Background
Dr. Griffin is a trained molecular microbiologist with over 6 years of FDA experience and 10 years of research experience focused on different aspects of virulence and pathogenesis of various bacterial pathogens. She has extensive knowledge in infectious disease, diagnostics, including but not limited to detection of pathogenic organisms as well as antimicrobial susceptibility testing. While working at FDA, Dr. Griffin contributed to the development of policies and guidance, particularly as it pertained to antimicrobial susceptibility testing, as well as served on numerous committees and working groups within the Clinical and Laboratory Standards Institute to assist in the revision and development of critical laboratory standard documents.
Education
Dr. Griffin received her Bachelor of Science in Molecular and Cellular Biology at the University of Illinois, Urbana-Champaign and her Ph.D. in Molecular and Cellular Biology at Arizona State University.
Experience
Prior to joining MCRA, Dr. Griffin worked in the Division of Microbiology Devices at the FDA for six years, first as a lead reviewer and then as a Team Lead. During her tenure, Dr. Griffin conducted and oversaw the scientific and regulatory review of hundreds of premarket applications submitted to FDA, including 510(k), 513(g), Breakthrough Designation, Emergency Use Authorization (EUA), pre-EUA, and Pre-submissions, while also consulting on numerous post-market/compliance activities. While Dr. Griffin specialized in the review of antimicrobial susceptibility testing devices and developed streamlined processes for regulatory review
and least burdensome validation approaches for device developers, she also led and coordinated the review for various microbiology-related in vitro diagnostic devices, including devices for the detection of respiratory, gastrointestinal, and blood-borne pathogenic organisms as well as for the detection of antimicrobial resistance (AMR) markers using culture dependent and culture-independent (i.e., direct from specimen) sample types. Across the device types, Dr. Griffin reviewed numerous devices with novel technologies and paradigm-shifting applications, as well as devices intended for use in CLIA-waived settings and over-the-counter.
While at FDA, Dr. Griffin also participated in and led groups with goals to support the FDA’s mission to promote and protect public health by streamlining efforts for device development and regulatory authorization as well as supporting the FDA’s mission to collaborate, coordinate and emphasize AMR-related efforts. In addition, she served numerous roles in the Clinical and Laboratory Standards Institute, including as an adviser to both the antimicrobial and antifungal subcommittees and member on document development committees.
Prior to joining FDA, Dr. Griffin did back-to-back postdoctoral research at the University of Nevada Las Vegas and the University of Florida, focusing on virulence gene regulation in bacterial pathogens.
Overview
Dr. Griffin brings her in vitro diagnostics regulatory expertise to MCRA’s FDA & Global Regulatory department. Within the In Vitro Diagnostics Regulatory Affairs group, Dr. Griffin focuses on supporting the strategic direction and business development of the IVD Regulatory team, as well as developing and executing regulatory services for client companies. While her primary focus is to support premarket efforts by informing on regulatory strategy and development of medical devices through design and review of analytical and clinical testing, Dr. Griffin collaborates with other MCRA departments, including reimbursement and quality assurance, to ensure that client companies receive comprehensive guidance regarding all aspects of the commercialization of their products.