Where Have All the De Novo Summaries Gone: An Update
FDA Law Blog
SEPTEMBER 3, 2024
By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Gibbs — Thank you to readers of this blog. We received incredible feedback on our August 19 post analyzing the number of decision summaries that have been posted for De Novos. We are happy to report that fifteen new decision summaries have been posted as of August 28. Notably, two decision summaries were posted for De Novos that had been granted in 2020 and two were posted for De Novos granted this year.
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