FDA Update on EAP Program: 29 Decisions in First Year

A year into FDA’s Expedited Access Pathway program, the agency has made 29 decisions on requests — accepting 17 and denying 12 — with review decisions usually made in 30 days.

Requests have included heart, brain and kidney devices from both startups and major corporations.

Launched by the FDA in April 2015, the program facilitates access to breakthrough medical device technologies for life-threatening conditions (IDDM, April 10). The FDA works with device sponsors throughout the process, beginning with development.

“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 agency says.

“For these companies, discussing their Data Development Plan with the FDA and agreeing on a roadmap to their marketing application and beyond is an important part of a successful review.”

For devicemakers interested in the EAP program, the FDA recommends being prepared with a thorough Data Development Plan for future submissions.

The Data Development Plan should include three sections:

• An explanation and justification for the proposed balance of premarket and postmarket data collection, if a premarket-postmarket data shift is proposed and applicable;
• A description and summary of the data collection plan, including study synopses and study design; and
• A timeline for the development and marketing of the device, as well as for the postmarket data collection.

Meanwhile, lawmakers are also working to improve access to breakthrough technologies. The Senate HELP Committee advanced a bill in March to expand the expedited review of breakthrough medical devices by including all classes of devices, rather than only Class III.

Reduced Compliance Timeframes

The bill would also reduce compliance time frames and allow shorter and smaller clinical trials (IDDM, March 28).

In April, Senators introduced the Ensuring Patient Access to Critical Breakthrough Products Act to expedite CMS decisionmaking for innovative medical technologies for Medicare recipients with life-threatening illnesses.

Read the FDA’s update on the EAP here: www.fdanews.com/06-02-16-EAPUpdateFDABlog.pdf. The Ensuring Patient Access to Critical Break through Products Act can be found here: www.fdanews.com/06-02-16-HR5009.pdf. — Joya Patel