collection is appropriate for PMAs and whether or not they meet the criteria for the EAP.
If, after careful analysis, FDA determines that some data can be collected after the device is on the market, then patients in need will benefit sooner, according to Shuren. A few of the factors that can enter into this analysis include a low probability of serious harm, a high likelihood that post-market surveillance can quickly identify instances of serious patient harm and a high likelihood that post-market data collection will be completed in a timely manner.
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