The Food and Drug Administration Modernization Act of 1997 (FDAMA) included the De Novo classification option as an alternate pathway for classifying novel medical devices that had been automatically classified as Class III after receiving a “not substantially equivalent” (NSE) determination in response to a premarket notification [510(k)] submission. Section 513(f)(2) of the FD&C Act was revised to allow a sponsor to submit a De Novo classification request to the FDA without first submitting a 510(k). For innovative low- to moderate-risk device categorization, there are two choices.
- Anyone who obtains an NSE finding in response to a 510(k) submission may submit a De Novo request for the FDA to conduct a risk-based review for classification of the device into Class I or II within 30 days of receiving the NSE determination.
- Anyone who believes there isn’t a legally marketed device on which to base a finding of substantial equivalence may submit a de Novo request to the FDA, asking it to classify the device into Class I or II based on risk, without first submitting a 510(k) and waiting for an NSE determination.
Devices that are categorized via the de novo approach are allowed to be sold and used as predicates for 510(k) submissions in the future. The FDA started publishing summary sheets for devices categorized using the De Novo procedure in 2010. The objective and fair description of the scientific data used to support the decision to approve a De Novo request is the goal of the De Novo summary. Device makers who might want to utilize the device as the basis for further 510(k) submissions can consult the De Novo summary for more information on the kinds of evidence needed to prove significant equivalence.
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Source: Class III Designation (De Novo)
