The De Novo pathway is used to review new, low-to-moderate risk devices and determine predicates that assure certain safety and effectiveness measures.
The regulatory agency have published the new de novo Classification Proposed Rule involving procedures and criteria associated with the process. The rule is intended to enable ‘appropriate’ classification of new types of medical devices.
Specifically, the revision offers structure, clarity and transparency on the format and content of de novo requests, and the processes and requirements for acceptance, declining and withdrawal of the requests.
