By Rebecca Mayo, J.D.
The FDA has issued a new proposed rule to establish procedures and criteria related to requests for De Novo classification (De Novo request). The FDA hopes that with codified minimum content requirements, industry will be better able to anticipate what is necessary for successful De Novo classifications and FDA staff will have clearer standards for the content and process for De Novo classification (Notice, 83 FR 63127, December 7, 2018).
De Novo Request. The proposed rule would establish the types of information that must be included in each De Novo request, including things like a table of contents, contact information of the requester, and the establishment registration number of the owner or operator of the request. The request should also include a statement regarding the regulatory history of the device, including prior submissions to the FDA. The device’s indication for use, including a description of the disease or condition the device would diagnose, treat, prevent, cure or mitigate, or how the device would affect the structure or function of the body. A device description should include a description of each of the functional components or ingredients, the properties of the device relevant to diagnosing, treating, preventing, curing, or mitigating the disease or condition and/or the effect of the device on the structure or function of the body, and the operational principles of the device.
The request should also include a description of known or reasonably known existing alternative practices or procedures for diagnosing, treating, preventing, curing, or mitigating the disease or condition for which the device is intended, or which similarly affect the structure or function of the body. The requester should recommend class I or class II classification and explain why the requester believes general controls or general and special controls are adequate to provide reasonable assurance of safety and effectiveness. The request should include a summary of known or reasonably known risks to health associated with the use of the device and any proposed mitigation’s for each probable risk. Published standards relevant to the safety or effectiveness of the device and that are known or should reasonably be known to the requestor should be included along with information to demonstrate how the device meets those standards or a justification for any deviation from those standards.
Granting or declining De Novo request. A requester that fails to provide a complete response to a request for additional information or to any deficiencies identified by the FDA within 180 days of the notification will be deemed to have withdrawn the request and the requester would be required to submit a new request and start the process over again. If the FDA decides to grant a request, it will be granted by administrative order. If the FDA decides to decline a request, it will issue a written order to the requester and the device would remain in class II and may not be legally marketed unless and until it has been approved in premarket approval, cleared in a 510(k), or a new De Novo request has been granted.
The FDA may decline a request if it does not meet the certain criteria under the classification requirements, or the product does not meet the definition of a device under the FDC Act, or if the proposed labeling does not meet regulatory requirements. A request may be denied if it contains a false statement of material fact, or there is a material omission, or if an inspection of a relevant facility determines that the general or general and special controls would not provide a reasonable assurance of safety and effectiveness. If the device is of a type which has already been approved in existing applications for premarket approval or has already been classified into class I, class II, or class III, it will be denied. The request may also be denied if clinical or nonclinical laboratory studies were not conducted in compliance with regulatory requirements, not completed according to study protocol, or there were deficiencies about the study that were not adequately addressed. Finally, a request may be denied if the requester makes significant changes not solicited by the FDA to either the device’s indications for use or to the device’s technological characteristics.
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