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.
- Which there is no legally marketed predicate device.
- De novo classification is a risk-based classification process.
- Devices that are classified as I or II may be marketed and used as a predicate for future premarket notification submissions 510 (k).
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
- Act as your US Agent
- Gap Analysis of your Device (Classify product according to FDA regulations)
- Submit Denovo Request to FDA
- Prepare the Denovo Request to FDA
- Prepare & Submit Small Business Fee Waiver to FDA
- Prepare Denovo Submission to FDA
- Submit Denovo Submission to FDA