The FDA finalized three guidance documents related to de novo classification requests for clearance when there is no predicate device for comparison.
In final guidance on its acceptance review for de novo classification requests, the FDA lays out its minimum threshold of acceptability to evaluate de novo requests for automatic Class III designations. The document provides an acceptance checklist for devicemakers and a recommended content checklist to use when submitting de novo requests.
The agency said that all elements identified as acceptance items should be included in the application to be deemed acceptable, or the devicemaker should justify why these items are not included in the application. The acceptance review should be conducted within 15 days for original de novo requests, and the agency clarified that acceptance reviews are conducted to assess whether de novo requests contain the needed information to conduct a substantive review.
The final guidance also includes preliminary questions to be answered by the agency’s lead reviewer to serve as an initial screening for the acceptability of the de novo request. Most of the questions cover whether the device is a combination product and which center should be conducting the review.
A second guidance covers the review clock and goals established under MDUFA IV. For de novo decisions, the review clock is set at 150 days. If a final decision has not been made within 180 days, the FDA will meet with the applicant to discuss any outstanding issues.
The third guidance covers user fees and refunds for do novo requests. The guidance discusses the types of de novo requests subject to user fees, exceptions to user fees and actions that may result in refunds of fees that have been paid.
Read the three guidances here: www.fdanews.com/09-12-19-Guidances.pdf.