Susan D. Tiedy-Stevenson
Senior Director of Regulatory Sciences
Washington, D.C.
Practice Group
Regulatory
Susan Tiedy-Stevenson assists clients in obtaining FDA marketing approvals and clearances for diagnostic tests and medical devices. She works with clients throughout the life cycle of product development in assessing FDA quality system requirements, clinical and analytical development, and implementation of post-marketing strategies. Susan is attuned to the needs of large corporations and start-up companies in formulating practical solutions to address FDA regulatory requirements.
She has deep insight into the FDA's biologics and medical device regulation of in vitro diagnostics (IVD) assays and related instruments, accessories, laboratory developed tests, and drug companion diagnostics. Susan also assists clients concerning FDA regulation of non-IVD medical devices including, in part, diabetes diagnostic and treatment devices and standalone software diagnostic applications.
Previously, Susan held executive management positions in regulatory, clinical, and quality for IVD, medical device, and biologic product companies and was responsible for preclinical and clinical study programs, development of regulatory strategies and premarketing submissions to the FDA and international authorities, and establishment and monitoring of good manufacturing practice programs compliant with FDA regulations.
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*Matter handled prior to joining Hogan Lovells.
Latest thinking and events
Hogan Lovells Publications
FDA Finalizes Guidances for Blood Glucose Meters
Medical Device AlertHogan Lovells Publications
FDA and CMS Make Case Before Congress for FDA Oversight of Laboratory Developed Tests
Medical Device AlertHogan Lovells Publications
FDA Holds Workshop on Proposed Regulatory Framework for Laboratory Developed Tests
Medical Device AlertHogan Lovells Publications
FDA Issues Final Guidance Regarding In Vitro Companion Diagnostic Devices
Medical Device AlertView More
