FDA Year in Review

“FDA Town Hall Meeting” is a multi-part session held yearly at the Transcatheter Cardiovascular Therapeutics (TCT) conference. At this year’s conference, the first portion, titled “The Year in Review: A Year in Transition,” was introduced by Martin B. Leon, MD, and Bram D. Zuckerman, MD. The Town Hall Meeting is meant to be dynamic and inclusive of key forces from the regulatory environment, clinical scientists, and representatives from industry.

The first portion, titled “FDA-CDRH Perspectives,” was delivered by Matthew G. Hillebrenner, MSE, deputy director of the Division of Cardiovascular Devices at the US Food and Drug Administration. This talk began with a review of reorganization that has occurred in the last year. According to Mr Hillebrenner, his office also took on review of post market manufacturing changes for cardiovascular devices, resulting in an increase in the workload of the division. He also summarized policy changes and major changes in the Medical Device User Fee Act (MDUFA 3) program, including new milestones for communication and a structured pre-submission program. Mr Hillebrenner also briefly described multiple guidance documents of interest, panel meetings on devices, and recent approvals of interest. Lastly, he highlighted a recent decrease in Time to Decision.

Martin B. Leon, MD, founder and chairman emeritus, and director of the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center, delivered the next portion of the session, titled “Interventional Cardiovascular Medicine Perspectives.” He began by describing the heritage of interventional cardiologists and then said that the landscape of interventional cardiology is in a “state of rapid change.” Many obstacles currently exist, such as appropriate use criteria, media scrutiny, and a decrease in PCI volume, and according to Dr Leon, the interventional cardiologist should expect growth in procedures such as TAVR, LAA closure, and peripheral vascular procedures. They should also expect major expenditures of resources to facilitate this growth. The modern era, he says, requires thinking about being clinicians and therapists rather than proceduralists.

Next, Michael A. Mussallem, chairman and chief executive officer at Edwards Lifesciences in Irvine, CA, presented “Medical Device Industry Perspectives.” He briefly discussed MDUFA 3 and its impact on industry. He also highlighted the increase in efficiency of regulatory processes and discussed the total review time from first submission to final FDA decision. Mr. Mussallem pointed out that there is still more work to do on both sides and that med tech adverse events and recalls are on the rise. Lastly, he encouraged optimism based on the positive tone from the FDA.

Lastly, the keynote address, “FDA-CDRH in the Next Decade—A Vision for Change,” was presented by Christy Foreman, director of the Office of Device Evaluation at the FDA. She began with the mission of the CDRH (promotion and protection of public health) and the vision (for patients in the United States to have access to high-quality, safe, and effective medical devices first in the world). According to Ms Foreman, the department has adopted certain priorities to align with the mission and vision, including streamlining clinical trials, balancing pre and post market data, utilizing post approval studies and unique device identifiers, and developing leapfrog guidances. In summary, the FDA is changing to accept new challenges, and regulatory barriers should be removed so the system can foster innovation.