How One Doctor Is Shaping Regulatory Approaches For Medical Products

Dr. Michelle Tarver’s leadership at the FDA’s Center for Devices and Radiological Health (CDRH) marks a shift towards prioritizing patient safety in medical product approvals.

At a Glance

Dr. Michelle Tarver became acting director of CDRH on July 28
CDRH aims to incorporate patient perspectives into medical device evaluation
Patient-reported outcomes and preferences are being integrated into regulatory decisions
The FDA has increased annual medical device authorizations five-fold since 2009

New Leadership at CDRH: A Focus on Patient Safety

The Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has settled in for significant leadership change. Dr. Michelle Tarver took over the post as acting director on July 28, following the retirement of long-serving director Jeff Shuren. Just this week, Dr. Tarver was named as the permanent replacement for Shuren. This transition came at a crucial time for the regulatory body, which has seen a substantial increase in medical device authorizations over the past decade.

Under Shuren’s leadership, the CDRH developed new programs, including the breakthrough devices program and revamped clinical trials. The center also played a critical role during the COVID-19 pandemic, issuing over 225 emergency use authorizations. However, with Dr. Tarver at the helm, the focus is expected to shift towards a more patient-centric approach in regulatory practices.

A standing ovation for Michelle Tarver, MD, PhD, Deputy Director for Transformation and Acting Director, @US_FDA CDRH, winner of the Health IT Health Equity Advocate Flywheel Award! 🌟

Pictured accepting on her behalf: Dr. Matthew Diamond, Chief Medical Officer for Digital… pic.twitter.com/kePvsKTzin

— GovCIO Media & Research (@GovCIOMedia) September 20, 2024

Integrating Patient Perspectives into Medical Device Evaluation

Dr. Tarver’s leadership is anticipated to build upon CDRH’s existing efforts to incorporate patient input into the medical device evaluation process. This approach aligns with the center’s vision statement, which emphasizes providing patients with access to high-quality, safe, and effective medical devices.

According to the CDRH’s vision statement, “Patients in the United States have access to high-quality, safe, and effective medical devices of public health importance first in the world.”

The CDRH has been actively encouraging the medical device industry to engage with patients and collect patient-focused outcomes. This initiative began a decade ago, with the center emphasizing patient centrism in its regulatory approach. In 2016-2017, the “Partnering with Patients” strategic priority involved over 90% of CDRH staff engaging directly with patients to better understand their perspectives.

Patient-Reported Outcomes and Preferences in Regulatory Decisions

Under Dr. Tarver’s leadership, the integration of patient-reported outcomes (PROs) and patient preferences into scientific evidence for regulatory decisions is expected to continue and potentially expand. PROs measure patient feelings, functions, and survival, which are particularly important in clinical trials for conditions like kidney disease.

The FDA has already issued guidance on submitting patient-preference information and its inclusion in decision summaries and labeling. This approach has led to expanded labeled indications for medical devices based on patient-preference studies. As Dr. Tarver takes the reins, there is an expectation that these efforts will be further emphasized and refined.

Balancing Innovation and Safety

While the CDRH under Jeff Shuren’s leadership saw a significant increase in medical device authorizations, Dr. Tarver’s approach is expected to place a stronger emphasis on long-term safety. This shift aims to restore trust in the regulatory agency while still allowing for innovation in the medical device industry.

“We made significant changes to existing programs and innovated. We created new programs, policies, practices, and processes,” said Shuren.

The challenge for Dr. Tarver will be to maintain the pace of innovation while ensuring that all medical products released to the market are not only effective but also safe for long-term use. This approach seeks to align regulatory procedures with the best interests of patients, ultimately promoting their health and well-being above the speed of product availability.

CDRH's Dr. Michelle Tarver, Jodi Duckhorn, and Alicia Witters join MDIC's Patient Engagement Forum to share key areas of opportunity to improve patient communication. Register today: https://t.co/dSNGnYxcOs @FDADeviceInfo pic.twitter.com/SUfFNY7Q9w

— MDIC (@MDIConline) November 10, 2020

Looking Ahead: A Patient-Centered Future for Medical Device Regulation

As Dr. Michelle Tarver settles into her role as permanent director of the CDRH, the medical device industry and patients alike will be watching closely. Her expertise in patient-centered care is expected to lead to more comprehensive evaluations of medical devices, potentially setting a new standard for regulatory practices in the field.

As the center continues to evolve its approach to incorporate patient perspectives, the hope is that this will lead to better outcomes for patients and a more robust, trustworthy regulatory process for the medical device industry.