Where Have All the De Novo Summaries Gone: An Update

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. Thus, the new summaries bracket a wide range in time.

Some other noteworthy observations:

• More than half (8/15) of the recently posted decision summaries were from 2023.
• There were no new summaries published for De Novos granted in 2021.
• The leader, with five summaries, was OHT7. OHT1 earned the silver medal with its four summaries.
• Not counting the two recent De Novo decisions that were not part of the original analysis, the total number of decision summaries posted for De Novos granted between CY 2022 and 2024 YTD is now 45/101 (43%). This represents an improvement, but there are still lots of De Novos for which the summaries are not yet available.
• On our list of the Top Ten De Novos with the greatest number of days elapsed between when they were granted and the lack of a decision summary, seven now have decision summaries posted for them.

We are cautiously optimistic more decision summaries will be posted soon. Given the high rate of innovation in the device industry, including the evolving field of AI, we expect more manufacturers to either submit De Novo classification requests or rely on those for their 510(k) devices. Timely access to these decision summaries will help manufacturers, FDA, and provide greater transparency to the public.