FDA Final De Novo Submission Guidance

The FDA release a final guidance, “De Novo Classification Process (Evaluation of Automatic Class III Designation),” on October 30, 2017. This supersedes “New Section 513(f)(2) – Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff” dated February 19, 1998. This guidance defines the process for De Novo submissions for devices with no predicate that previously would automatically have been considered Class III; provided there is not current classification rule for this type of device. This guidance clarifies that a 510(k) with an NSE determination is no longer required for De Novo submission. The guidance recommends but does not require a Pre-Sub review with FDA. The full guidance is at this link: De Novo Guidance.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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