RE: More like 3-5p by next week26 Jan 2024 11:01
From Sterling Medical Devices.com dated February 2023
The FDA’s De Novo pathway for novel medical devices can be long and costly. In 2023, the fee for an FDA De Novo vs. 510(k) is significant – a De Novo classification request is $132,464, while the fee for a 510(k) is $19,870. In terms of timing for a 510(k) vs. De Novo submission, the difference is also considerable, with De Novo requests having a target review period of 150 days compared to 90 days for 510(k).