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# CDRH’s Pena Leaves FDA to Join Jacobs Institute
- URL: https://www.fdaweb.com/cdrhs-pena-leaves-fda-to-join-jacobs-institute/
- Published: 2021-02-08T12:00:00.000Z
- Updated: 2026-09-14T16:45:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148611

CDRH Office of Neurological and Physical Medicine Devices director **Carlos Pena** has left the agency to develop the newly established Office of Regulatory Services at Jacobs Institute in Buffalo, NY. The institute says its mission is to “accelerate the development of next-generation technologies in vascular medicine through collisions of physicians, engineers, entrepreneurs, and industry.” Pena spent over 20 years in federal government, including a stint at the White House (2012 to 2014) during the Obama administration.  

Pena told the [*Buffalo News*](https://buffalonews.com/news/local/jacobs-institute-hires-ex-fda-official-to-accelerate-innovation/article%5F874cf286-67f4-11eb-ac0d-57b88f34a25e.html?ref=fdaweb.com) that he became familiar with the Jacobs Institute during visits for training programs. “I was surprised and impressed upon the intersection of so many different components of the medical device development pipeline, with University at Buffalo, Kaleida Health, the Gates Vascular Institute, Children's Hospital and Jacobs Institute all coming together,” he said. “It’s really rare to find a single site that has all these components working together.”  

The institute’s CEO, **William Maggio,** said it was time to establish an Office of Regulatory Services to provide “materially substantive support to the medical device industry, whether that was the biggest companies in the world or the most interesting startups through our Idea to Reality Center.” Pena said he has three goals for the new office: providing consulting services on the right regulatory path to follow; “de-risking” device technologies they are developing, and engaging with FDA.