FDA Announces New Director of the Center for Devices and Radiological Health

October 23, 2024

Reading Time : 1 min

Dr. Michelle Tarver is a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology, who serves as the Director of the Center for Devices and Radiological Health (CDRH). She has spent more than 15 years as a medical device regulator, driving strategic initiatives, conducting clinical research and changing organizational culture. Dr. Tarver has held various leadership positions while at the FDA, including the Deputy Director of the Office of Strategic Partnerships and Technology Innovation, and the Program Director of Patient Science and Engagement. Over the course of her career, she has conducted laboratory-based and epidemiological studies, clinical trials and surveys to capture patient preferences, as well as developed registries and patient-reported outcome measures. Dr. Tarver has extensive policy experience in crafting regulations, guidances and conducting premarket and postmarket reviews. She most recently served as the Deputy Center Director for Transformation, steering the development, implementation and direction of CDRH’s transformative projects and strategic initiatives. Under her leadership, CDRH has launched efforts to amplify the perspectives of people living with medical conditions, foster collaboration across the health care ecosystem and stimulate creative evidence generation pathways.

Dr. Tarver received a B.S. in Biochemistry from Spelman College in Atlanta and completed the M.D./Ph.D. program at the Johns Hopkins University School of Medicine and Bloomberg School of Public Health.

Share This Insight

Previous Entries

Eye on FDA

June 2, 2025

On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026
budget request. The release of these FY26 budget materials is timely as Secretary Kennedy and the Food and Drug Commissioner Dr. Makary have started to
testify before Congress on the FY26 budget and the House and Senate Appropriations Committees are moving forward with their annual appropriations work.
Further still, the House Appropriations Committee’s Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies is
scheduled to markup their FY26 Ag-FDA Approps bill later this week.
...

Read More

Eye on FDA

May 23, 2025

Yesterday, the White House’s Make America Healthy Again (MAHA) Commission, led by the Department of Health and Human Services (HHS) Secretary
Robert F. Kennedy Jr. released its inaugural health report titled, Make Our Children Healthy Again, delivering one of the first widely anticipated deliverables
from the MAHA Commission Executive Order issued earlier this year and noted in our prior alert. The 72-page assessment examines the rising rates of
childhood chronic disease in the country—including obesity, heart disease and diabetes—and explores potential contributing factors. Specifically, the report
identifies and focuses on four potential drivers:
...

Read More

Eye on FDA

May 12, 2025

On May 9, 2025, the U.S. Food and Drug Administration (FDA) granted three color additive petitions, approving two new colorings and expanding one existing
approval. These approvals come after the agency’s announcement last month to phase out all petroleum-based synthetic dyes in food by the end of 2026
and transition to natural alternatives (see our post here). Under section 721 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), color additives (unless
exempt from batch certification) are subject to FDA approval to determine their safety for use in food. The agency evaluates the safety of color additives
based on multiple factors including projected human dietary exposure to the additive, toxicological data, and other relevant information. Once FDA approves
a color additive petition, any manufacturer can use the additive in foods for the approved intended uses.
...

Read More

Eye on FDA

May 8, 2025

In the last two weeks, the Department of Health and Human Services (HHS) has filled key artificial intelligence (AI) positions at HHS and the U.S. Food and
Drug Administration (FDA). These appointments, as well as recent statements from HHS and FDA leadership, align with the Trump administration’s intention
to use AI to improve regulatory efficiency at HHS and beyond.
...

Read More

Eye on FDA

April 23, 2025

This week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS), announced a series of
new measures to phase out all petroleum-based synthetic dyes in food by the end of 2026. This initiative is part of the broader “Make America Healthy Again”
(MAHA) agenda aimed at bolstering food safety. Citing growing concerns about the potential role of petroleum-based food dyes in childhood diabetes,
obesity, depression and attention-deficit/hyperactivity disorder (ADHD), the agency plans to establish a national standard and timeline for the food industry to
transition to natural alternatives.
...

Read More

Eye on FDA

April 16, 2025

On April 10, 2025, the Food and Drug Administration (FDA) announced its plan to replace animal testing in the development of monoclonal antibody therapies
and other drugs in one of the first announcements by the agency since Commissioner Makary was confirmed to lead it. In its announcement, FDA highlighted
that this more modern approach is designed to improve drug safety and accelerate the evaluation process, while also reducing animal experimentation,
lowering research and development costs, and lowering drug prices.
...

Read More

Eye on FDA

April 2, 2025

On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical
Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets aside the Food & Drug Administration’s (FDA) final rule, Medical Devices; Laboratory
Developed Tests (the LDT Rule).1 The LDT Rule would have required laboratories offering LDTs to meet medical device requirements. The preamble to the
LDT Rule provided a multi-stage phase out of FDA’s enforcement discretion policy, under which the first set of regulatory requirements would have been
actively enforced beginning May 6. While many labs are breathing a sigh of relief after the publication of this order, questions remain as to how the agency
will proceed and the broader implications for regulation of lab tests and in vitro diagnostics generally.
...

Read More

Eye on FDA

March 24, 2025

In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three
new initiatives related to food safety and food supply chain transparency. Outlined below, these new initiatives align with HHS Secretary Robert F. Kennedy
Jr.’s recent announcements to focus on bolstering food safety, including the recent directive to the FDA to explore the revision of the longstanding Generally
Recognized as Safe (GRAS) rule.
...

Read More

© 2025 Akin Gump Strauss Hauer & Feld LLP. All rights reserved. Attorney advertising. This document is distributed for informational use only; it does not constitute legal advice and should not be used as such. Prior results do not guarantee a similar outcome. Akin is the practicing name of Akin Gump LLP, a New York limited liability partnership authorized and regulated by the Solicitors Regulation Authority under number 267321. A list of the partners is available for inspection at Eighth Floor, Ten Bishops Square, London E1 6EG. For more information about Akin Gump LLP, Akin Gump Strauss Hauer & Feld LLP and other associated entities under which the Akin Gump network operates worldwide, please see our Legal Notices page.