Long Time Passing: Where Have All the De Novo Decision Summaries Gone?
FDA Law Blog
AUGUST 18, 2024
By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Gibbs — In 1997, Congress wisely amended the Federal Food, Drug, and Cosmetic Act (FDCA) by adding Section 513(f)(2) to establish the De Novo process. The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use.
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