Washington, D.C. – Sidley Austin LLP announced today that Nancy K. Stade has joined the firm in Washington, D.C. as a partner in its Food, Drug and Medical Device Regulatory practice. Ms. Stade joins Sidley from the Food and Drug Administration (FDA) where she served for more than 15 years and held multiple high-level policy positions, most recently that of counselor in the Office of the Commissioner.
Ms. Stade brings to Sidley extensive experience in medical device regulatory law and first-hand knowledge of how the FDA develops policy. During her tenure with the FDA, Ms. Stade led many high-profile legislative and regulatory initiatives in areas on the leading edge of health technology, including clinical diagnostic tests, digital health, health IT and combination products. She also oversaw the development and implementation of the FDA’s device regulatory policy and has deep knowledge of device jurisdiction, substantial equivalence and classification.
“Nancy’s hands-on experience in FDA policy development and her comprehensive knowledge of medical device regulation will benefit our clients immensely,” said Mark Hopson, managing partner of Sidley’s Washington, D.C. office. “The vast knowledge she’s gained through many years of service with the FDA will allow her to immediately step in and add value.”
Ms. Stade served for five years as the Center for Devices and Radiological Health lead on all legislative, Government Accountability Office and administration oversight matters, which included playing a lead advisory role in developing the FDA Safety and Innovation Act device reform legislation.
“Nancy's extensive regulatory-law experience will be a tremendous asset to our clients, particularly as it relates to diagnostics, digital health and combination product regulatory matters,” said Coleen Klasmeier, leader of Sidley’s Food, Drug and Medical Device Regulatory practice. “Understanding not just what the law is but how FDA policy is made is increasingly critical to our clients. Nancy’s background will be invaluable.”
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