The US Food and Drug Administration (FDA) classifies all medical devices based on the risks associated with the device. Novel devices that have not been previously classified, and that do not have the same intended use as other Class I or Class II devices on the market, are automatically deemed as Class III, the most highly regulated category.
This applies irrespective of the actual risks of the device or the ability of so-called general or special controls to provide reasonable assurance of safety and effectiveness. However, as a part of the FDA Modernization Act of 1997 (FDAMA), Congress understood that requiring a Premarket Approval (PMA) process for all low- and moderate-risk devices would require significant investment of time and energy on the part of FDA and industry; and so the de novo process was implemented to allow manufacturers an alternative route to clear their device for market without having to go through the rigor of a PMA. Devices cleared through the de novo process will be classified into Class I or II based on the level of risk and the type of controls needed to assure safety and effectiveness (i.e., general controls or special controls as defined by FDA). It is also important to note that these devices can then be used as predicates for other similar types of devices undergoing the 510(k) process.
Originally, to utilize the de novo pathway, the manufacturer was required to submit a premarket notification (510(k)) and the device had to be found “not substantially equivalent” (NSE) to predicate devices currently on the market. This somewhat bureaucratic process was actually a creative way to clear relevant devices for market introduction while staying true to the letter of the device regulation structure. The process was later modified as part of the FDA Safety and Innovation Act of 2012 (FDASIA) to create an alternative “direct de novo” pathway that allows manufacturers to submit a de novo application without the initial step of submitting a 510(k) that must be determined NSE.
The de novo application needs to include information about the device (i.e., the device description, any supportive testing, as well as the labeling), the device’s intended use, the risks and benefits in the population in which it is used, and the rationale for its recommended classification. FDA will then make a classification determination by written order within 120 days of the request. If the device meets the criteria for reclassification, de novo will be granted. The device will then be reclassified and may be marketed immediately. If the de novo is declined, the device will remain in Class III and will require further review through a new de novo or PMA.
Figure. FDA Evaluation of Automatic Class III Designation (de novo) Pathway
NSE, not substantially equivalent; PMA, premarket approval.
Devices that have undergone 510(k) review and were determined NSE due to lack of performance data would be ineligible for the de novo process. FDA suggests using a Pre-Submission (Pre-Sub) process to obtain feedback from FDA on whether a device is eligible for the de novoprocess and what information would be needed. This type of meeting is also useful in facilitating FDA review of a subsequent de novo submission.
To determine if the de novo pathway is right for your device, it is important to perform a thorough search for potential predicate devices, identify risks and benefits, and collect data to provide reasonable assurances of the safety and effectiveness of the device. Sometimes a manufacturer may have the ability to influence the pathway of a device (510(k), de novo 510(k), or PMA) based on the choice of intended use and specific labeling. For example, deviating from a commercialized intended use might require a de novo instead of a 510(k). Similarly, use of labeling claims about new benefits might push a device that could otherwise be classified as a de novo into a PMA. Going the PMA route can create a higher bar to market entry, enhancing a competitive advantage. Consideration of the overall strategy for the device, both the regulatory and marketing aspects, is essential for determining the best path forward.
For further information about the de novo process, you can refer to the draft guidance De Novo Classification Process (Evaluation of Automatic Class III Designation), which was published for comments on August 14, 2014. When final, it will supersede the New Section 513(f)(2) – Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff from 1998.
Experts at NAMSA can assist you in the process by evaluating the strategic submission options, determining the appropriate regulatory pathway, identifying potential predicate devices, creating and submitting the appropriate technical documents for submission, and/or guiding FDA discussions.
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US Food and Drug Administration. De Novo Classification Process (Evaluation of Automatic Class III Designation): Draft Guidance for Industry and Food and Drug Administration Staff. August 14, 2014.http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM273903.pdf.
US Food and Drug Administration. New Section 513(f)(2) – Evaluation of Automatic Class III Designation,Guidance for Industry and CDRH Staff. February 19, 1998.http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080197.pdf.