Your product appears to be a first-of-its-kind device with moderate risk, which may make it a candidate for the De Novo pathway. This route is intended for novel medical devices that do not have a clear predicate but are not high-risk enough to require PMA. A successful De Novo submission creates a new classification for future similar devices. Be aware that you will need to conduct a clinical trial or IDE to support your DeNovo market application.
De Novo products typically carry a lower risk profile and can be regulated through general and special controls. Once cleared, they establish a brand-new product classification.
Some De Novo devices require clinical data if risk or performance cannot be validated through other forms of testing. However, it depends on novelty and intended use.
Schedule a free discovery call with our team to assess your innovation, confirm your classification, and build a focused FDA strategy.
