Devices

Expedited Access Program Speeds New Devices: CDRH

David McFarland

— 2 min read
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Three CDRH officials say the Expedited Access Program (EAP), which is completing its first year, allows FDA and medical device sponsors to focus on the early stages of product development, which can be helpful for new products that address unmet and critical life-threatening patient needs. “In fact,” they write in an FDA Voice blog post, “we think the EAP program will have the most impact when sponsors request EAP designation prior to beginning an IDE pivotal study. That way we can work with the sponsor to make sure the data being collected in the pivotal study are appropriate to include in the device’s manufacturing submission.”

Listed as authors of the post are Office of Device Evaluation acting Q-submission program policy lead Erin Cutts, Office of Device Evaluation clinical trials director Owen Faris, and CDRH director Jeffrey Shuren.

They say that in its first year, FDA has made 29 decisions on requests for EAP designations, with 17 accepted into the program and 12 denied. Decisions were typically made within 30 days, they say. EAP designation requests have included devices for the heart, brain, and kidneys that are manufactured by small start-up companies and large corporations. “We expect that our resources and focus on these promising technologies under the EAP program will allow them to be evaluated and enter the market more quickly,” the post says, “therefore providing options to the patients who need them most.” All EAP products ultimately undergo either PMA or de novo review.

The three say that projects should meet these criteria for EAP designation: 

  •          the device should treat or diagnose a life-threatening or irreversibly debilitating disease;
  •          the device should address an unmet need, which is usually shown by comparing it to other available options; and
  •         the company should have a data development plan outlining what will be included in future submissions to FDA so that it and the agency can agree on the high-level items up front to prevent confusion and delays later in the review process.

“As the program has grown in the past year, we’ve learned that companies who benefit most from this program are those that have a preliminary proof of principle for how their device works, but haven’t undertaken formal studies to support future submissions to FDA,” the post concludes. “For these companies, discussing their data development plan with FDA and agreeing on a roadmap to their marketing application and beyond is an important part of a successful review.”

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