EDAP-TMS is changing their US regulatory strategy to pursue direct De Novo 510(k) approval for their Ablatherm system to treat prostate cancer instead of continuing to pursue a Pre-Market Approval (PMA) application. The company made this decision based on discussions with the US Food and Drug Administration (FDA).
Marc Oczachowski, EDAP’s Chief Executive Officer commented that, “Pursuing a Direct De Novo 510(k) Petition is an opportunity for more expeditious clearance of Ablatherm HIFU technology in the United States. Our team is now diligently focused on preparing the De Novo application.”
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.”