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United States Medical Device Regulatory Framework
Published in Jack Wong, Raymond K. Y. Tong, Handbook of Medical Device Regulatory Affairs in Asia, 2018
The FDA goal to make a final decision for a De Novo classification is 120 days. If a De Novo request is granted,the new device is legally marketed and must be in compliance with applicable regulatory controls;the new device establishes a new classification regulation (as a Class I or II device);the new device may now serve as a predicate device for 510(k) submissions of future devices;FDA publishes in the Federal Register an order that announces the new classification regulation and, for class II devices, the new special controls;FDA posts on its website a copy of the Order notifying the sponsor that we have granted marketing authorization;FDA generates and publically discloses a transparency summary.
Translating Sensor Technology into the Medical Device Environment
Published in Kevin Yallup, Krzysztof Iniewski, Technologies for Smart Sensors and Sensor Fusion, 2017
Frequently, a medical sensor would be expected to fall into the 510(k) category, but what about a sensor type that truly is novel as applied to medical science? What about a sensor device that has the attributes of a Class II device, is NSR, and yet has no direct predicate in the market? With only two pathways available, 510(k) and PMA, such a device would have to be regulated through the PMA route and be Class III, even though it may be extremely safe and effective. In an effort to resolve this logical impasse, the De Novo pathway was initiated by the FDA. A De Novo device is one that is viewed to be low risk and yet does not have an indication for use that matches currently marketed products. Effectively, the device becomes its own predicate…de novo. The process of obtaining De Novo approval is comparable to that for a 510(k) device, but the FDA may invoke an advisory panel review, which adds time to the process.
Regulatory Environment
Published in Gennadi Saiko, Bringing a Medical Device to the Market A Scientist's Perspective, 2022
Initially, De Novo was designed as an option for devices that received a “not substantially equivalent” (NSE) determination in response to a Premarket Notification [510(k)] submission. In 2012 the legislation was amended to allow an applicant to submit a De Novo classification request to the FDA without submitting a 510(k).
Toward standardized premarket evaluation of computer aided diagnosis/detection products: insights from FDA-approved products
Published in Expert Review of Medical Devices, 2020
Lu Wang, Hao Wang, Chen Xia, Yao Wang, Qiaohong Tang, Jiage Li, Xiao-Hua Zhou
Three approval pathways were considered for the CADe and CADx products, including 510(k) notification, premarket approval (PMA) and de novo submission. 510(k) notification is to demonstrate that a new device is at least as safe and effective (substantially equivalent) as a legally marketed device (predicate device) that is not subject to PMA [22]. A comparison of the device to one or more predicates is required to support substantial equivalence claims. PMA application is to give evidence providing reasonable assurance that the device is safe and effective for its intended use, and typically requires clinical studies [23]. Compared to 510(k), PMA is more in-depth and with higher standard as it is the most stringent type of device marketing application required by FDA. The de novo pathway is for novel devices with low or moderate risk which do not have a legally marketed predicate device [24]. Once the de novo is granted, the device is eligible to be used as a predicate for future 510(k) submissions.