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 the link provided. De Novo Classification Process

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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