Dr. Brent Showalter is currently the Acting Assistant Director for the Division of Spinal Devices at the FDA. This division regulates devices such as pedicle screws, cages, and total disc replacements. Prior to joining the FDA, Dr. Showalter studied intervertebral disc mechanics at the University of Pennsylvania and received a bachelor’s in mechanical engineering from Brigham Young University. He will be speaking at our Graduate Seminar at 4:00 PM in room 256 CB.
The Center for Devices and Radiological Health (CDRH) within the U.S. Food and Drug Administration (FDA) works to ensure that patients have timely access to safe, effective, and high-quality medical devices. CDRH accomplishes this by advancing regulatory science and working to provide the medical device industry with predictable, consistent, and efficient regulatory pathways. Examples of this work include recent device approvals for pediatric patients with spinal deformities, the development and publishing of a draft guidance document for MR safety testing of medical devices, and published considerations for devices that are additively manufactured.