By Kelly A. Briganti, Editorial Director, G2 Intelligence
Starting April 15, the FDA will begin implementing an expedited approval process for devices subject to premarket approval or de novo requests that can satisfy unmet needs for life-threatening or irreversibly debilitating conditions. Participation in this Expedited Access Pathway (EAP) program, is voluntary at the sponsor’s request. Jeffrey Shuren, M.D., J.D., Director of the U.S. Food and Drug Administration’s Center for Devices and Radiological Health, explains the reason behind the EAP in an April FDA Voice blog: “We know that patients with life-threatening or irreversibly debilitating conditions lack treatment and diagnostic options. At the same time, delayed access may mean the difference between life and death, or may result in irreversible disability.”
The FDA’s guidance titled Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions, released April 8, finalizes draft guidance issued last year, defining criteria for eligible devices, benefit-risk determinations, and types of clinical evidence that support applications for approval.
Eligible devices include breakthrough technologies, those that can provide a clinically meaningful benefit over existing technologies, and devices that serve an unmet need for which there are no appropriate existing technologies. The FDA’s guidance cites as examples of diagnostic technologies that could qualify: “an assay based on existing and commonly used technology (e.g., immunohistochemistry) if it provides a clinically meaningful advantage when used with a highly effective therapeutic; and novel IVDs developed using next generation sequencing (NGS) technology.” More specific examples include a “group of molecular tests to identify a large number of potential pathogens including common, rare, and/or emerging pathogens simultaneously” or an “IVD assay that detects a genomic variant for the purposes of identifying patients with certain cancers” who are appropriate candidates for a certain drug treatment.
To help speed access to these devices, the FDA finalized a second guidance, titled Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval, that discusses reliance on more postmarket than premarket data to support premarket approval applications. Factors that will be considered in deciding whether data can be collected postmarket will include the probable public benefit of the device and “extent of postmarket controls.” Shuren also indicated in FDA Voice that post rather than premarket data could be acceptable when the risk of harm is low, postmarket surveillance is capable of quickly identifying serious harm and it’s likely post-market data can be collected in a timely manner.
The FDA anticipates acting on requests for EAP qualification within 30 days of receipt.