This article deals with the classification of medical devices under the De Novo Pathway. Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De Novo classification option as an alternate pathway to classify novel medical devices that had automatically been placed in Class III after receiving a “not substantially equivalent” (NSE) determination in response to a premarket notification [510(k)] submission. On July 9, 2012, section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law amending section 513(f)(2) of the FD&C Act to permit 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 gets an NSE finding in response to a 510(k) submission has 30 days from the date of receipt of the NSE determination to submit a De Novo request to the FDA asking that the agency conduct a risk-based assessment to determine whether to classify the device as Class I or Class II.
- A De Novo request for the FDA to classify a device into Class I or II based on risk may be made by anyone who determines that there are no legally marketed devices on which to base a determination of substantial equivalence, 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: FDA.gov.uk
