Device Classification Under Section 513(f)(2)(De Novo)

In 1997, the Food and Drug Administration Modernization Act (FDAMA) added the De Novo classification pathway under Section 513(f)(2) of the FD&C act, establishing an alternate pathway to classify new devices into class I or II that had automatically been placed in class III after receiving a Not Substantially Equivalent (NSE) determination in response to a 510(k) submission. In this process, a sponsor who receives an NSE determination may, within 30 days of receiving notice of the NSE determination, request FDA to make a risk-based classification of the device under section 513(a)(1) of the act.

In 2012, section 513(f)(2) of the FD&C act was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA), to provide a second option for De Novo Classification. In this second pathway, a sponsor who determines that there is no legally marketed device upon which to base a determination of Substantial Equivalence may request FDA to make a risk-based classification of the device under section 513(a)(1) of the act without first submitting a 510(k).

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