Recent changes to the Food and Drug Administration Modernization Act of 1997 have made it easier to review and approve new devices. The FDA De Novo mechanism classification process is one such change. Therefore, device manufacturers need to understand what the de novo classification is when it is appropriate to use it, and the scenarios in which the device manufacturer can obtain the de novo classification.
What is the De novo classification?
The FDA De Novo classification pathway serves as an alternative to classify low-risk to medium-risk devices. Traditionally, these devices were automatically classified as Class III devices after the Food and Drug Administration determined during a review of the 510 (k) applications that they were not substantially equivalent.
Suitability of the De Novo classification
The Food and Drug Administration believes that the FDA De Novo classification is appropriate for devices that are not classified under Section 513 (a) (1) of the Federal Food, Drug, and Cosmetic Act. These devices have not been determined to fit a particular class, have no equivalent devices currently on the market, or are virtually equivalent as a result of the 510 (k) application.
In addition, the device must be low-risk to medium-risk and meet all the requirements to be classified as a Class I or II devices. The device manufacturer must also be able to explain all the risks and benefits, how to mitigate the risks, and how to ensure effectiveness by proper checking and balancing.
How device manufacturers can get the FDA De Novo classification?
There are two scenarios in which device manufacturers can obtain the de novo classification. In both cases, the company must ask the Food and Drug Administration to evaluate whether the device is a Class I or II devices based on risk.
In the first scenario, the device manufacturer submits a pre-submission to the Food and Drug Administration. The Food and Drug Administration then provides feedback on the appropriateness of the de novo process. If the FDA De Novo mechanism is appropriate, the Food and Drug Administration will provide information on the documents required to file a de novo application.
Device approval in this scenario allows the device manufacturer to effectively search for comparable, currently-sold devices, identify risks, and identify mechanisms to mitigate such risks and the Food and Drug Administration to the device. It depends on whether you have collected enough data to identify safety and effectiveness.
After the Food and Drug Administration determines that the devices are not substantially equivalent, an entity can obtain an FDA De Novo classification by requesting within 30 days. In the absence of a substantially equivalent device to make a decision, Sponsor may ask the Food and Drug Administration to determine if the mechanism is appropriate without filing a 510 (k) application. I can do it.
For new devices that are considered low to medium risk and for which virtually equivalent devices are not available, FDA De Novo classification is a viable option for companies that want to sell their devices without submitting a 510 (k) application.
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