Administrative/Regulatory
Nov. 2, 2020
FDA proposes rule clarifying evidence for determining product’s intended use
Recently, the U.S. Food and Drug Administration issued a statement and proposed rule clarifying the types of evidence that the FDA considers when determining the “intended use” of a product. Intended use is important because it determines whether, and how, a product is regulated by the agency.
David M. Hoffmeister
Partner
Wilson Sonsini Goodrich & Rosati PC
David plays a major leadership role in the firm's drug and device regulatory and health care law practice and brings more than 25 years of experience in drug and device regulatory and health care law. David was named as one of the "25 Leading Biotech Attorneys" in California in 2011 by the Daily Journal, and is recognized as one of the leading food and drug regulatory lawyers in the country.
James R. Ravitz
Partner
Jamie was a partner in Wilson Sonsini's life sciences practice, representing manufacturers and distributors of products regulated by the FDA, including medical devices, drugs, biologics, food, cannabis, dietary supplements, and cosmetic products. Before joining the firm, Jamie led the FDA and health care life sciences practice at Arent Fox in Washington.
Georgia C. Ravitz
Georgia was a partner in Wilson, Sonsini, Goodrich & Rosati PC's life sciences practice, where she specializes in FDA regulatory, health care, and consumer products innovation and compliance. Prior to joining the firm, Georgia was a senior partner in the FDA and advertising practices of Arent Fox in Washington, D.C., where she led the firm's consumer product safety practice.
Charles Andres
Senior counsel
Wilson Sonsini Goodrich & Rosati PC
Charles is senior counsel in the firm's Patents and Innovations Strategies practice and the firm's U.S. Food and Drug Administration, Healthcare, and Consumer Products Compliance practice.
Recently, the U.S. Food and Drug Administration issued a statement and proposed rule clarifying the types of evidence that the FDA considers when determining the "intended use" of a product. Intended use is important because it determines whether, and how, a product is regulated by the agency.
There are several ways in which product manufacturers can run afoul of the FDA (and other agencies like the Federal Trade Commission and the ...
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