In a previous post, I mentioned the Bose Hearing Aid was approved by CDRH under the De Novo Classification Request process. This process allows CDRH to grant premarket approval for new devices for which there is no legally marketed predicate device as a newly classified Class I or II device using a risk-based evaluation. Sponsors may submit a De Novo request either after receiving a determination that their device is not substantially equivalent (NSE) or without first submitting a 510(k) application for their device. CDRH does recommend that sponsors use the Q-Sub program to obtain feedback from the appropriate pre-market approval agency before submitting a De Novo request. More details, including what should be in the submission, how the agency will perform the review, and links to relevant guidance are available on the main De Novo web page.
De Novo requests are subject to a user fee, are assigned a special identifier for the program (with the format DEN######) and have their own review timeline. The granting of a De Novo request establishes a category of predicate device and a new classification regulation. The FDA publishes the granting orders and classification summaries here aand the regulation is published in the Federal Register (see an example for the positive airway pressure delivery system here). You can look up the summary for any device classified under Section 513(f)(2) [the Food, Drug, and Cosmetics Act regulation for the De Novo program] here.
Text Copyright © 2018 Katrina Rogers