How long does it take FDA to review De Novo submissions?

The new FDA goal is to review De Novo submissions within 150 calendar days for 70% of De Novo submissions, but how long does it take now?

If you would like more detailed information related to this video, please visit our blog posting discussing FDA timelines to review De Novo submissions:
➤ https://medicaldeviceacademy.com/revi...

If your firm is preparing a De Novo Submission, we include our De Novo templates and De Novo webinars as part of our 510(k) Course because 80% of the submission contents are identical for 510(k) submissions and De Novo submissions. You can learn more about the 510(k) course at:
➤ https://medicaldeviceacademy.com/510k...

Finally, if you are interested in discussing your De Novo submission with one of our consultants, please schedule a Zoom meeting using one of the calendly links provided below:
Rob Packard - https://calendly.com/13485cert/30min
Mary Vater - https://calendly.com/maryvater
Sharon Morrow - https://calendly.com/sharon-1211
Bhoomika Joyappa - https://calendly.com/bhoomika-joyappa

You can also contact our Director of Sales, Lindsey Walker: https://calendly.com/sales-lindsey