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FDA issues final guidance and checklists for de novo submissions

  • Posted by: inetika
  • Category: GLOBAL NEWS

A final version of the draft document issued in October 2017 relating to US Food and Drug Administration (FDA) acceptance of de novo submissions has now been issued by the Agency. Titled ‘Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff’, 9 September 2019, it explains the procedures and criteria FDA intends to use in assessing whether a request for evaluation of automatic class III designation devices (De Novo classification request) meets a minimum threshold of acceptability and should be accepted for substantive review. Copies of the final guidance can be obtained from here.

To enhance consistency, the document provides FDA staff with a clear, consistent approach to making “Accept” or “Refuse to Accept” (RTA) decisions on De Novo requests. The guidance includes both an Acceptance Checklist (Appendix A. Acceptance Checklist for De Novo Classification Requests) as well as a Recommended Content Checklist (Appendix B. Recommended Content Checklist for De Novo Classification Requests), which applicants should use to ensure all elements are included in the submission, so as to avoid a ‘RTA’ response, which will require additional information to be submitted, with a consequential time delay in the start of the agency’s substantive review process.

The De Novo requester may respond to a RTA notification by providing the missing information identified in the Acceptance Checklist. The De Novo requester should submit this information to the respective Center’s Document Control Center (DCC) to be included in the file under the originally assigned De Novo number. A new De Novo request and new user fee are not necessary, and it is not necessary to resend the entire De Novo request, unless FDA notes otherwise (e.g., because the De Novo request is missing the majority of the items on the checklist). It is sufficient to submit and address only the information requested per the Acceptance Checklist. If a response to the RTA notification is not received within 180 days of the date of RTA notification, FDA will consider the De Novo request to be withdrawn and the De Novo request will be closed in the system.  If FDA does not complete the acceptance review within the acceptance review period (i.e., within 15 calendar days of receipt), the De Novo requester should be electronically notified that the acceptance review was not completed and the De Novo request is now under substantive review.

The FDA review clock start date is the receipt date of the most recent De Novo request or additional information that resulted in an acceptance designation for the De Novo request, provided the user fee has been paid and a validated eCopy has been provided. The fee for a De Novo submission for financial year 2020 (which starts on 1 October 2019) is $102,299. The guidance document will apply from 30 October 2019.

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