New 510(k) Modification Guide May Expose Industry To Off-Label Litigation

August 19, 2016 at 3:18 PM
A new draft FDA guidance could make device companies vulnerable to off-label litigation by providing specific examples of when the government can charge them with a failure to have a new 510(k) for a modification to an existing device, and “criminalizing what has traditionally been considered a regulatory violation,” following a spate of agency losses on First Amendment grounds, suggest industry lawyers. Hyman, Phelps & McNamara's FDA Law Blog cited a history of FDA disputing companies' interpretation of when a...


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