
The De Novo process was introduced by the FDA for instances where a novel device has no suitable predicate device to support a standard 510(k) submission. To qualify for the De Novo pathway, the new device must also present no more than moderate risk. The De Novo approval would result in the device being classified with special controls; it could then serve as a predicate device for future 510(k) applications.
“This new strategy is an important step toward bringing a non-invasive, non-radiation option to patients in the US suffering with prostate disease as quickly as possible,” said Jessica Foley, PhD, the Foundation’s Chief Scientific Officer. “A positive decision could potentially support a new pathway for some future focused ultrasound indications.”
This news has been covered in Med Page Today, Street Insider, and CNN Money.