Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Devices Track
Presenter
Joseph Tartal
Deputy Director
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)
Joseph Tartal is Deputy Director of the Division of Industry and Consumer Education (DICE), Office of Communication and Education (OCE), in FDA’s Center for Devices and Radiological Health (CDRH). In this role, he directs the division’s effort to educate the medical device industry to understand its regulatory requirements and responsibilities with medical devices. Mr. Tartal serves as FDA faculty for the Association for the Advancement of Medical Instrumentation (AAMI) and is a member of the Regulatory Affairs Professionals Society (RAPS) education committee. Prior to his 18-year FDA career, Mr. Tartal served as a Quality Assurance Manager for small medical device manufacturers, primarily responsible for implementing and maintaining compliant quality management systems. He has over 30 years of experience in the medical device industry, including premarket submissions. Mr. Tartal received a bachelor’s degree in biology from Pennsylvania’s Slippery Rock University.
Abstract
Joseph Tartal provides an overview of the new Quality Management System Regulation (QMSR), which replaces the long-standing Quality System Regulation (QSR), 21 CFR Part 820. The final rule, published in February 2024, aims to harmonize U.S. requirements with international standards by incorporating by reference ISO 13485:2016. This update provides a two-year transition period, with the QMSR effective date being February 2, 2026. Manufacturers are encouraged to begin preparing now by reading the final rule and its preamble, which provides crucial context and FDA’s rationale, and familiarizing themselves with the standard. The QMSR retains the flexible scope of the current QSR but introduces changes in structure and definitions, establishing a hierarchy of definitions prioritizing the Food, Drug, and Cosmetic Act, then the regulation itself, and finally the incorporated standards. Key clarifications from the Q&A emphasize that FDA retains inspectional authority and will not issue ISO certificates, MDSAP will be updated, and FDA will now review internal audit and management review results as part of the QMS assessment. FDA plans to provide resources and education to support the transition.