Overview
The De Novo Medical Devices process allows the Food and Drug Administration (FDA) to classify a medical device when the applicant cannot find a legally marketed predicate device. Generally, the US FDA assesses the safety and efficacy for the intended use of new medical devices to provide reasonable assurance of user rights [1].
FDA Regulations
Under the original FDA Modernization Act of 1997 (FDAMA), new medical devices are automatically placed in Class III if the device receives a "not substantially equivalent (NSE)" determination from the FDA.
However, the FDA Safety and Innovation Act of 2012 (FDASIA) permits De Novo classification requests to the FDA without first submitting a 510(k). If the new devices are low to moderate risk products, there are two options for the De Novo classification:
- When an applicant receives an NSE determination following a 510(k) submission, they may submit a De Novo application for the medical device within 30 days. The FDA will conduct a risk-based assessment to classify the device as Class I or Class II.
- Directly submit a De Novo request to the FDA without first submitting a 510(k), if there is no legally marketed device to base a substantial equivalence determination.
The applicant may re-submit their De Novo application if the FDA determines the NSE. They can modify and submit the application for registration to the FDA within the deadline to save time [2].
The FDA intends to use the De Novo process to expand the existing 510(k) database of predicate products and to enhance the current classification system. This approach aims to facilitate and improve future 510(k) submissions [3].
Additional Resources
Type Approval Impacted
Medical
Approval Process Impact
Yes
Importation Process Impact
N.A
Type of Product Impacted
Class III
Country
USA
Regulatory Impact
| Impact Type | Status |
|---|---|
| Top Priority | |
| Type Certificate | |
| Spectrum Bands | |
| Import Changes (HS Codes) | |
| Standard Changes | |
| Product Changes | |
| Label Changes |