De Novo vs 510k - What’s the difference

There are four differences between a De Novo application and a 510(k) submission, not including time or money.

What is a De Novo application?
A De Novo application is the FDA regulatory pathway for any medical device that does not have equivalent indications for use and equivalent technological characteristics when compared to another device that is already legally marketed in the USA.

Why are you afraid of a De Novo?
Investors and companies alike try to avoid De Novo applications in favor of 510(k) submissions. The reasons given are usually time and money, but neither of these factors is significantly different.

What are the $ and time differences?
The relative time required for granting a De Novo application is 150 days while 510(k) clearance requires 90 days. In comparison, both types of submissions frequently experience delays of 180 days when companies fail to complete all of the required testing prior to submission. The relative cost of these two submission types differs by ~$25,000, but this difference typically represents 5% of the total development cost. Therefore, the difference between the target review timelines and FDA user fees should not be major reason for companies and investors to avoid a De Novo application.

Related Blogs/Pages on our Website
➤ https://medicaldeviceacademy.com/clas...
➤ https://medicaldeviceacademy.com/de-n...
➤ https://medicaldeviceacademy.com/de-n...
➤ https://medicaldeviceacademy.com/de-n...

Timestamps
0:00 Intro Animation
0:08 Hello Alysha
0:17 Today's Topic - De Novo vs 510(k)
1:00 We digress
1:35 Searching our website for De Novo content
2:24 The 4 differences are not $ or time
3:19 What is the difference in $?
4:33 What is the difference in time?
6:06 What are the 4 differences?
7:44 Alternative practices and procedures
9:48 Classification summary
16:00 Classification information and supporting data
19:57 Benefit/risk analysis
24:15 Don't be afraid of a De Novo, make history
25:45 Not all De Novo applications require clinical data
26:16 Is your device a De Novo or a 510(k)?

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