On October 5, 2021, the US FDA issued a final guidance for the Industry and Food and
Drug Administration Staff, which provides information on the process for submission
and review of a De Novo classification request under the section 513(f)(2) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act).
As noted in this document, due to the enactment by FDAMA, in order to submit a De
Novo request, a device first had to demonstrate that it is non substantially equivalent
(NSE) to its legally-marketed predicate devices through a premarket notification (510(k))
process. Further, the 21st Century Cures Act removed the requirement which obligated
that a De Novo request must be submitted within 30 days of its receiving an NSE
determination. This guidance strongly recommends a Presubmission prior to the
submission of a De Novo request, especially for those devices which have not
previously been reviewed under a 510(k) notification process. Further, the guidance
provides information for the Presubmission substantive review and regarding when a De
Novo Classification Process ‘May’ and ‘May Not Be Used’.
Overall, this guidance has provided immense clarity for the De Novo process which is a
pathway to Class I or Class II classification for medical devices which apply general
controls, or general and special controls, and are required to provide a reasonable
assurance of safety and effectiveness (S&E) requirements, but for which there is no
legally marketed predicate device.
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