On October 30, 2017 the FDA issued a final guidance Document detailing the De Novo submission and review process. Entitled “De Novo Classification Process (Evaluation of Automatic Class III Designation)”. The final document supersedes the August 14, 2014 draft and coincides with increased recognition on the utility and rapid adoption of this review pathway by both the industry and the Agency. A De Novo request is a type of premarket authorization where the sponsor asks that a device be classified into Class I or II and is intended for those devices that were automatically classified into Class III due to lack of a clear predicate device via the 510(k) process. If successfully adopted, the result is a new classification regulation for the new device.
The final guidance culminates an evolution that started in 1997 with the creation the De Novo process review where a device found Not Substantially Equivalent (NSE) could be reviewed for reclassification if filed within 30 days of the decision date. Through various modifications, the need for an NSE was dropped and a direct De Novo request added. More recently De Novo requests have been adopted into the FDA user fee structure.
The final guidance specifically addresses the following aspects of the process:
- Detailed how eligibility for inclusion into the program is determined for a device
- The integration of the Pre-Submission process for De Novo determinations
- Recommended De Novo content
- Review guidelines and granting De Novo order