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. This amendment allowed sponsors with low or moderate risk devices to proactively employ the De Novo process.
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