On September 9, 2019, FDA issued guidance for industry and FDA staff explaining FDA’s acceptance review process for De Novo classification requests. Although the acceptance review process does not evaluate the quality of a De Novo request, it is structured to facilitate substantive review by ensuring that the De Novo request is administratively complete. FDA should conduct and complete the acceptance review process within 15 calendar days of receiving the De Novo request. Requests that are not reviewed for acceptance within the 15-day window are considered to be under substantive review.
To assess whether a De Novo request contains the information necessary for a substantive review, FDA has established an “Acceptance Checklist.” The Checklist, which is provided as Appendix A to the Guidance, includes several preliminary questions, e.g., whether the product is a device or a combination product with a device constituent part, followed by checklists for assessing the completeness of the De Novo request. FDA will not consider a criterion in the Checklist to be “present” if the request fails to include either the requested information or a rationale for the omission or deviation.
Requests for combination products containing an approved drug as a constituent part should include, for each relevant patent, certification that (i) such patent information has not been filed, (ii) the patent has expired, (iii) the date on which the patent will expire, or (iv) the patent is invalid or will not be infringed (i.e., a paragraph iv certification). Requesters submitting a paragraph iv certification should also certify that they will provide notice of the certification to the patent owner(s) and holder of the approved application.
The Guidance includes as Appendix B a “Recommended Content Checklist.” Although the items in this list are not considered during the acceptance review process, requests that do not include the information may be more likely to be placed on hold or declined during substantive review.
Once the acceptance review process is complete, the request will receive an “accept” or “refuse to accept” designation. Applicants should be electronically notified of the status of their request within the 15-day period, after which, accepted applications will undergo the substantive review process. Notification of a “refuse to accept” designation should be accompanied by a completed Acceptance Checklist indicating the missing elements that prompted the designation.