In the FDA, medical devices are classified into three categories (Class I, II, and III) based on their level of risk. A 510(k) pre-market notification must be submitted for Class II devices. This process involves demonstrating the substantial equivalence of the device to a legally marketed predicate device that has already received 510(k) clearance. After this submission, if the FDA determines that the device is "Not Substantially Equivalent" (NSE) to a predicate device, it automatically moves into Class III, requiring pre-market approval.
However, The Food and Drug Administration Modernization Act of 1997 (FDAMA) introduced the De Novo classification option as an alternative pathway for classifying novel medical devices. Section 513(f)(2) of the FD&C Act was amended by the Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012, allowing for the submission of a De Novo classification request to the FDA without the need for a prior 510(k) submission.
For the De Novo classification for novel devices for low to moderate risk, there are two options available:
Option 1: After receiving a "Not Substantially Equivalent" (NSE) determination for a 510(k) submission, within 30 days, the FDA can be requested to conduct a risk-based evaluation for classification of the device into Class I or II through a De Novo submission.
Option 2: If it is determined that there is no predicate device that can be demonstrated as substantially equivalent among marketed products, a 510(k) submission may be made without receiving an NSE determination. The FDA can then be requested to conduct a risk-based evaluation for the classification of the device into Class I or II through a De Novo submission.
The De Novo process allows for the classification of medical devices that can be marketed and can also serve as a predicate for future 510(k) submissions to demonstrate substantial equivalence.
Since 2010, the FDA has started releasing summary documents for devices classified through the De Novo process. These summary documents are created to provide objective and balanced scientific evidence that forms the basis for approving De Novo requests.
De Novo summaries also serve as a resource for manufacturers who intend to use the device as a predicate for demonstrating substantial equivalence in future 510(k) submissions.
You can find De Novo summary documents at the following link:
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