In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of current and former FDA reviewers, scientists, engineers and regulatory and quality experts, and adds additional expertise with FDA submissions. The author of this post is a member of this team, which has done significant work with novel and/or high-risk devices focusing on pre-submissions, 510(k)s, IDEs, PMAs, De Novos, Breakthrough Designation Requests and Safer Technology Program Requests.
Briefly, the de novo pathway (as mentioned in our previous blog post) is an alternate pathway added through the Food and Drug Administration Modernization Act of 1997 (FDAMA). This pathway was added in order to classify novel, low- to moderate-risk Class I and Class II medical devices that did not have an acceptable predicate device (in order to establish substantial equivalence via the 510(k) pathway), and had not already been classified as Class III (“high-risk” devices).
There are still two routes for a de novo classification:
1. Submitting a de novo request to the FDA after an NSE determination in response to a 510(k) submission.
2. If there is no legally marketed device upon which to base a determination of substantial equivalence, the sponsor may submit a de novo request without first submitting a 510(k) and receiving an NSE determination.
Such devices cleared through the de novo pathway may be used as predicates for future 510(k) submissions. Though not required, FDA strongly recommends a Pre-Submission in order to obtain early feedback from FDA, saving the submitting company both time and money. A Pre-Submission will not only help sponsors obtain feedback on whether a device may be eligible for the de novo classification process, but also feedback on any on non-clinical and/or clinical data that will likely be necessary to support the de novo request.
In terms of the submittal, the de novo application should be submitted as an e-copy to the appropriate Document Control Center in CDRH or CBER. FDA’s goal is make a decision on the de novo request in 150 days. Since 2010, FDA has been releasing summaries of the devices cleared through the de novo process which will help sponsors that may wish to use the device as a predicate for future 510(k) submissions. Starting on October 1, 2017, changes were made to the user fees that are as follows: FDA now charges a fee for review of the de novo application unless you qualify for one of the exceptions:
1. The device being submitted is a device intended solely for a pediatric population
2. Any application from a state or federal government entity
In 2017, FDA also released guidance documents on the de novo Classification Process and User Fees and Refunds for de novo Classification Requests. De novo may be a faster pathway for you to get your novel, low- to moderate- risk devices to the market. Ask your regulatory consultant if a de novo is right for you!
Additional Reading (Guidance Documents):
1. De Novo Classification Process
2. User Fees and Refunds for De Novo Classification Requests
3. FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals