FDA’s Final Rule for De Novo Classification: Mostly Unchanged Process
(Thursday, October 7, 2021)
This week FDA published the final rule for the De Novo classification request for novel medical devices keeping the process mostly same as the previous rule. The process still requires that the applicant submit a detailed De Novo Class I or II designation request after the 510k application has been rejected or no predicate exists, and that the FDA would decide within 120 days if the classification request is granted or denied. The updates to the rule are mostly administrative in nature to clarify previous processes such as the order of information included in the De Novo request, requirement that the non-clinical and clinical studies used in the request must include both the protocol and the full report of the studies, removing the requirement that the applicant provide fax numbers, or that the applicant refer to a volume number for single volume applications. The De Novo requests are a critical regulatory process for devices that either are deemed by FDA to not be substantially equivalent to previously approved 510k devices, or which are novel devices unlike anything previously cleared or approved by the FDA. These devices mostly involve new technologies, e.g., most software medical devices could contain novel technologies unlike anything previously approved by the FDA, which would automatically get classified as Class III devises needing expensive and time-consuming PMA applications, unless the applicant files a De Novo Class II or Class I designation request. Once FDA classifies a device as a De Novo Class II device, all subsequent similar devices can use the first device as a predicate and do not need to file their own De Novo requests. The Final rule merely formalizes the practices that have already been implemented via the various guidance documents published by the FDA over the last few years. The rule should not change any ongoing or planned De Novo requests.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC