FDA Special Program: Denovo Registration for Medical Devices

Overview of Denovo Process

Denovo definition

De Novo is a classification process that uses a risk-based strategy to down classify new Class III medical device into Class II or Class I because there is no legally marketed predicate device on the market.

If you said yes to all or some of the conditions, you may qualify for this program

what are the Main Advantages of Denovo program?

1. No FDA User Fees

2. Reduced FDA review timelines

Review reduced from 360 days to 120 days

3. No Annual reporting

Check out GRP Presentation on the subject

GRP Denovo request Services