On October 5, 2021, the U.S. Food and Drug Administration (“FDA”) published a final rule to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act.

The final rule, which takes effect January 3, 2022, comes nearly three years after the FDA first proposed it and, notably, sets forth the procedures and criteria for a manufacturer’s voluntary submission and withdrawal of a De Novo request. Additionally, the rule clarifies how agency staff intends to accept and review the requests, as well as how FDA staff will determine whether to grant or decline the requests. Finally, the rule also provides a way for combination products to use the De Novo pathway.

Useful for novel, low risk medical devices

The implementation of the De Novo classification process is especially significant for manufacturers of novel, low-risk medical devices. Prior to the De Novo program, which was created in 1997, any device that lacked a predicate automatically became designated as a Class III device and, therefore, required premarket approval with a 510(k) submission to legally reach the market. Because this premarket pathway is designed to regulate the riskiest category of devices, manufacturers typically had to endure longer than anticipated wait times for approval of their low-risk devices.

Under the De Novo classification process these same manufacturers have an alternative and more efficient pathway for obtaining marketing authorization for their low-risk devices from the FDA. With this process, these devices can be classified as Class I devices (subject to general controls) or Class II devices (subject to both general and special controls). The new rule codifies the De Novo classification process that had previously been set forth in guidance documents and provides manufacturers with the required elements of a submission.

No 510(k) submission needed, can establish predicate

Under the new rule, a device manufacturer may submit a De Novo request (i) after submitting a 510(k) and receiving a “not substantially equivalent” determination from the FDA or (ii) without first submitting a 510(k) as long as the manufacturer determines that there is no legally marketed device upon which the FDA could base a determination of substantial equivalence.

As an added bonus, once the FDA classifies a device as Class I or Class II via the De Novo classification process, other manufacturers can use it as a predicate for a substantial equivalence determination under the premarket notification pathway, when applicable, to legally market their devices.

Taken together, the final rule’s new De Novo pathway and related requirements should help the FDA achieve its stated goal to limit the unnecessary expenditure of agency and industry resources that would otherwise occur if devices, for which either general controls or both general and special controls will provide a reasonable assurance of safety and effectiveness, were instead subject to the full 510(k) premarket approval process.