Subject: Docket FDA-2018-N-0236 Proposed Rule: Medical Device De Novo
Classification Process.
Dear Dr. Gottlieb,
The American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons
(CNS) appreciate the opportunity to provide our comments on the Food and Drug Administration’s
(FDA’s) recently released proposed regulation entitled Medical Device De Novo Classification Process.
Neurosurgery has a long history of collaboration with the agency, as our specialty, highly dependent on
medical technology, is one of rapid innovation. We share the common goal of improving patient safety
while enhancing efficiency in bringing lifesaving improvements to our patients.
Improvements in the De Novo Process
We commend the agency for publishing the proposed regulation to undertake a comprehensive
approach to strengthen and clarify the De Novo pathway through formal rulemaking. We appreciate the
fact that the FDA no longer requires a manufacturer to first submit and receive a denial for a 510(k)
application in order to access the De Novo process, if they can show that there is no legally marketed
device to use as a predicate. This makes sense and is much more efficient than the former prerequisite
to submit a 510(k) application and wait for a denial because of the lack of a substantially equivalent
device before being permitted to apply as a De Novo device. We support the agency’s work to develop
multiple pathways for products to come to market to address patient needs. A more effective De Novo
path will help create modern and useful predicate devices to give patients timely access to safe and
effective medical devices to improve their health.
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