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# FDA Pushing Early Device Feasibility Studies
- URL: https://www.fdaweb.com/fda-pushing-early-device-feasibility-studies/
- Published: 2017-06-14T12:00:00.000Z
- Updated: 2026-09-14T22:29:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138931

CDRH director **Jeffrey Shuren** and Division of Cardiovascular Devices director **Bram Zuckerman** say the agency has a new program to encourage early feasibility studies for new medical devices in the U.S. Writing in an *FDA Voice* blog [post](https://blogs.fda.gov/fdavoice/index.php/2017/06/how-creative-fda-regulation-led-to-first-in-the-world-approval-of-a-cutting-edge-heart-valve/?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery), the two say the studies “allow for early clinical evaluation of devices to provide proof of principle and initial clinical safety data, and may be appropriate early in device development when clinical experience is necessary because nonclinical testing methods are not available or adequate to provide the information needed to advance the developmental process.”

Although many U.S. medical device companies have become accustomed to going overseas to conduct early feasibility studies for new heart valve devices, securing marketing authorization in other countries first and then returning to the U.S. for pivotal clinical trials before FDA approval, Shuren and Zuckerman write, many are now staying in the U.S., saving on travel costs, enjoying more convenient communication with investigators, and benefiting from early interactions with FDA.

Their comments are part of a blog post describing how creative FDA regulation led to first-in-the-world 6/5 approval of the Sapien 3, a cutting edge heart valve. When the original Sapien transcatheter heart valve was approved by FDA nearly six years, the U.S. was the 42nd country to approve the device. The authors say that in the intervening time, the FDA Heart Valve Review Team took steps to enable the U.S. to be the first country to approve the Sapien 3.

“We became more consistent, predictable, and transparent about our expectations,” they say, “which helped significantly reduce the total time to initiating clinical studies. And we worked closely with the industry on creative clinical trial design and the use of other sources of clinical evidence that could demonstrate that the device is safe and effective when used in the intended patient population.”