FDA De Novo Summaries: Updated List

For over 10 years, the United States’ Food and Drug Administration (FDA) has released summary documents for medical devices approved via the De Novo classification process – that is, “an objective and balanced summary of the scientific evidence that served as the basis for the decision to grant a De Novo request.”

The De Novo classification set out by the FDA is a risk-based pathway for the approval of new and novel medical devices onto the market, with two options for those technologies seen to be of low to moderate risk:

1. Where a Not Substantially Equivalent (NSE) determination is received in response to a 510(k) submission, within 30 days of receipt of the NSE determination a De Novo request can be submitted to the FDA for them to evaluate classification of the device into Class I or II based on risk; or
2. Where no legally marketed device exists that is deemed to be equivalent, a De Novo request can be submitted for the FDA to classify the device into Class I or II, without first presenting a 510(k) submission and receiving an NSE determination.

Check out the recently updated list of all available De Novo summary documents via the FDA website.