Glossary Term
De Novo Classification Request
Definition
The De Novo Classification Request is a regulatory pathway provided by the U.S. FDA for novel medical devices that do not have a legally marketed predicate device. It allows manufacturers to request classification of their device as Class I or Class II, based on reasonable assurance of safety and effectiveness, instead of being automatically classified as Class III.
Relevance to the MedTech Industry
The De Novo pathway provides an opportunity for innovative medical devices to enter the market with appropriate regulatory controls tailored to their risk level. It fosters innovation by offering an alternative to the more stringent premarket approval (PMA) pathway for devices lacking a predicate.
Additional Information & Related Terms
510(k) Premarket Notification Devices classified through De Novo may become predicates for future 510(k) submissions.
Premarket Approval (PMA) An alternative pathway for high-risk devices requiring more rigorous data.
Risk Management File Integral to the De Novo submission, detailing how risks are mitigated.
FDA The regulatory body overseeing the De Novo pathway in the United States.