By Stewart Eisenhart, Emergo Group
US medical device market regulators are launching a new expedited market access program for select high-risk devices targeting life-threatening diseases or ailments.
First proposed in early 2014, the Expedited Access Pathway (EAP) is open to devices normally subject to Premarket Approval (PMA) or de novo registration but that can benefit patients suffering from otherwise hard-to-treat afflictions; for devices that qualify for EAP, Food and Drug Administration officials work with manufacturers to reduce timeframes and costs associated with market authorization in order to bring these products to market faster in the US.
Qualifying devices go through priority and more interactive FDA review, and are also assigned FDA case managers. How extensive EAP features are for registrants, however, depends on the availability of agency resources – something manufacturers should keep in mind when deciding whether to sign up for EAP review.
How does a device qualify for EAP?
Medical devices that would either require PMA or de novo applications may qualify for EAP participation provided they’re intended to treat or diagnose life-threatening or irreversibly debilitating diseases or conditions. Qualifying devices must also meet one of four additional criteria:
- No alternative treatment or diagnostic tool for the disease exists
- The device uses novel technology that provides greater clinical benefit than currently used technology
- The device itself provides greater clinical benefit than existing alternative means of treatment or diagnosis
- The device’s availability serves patients’ best interest
Finally, EAP applicants must submit draft data development plans deemed acceptable by FDA reviewers.
Ideally, manufacturers interested in EAP should contact the FDA while developing their devices, before requesting Investigational Device Exemption (IDE) pivotal studies. Preparing for EAP applications during product development ensures that data collected in IDE studies can also be used in manufacturers’ market authorization submissions.
What to include in an EAP application
To request participation in EAP, a manufacturer should submit a Pre-Sub requesting EAP designation to the FDA’s Center for Devices and Radiological Health (CDRH) or Center for Biologics Evaluation and Research (CBER).
Pre-Sub requests should include cover letters, device descriptions, proposed intended use and indications for use statements, and draft data development plans that should contain the following components:
- Data collection plan description and summary, including study synopsis and design
- Outline of planned and/or completed clinical and nonclinical testing
- Summaries of completed clinical and/or nonclinical studies
- Proposed pre- and post-market data collection plans
The FDA plans to notify applicants within 30 days whether they qualify for EAP designation, or to request any additional information needed to make a final decision. According to the agency, special attention will be paid to how applicants plan to manage their post-market data collection, which may reduce pre-market data requirements and thus speed up applicants’ market authorization.
The FDA will start accepting applications for EAP participation April 15, 2015. Once the new program gets underway, an actual track record of by how much – or whether – EAP provides speedier US market access than standard PMA or de novo pathways.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.