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FDA's final rule on LDTs: What this means for laboratories
This webinar will provide an overview of FDA’s final rule to regulate LDTs as medical devices. Regulatory attorney Christine Bump will review the timeframe under which laboratories have to comply with FDA’s device regulations and the types of tests that are exempt from one or more requirements. She will clarify what laboratories should do to maintain the regulatory status of exempted tests. Finally, Christine will discuss the costs of complying with FDA’s regulations and the systems, processes, and resources that may help laboratories best ensure operations under FDA’s jurisdiction.
Key takeaways
- Learn which laboratories are now considered device manufacturers by FDA.
- Learn which FDA device requirements laboratories must understand to determine whether any of the tests they develop or perform are subject to any exceptions under the final rule.
- Learn how laboratories can begin preparations to comply with at least Stage 1 of the phaseout policy under the final rule.
- Find out what processes and systems laboratories need to plan and budget for to comply with FDA’s device requirements.
Christine P. Bump, principal and founder of Penn Avenue Law & Policy, is an insightful regulatory attorney with 20 years of experience developing and implementing FDA strategies for devices, diagnostics, digital health platforms, and genetic and genomic tests. She advises laboratories, large corporations, and emerging companies with an awareness and understanding of their business and strategic goals.
Christine has served as regulatory counsel for a national diagnostic coalition, written several articles, and presented at numerous industry conferences. Before starting her firm, she practiced at Hyman, Phelps, & McNamara, P.C. and in the Life Sciences group at Goodwin. Christine earned a B.A. from Sweet Briar College, an M.P.H. from Emory University’s Rollins School of Public Health, and a J.D. from Emory University School of Law.