FDA Wants to Change the De Novo Pathway

Last week, FDA revealed plans to modernize the 510(k) clearance pathway, which was adopted in 1976 and now accounts for the majority of medical devices the agency reviews. This week, the agency has turned its attention to the de novo pathway for medical devices. The de novo pathway is used for the review of novel, low to moderate risk devices for which general controls, or general and special controls, provide a reasonable assurance of safety and effectiveness, but for which there is no existing predicate to use to determine substantial equivalence. According to FDA Commissioner Scott Gottlieb, MD, the de novo pathway for novel medical devices allows the agency to review new technologies so that patients have timely access to safe and effective devices t...

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