Susan D. Tiedy-Stevenson
Senior Director of Regulatory Sciences
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.
Areas of Focus
Obtained the first HPV test for cervical cancer and continued to secure additional FDA approvals for HPV assays *
Secured the FDA's first ever Clinical Laboratory Improvement Amendments (CLIA) waiver approval for doctor office syphilis testing.
Obtained PMA approval and 510(k) clearances for a variety of medical devices.
Trained companies and entrepreneurs on FDA premarketing and CLIA waiver submission requirements.
*Matter handled prior to joining Hogan Lovells.