Recent changes to the Food and Drug Administration Modernization Act of 1997 have facilitated the review and approval of novel devices. The process of classification of the de novo mechanism is one such change.
As such, device manufacturers should understand what a de novo classification is, the circumstances under which its use is appropriate, and scenarios under which device manufacturers can obtain a de novo classification.
What Is a De Novo Classification?
As part of the Food and Drug Administration Modernization Act of 1997, the de novo classification pathway functions as an alternative means of classifying low- to moderate-risk devices. Traditionally, these devices were automatically classified as class III devices after the Food and Drug Administration determined that they are not substantially equivalent during review of a 510(k) application.
However, according to a 2012 amendment of section 513(f)2 of the Federal Food, Drug, and Cosmetic Act, device manufacturers can apply for a de novo classification for a low- to moderate-risk device without submitting a 510(k).
For What Devices Is a De Novo Classification Appropriate?
The Food and Drug Administration considers the de novo classification to be appropriate for devices that have not been classified under section 513(a)(1) of the Federal Food, Drug, and Cosmetic Act. These devices do not fit into any particular class, have no equivalent device that is currently marketed, or have not been determined to be substantially equivalent as the result of a 510(k) application.
In addition, the device has to be low-to moderate-risk and meet all the requirements for classification as a class I or II device. The device manufacturer should also be able to explain all the risks and benefits, how the risks can be decreased, and how efficacy can be ensured through appropriate checks and balances.
Scenarios Under Which a Device Manufacturer Can Obtain a De Novo Classification
There are two scenarios under which a device manufacturer can obtain a 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 device on the basis of its risks.
Under 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 whether the de novo process is appropriate. If the de novo mechanism is appropriate, the Food and Drug Administration provides information on the documentation necessary to submit a de novo application.
Approval of a device via this scenario depends on whether the device manufacturer has conducted an effective search for an equivalent currently-marketed device, determined the risks and identified mechanisms to decrease such risks, and collected enough data for the Food and Drug Administration to determine its safety and efficacy.
Under the second scenario, a company can obtain a de novo classification by requesting it within thirty days after the Food and Drug Administration has determined that the device is not substantially equivalent. If there is no substantially equivalent device upon which to make a determination, the sponsor can ask the Food and Drug Administration to determine whether the mechanism is appropriate without submitting a 510(k) application.
For novel devices that would be considered low- to moderate-risk, and for which no substantially equivalent device is available, the de novo classification may be a viable option for companies who wish to market their devices without submitting a 510(k) application.