Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Devices Track
Presenter
Dianna Kenner-Staves, PharmD
Consumer Safety Officer
Postmarket and Consumer Branch
Division of Industry and Consumer Education (DICE)
Office of Communication and Education (OCE)
Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration (FDA)
Dianna Kenner-Staves is a Consumer Safety Officer (CSO) in the Division of Industry and Consumer Education (DICE) in CDRH’s Office of Communication and Education (OCE). In her role as a CSO, she assists with DICE’s efforts to educate the medical device and radiological health industry on FDA regulatory requirements for marketing medical devices and radiation-emitting products. She uses the latest regulatory information to develop and maintain educational content on CDRH’s Device Advice webpages.
Prior to joining the FDA, Dianna worked as a clinical pharmacist at the VA Northern California Healthcare System, serving our nation’s military veterans. In her role as a pharmacist for the Veterans Health Administration (VHA), she worked directly with patients and their caregivers to provide comprehensive education about their medication regimens. Additionally, she provided patient counseling services which often included demonstrating the use of combination products, such as drug products contained in and administered by a medical device. Before beginning her career as a pharmacist, she served in the United States Air Force as a Cryptologic Language Analyst and provided translation services to military leaders. Dianna earned her Doctor of Pharmacy degree from the University of Maryland School of Pharmacy and is a licensed pharmacist in Maryland and Delaware.
Abstract
Dianna Kenner-Staves presents on Medical Device Reporting (MDR), outlining requirements for mandatory reporters: manufacturers, importers, and device user facilities, emphasizing that physician offices are not included. A reportable event is defined as one reasonably suggesting a marketed device caused or contributed to a death or serious injury, or a malfunction likely to do so if it recurs. Mandatory reporters must investigate such events. Manufacturers and importers generally report deaths, serious injuries, and malfunctions within 30 days, while user facilities report within 10 workdays. Manufacturers have a shorter 5-workday deadline for events requiring remedial action. Electronic submissions (eMDRs) are mandatory for manufacturers and importers. MDRs are crucial for detecting device-related safety issues, contributing to risk/benefit analysis, and potentially initiating FDA actions like inspections or recalls. An effective reporting system includes detection, documentation, investigation, and timely reporting. While incomplete reports are accepted, reporters must document efforts to get missing information and submit supplemental reports when new details become available. Devices legally marketed in the US with adverse events occurring overseas are reportable. FDA encourages robust reporting to build data for monitoring device performance and enhancing patient safety, making aggregated data available in the Maude database.