Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Devices Track
Presenter
Tonya A. Wilbon
Branch Chief
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)
Tonya A. Wilbon is the Branch Chief for the Postmarket and Consumer Branch, Division of Industry and Consumer Education (DICE), Office of Communication and Education (OCE), Center for Devices and Radiological Health (CDRH). Tonya leads DICE’s efforts to educate and inform the medical device and radiological health industry on its FDA regulatory requirements for marketing medical devices and radiation-emitting products. In addition, she leads the division’s efforts to educate and inform consumers, health care professionals, and patients on issues with these medical devices and radiation-emitting products. Ms. Wilbon has been with FDA for over 24 years with more than 10 years of clinical laboratory experience. She initially began with the FDA as a Microbiology Scientific Reviewer for CDRH’s Office of In Vitro Diagnostics and Radiological Health (OIR) and served as the Quality System Specialist within OIR.
Ms. Wilbon also currently serves as an FDA instructor for the Association for the Advancement of Medical Instrumentation (AAMI) and serves on FDA’s Content Advisory Group as an instructor for FDA Investigators and Staff. Ms. Wilbon received a Bachelor of Science Degree in Microbiology from Howard University and is a certified Microbiologist by the American Society of Clinical Pathology (ASCP).
Abstract
Tanya A. Wilbon discusses the new Quality Management System Regulation (QMSR), which replaces the previous Quality System Regulation (QSR), 21 CFR Part 820. Effective February 2, 2026, the QMSR harmonizes U.S. requirements with international standards by incorporating by reference (IBR) ISO 13485:2016 and clause 3 of ISO 9000:2015. The regulation is restructured into two subparts, focusing on general provisions (Subpart A) and supplemental requirements for records and labeling/packaging (Subpart B). While incorporating standards, the QMSR establishes a hierarchy where FDA regulations and the Food, Drug, and Cosmetic Act supersede definitions in the standards. Manufacturers must also continue to comply with other applicable FDA regulations, such as UDI, device tracking, medical device reporting, and corrections/removals. Risk management is addressed as the incorporated standards emphasize risk-based decisions throughout the quality system. FDA is revising its inspection techniques, including updating the QSET program, to align with the new regulation. To prepare, manufacturers should review the final rule and its preamble, conduct a gap analysis of current procedures, implement identified changes, and train employees.