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 FDA’s 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.

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