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US Regulatory Pathways for Digital Therapeutics
Published in Oleksandr Sverdlov, Joris van Dam, Digital Therapeutics, 2023
Michelle Rubin-Onur, Allison C. Komiyama
When FDA marketing authorization is required (e.g., when the product is not considered a Class I device), medical device manufacturers generally prefer to have their products follow a 510(k) pathway28 due to its inexpensive and relatively quick process. The 510(k) pathway requires a determination that a new device, known as the “subject device,” is Substantially Equivalent (SE) to a legally marketed device. The legally marketed device is referred to as a “predicate device.” Substantial equivalence must be demonstrated in terms of both the devices' intended use and similarities in technological characteristics. Once a device is deemed SE, the device is said to be “cleared” or to have “510(k) clearance” and may be marketed in the US. FDA stipulates that Class I, Class II, and some Class III products for which FDA has not required PMA applications (i.e., those that were marketed before the 1976 Medical Device Amendments to the Act) may be used as predicate devices.
Regulatory Considerations When Deploying your Software in a Clinical Environment
Published in Johan Helmenkamp, Robert Bujila, Gavin Poludniowski, Diagnostic Radiology Physics with MATLAB®, 2020
Philip S. Cosgriff, Johan Åtting
The majority of software defined as SaMD will be classified as either a Class I or Class II medical device, so will not need to go through the full PMA procedure. Most applications for FDA approval will be via the less onerous 510(k) pre-market notification route, but identifying a suitable predicate device may not be straightforward in all cases. Fortunately, the “substantial equivalence” sought relates mainly to the intended use (overall purpose of the device) and indications for use (particular conditions, clinical applications and environment in which device is to be used) rather than a side-by-side comparison of the respective device specifications.
Biomaterials
Published in Manoj Ramachandran, Tom Nunn, Basic Orthopaedic Sciences, 2018
Subhamoy Chatterjee, John Stammers, Gordon Blunn
European conformity (CE) marking and/or USA Food and Drug Administration (FDA) approval provide regulation of the end product prior to being launched on the market. Orthopaedic implants are FDA class III devices requiring extensive pre-market approval. However, if the manufacturer can demonstrate ‘substantial equivalence’ of all or pieces of the device to previously cleared devices, approval can be given without specifically demonstrating safety or effectiveness with clinical studies. For example, different surface coatings, bearing surface and head size could be equivalent to a previously approved device; however the combination may be untested. Novel devices require a full clinical trial for approval for use in patients.
The lateral arm device for mammographic breast procedures: overview of its uses, safety, and efficacy
Published in Expert Review of Medical Devices, 2021
Amy Kerger, Brandy Griffith, Mitva Patel, Jeffrey Hawley, Stephen P. Povoski
For the lateral arm device, there is no data from pre-market pre- or post-FDA studies, as the device only required a 510 (K) premarket notification of intent to market the device. The previous FDA clearance for the upright and supine stereotactic biopsy devices was utilized as the equivalent device to obtain this 510 clearance. The lateral arm is an addition to these already approved biopsy devices and adds no new risk or potential complications to the patient.A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims. A legally marketed device is a device that was legally marketed prior to 28 May 1976 (pre-amendments device), or a device which has been reclassified from Class III to Class II or I, a device which has been found substantially equivalent through the 510(k) process, or a device that was granted marketing authorization via the De Novo classification process under section 513(f)(2) of the FD&C Act that is not exempt from premarket notification requirements. The legally marketed device(s) to which equivalence is drawn is commonly known as the ‘predicate.’ [12]
The Efficacy of Cognitive Videogame Training for ADHD and What FDA Clearance Means for Clinicians
Published in Evidence-Based Practice in Child and Adolescent Mental Health, 2021
Steven W. Evans, Theodore P. Beauchaine, Andrea Chronis-Tuscano, Stephen P. Becker, Anil Chacko, Richard Gallagher, Cynthia M. Hartung, Michael J. Kofler, Brandon K. Schultz, Leanne Tamm, Eric A. Youngstrom
The class to which a device is assigned determines the type of premarketing application required for FDA clearance. Class I and II devices generally require a 510(k) for marketing. This is a premarketing submission made to the FDA demonstrating that the device is safe and effective. Effectiveness is documented by proving substantial equivalence to a legally marketed device (predicate device). When no predicate device exists, the De Novo regulatory pathway for low- to moderate-risk devices of a new type can be used, as was the case for EndeavorRXTM. A De Novo application needs to document (1) probable benefits of the device compared to probable or anticipated risks when the device is used as intended; (2) controls to ensure reasonable assurance of safety and effectiveness; and (3) any clinical and/or nonclinical data that are relevant to ensure reasonable assurance of safety and effectiveness. Because devices in the De Novo pathway are low- to moderate-risk, they “may not need to confer as substantial a benefit to patients in order to have a favorable benefit-risk profile” (FDA, 2019, italics added). An FDA-cleared device from the De Novo pathway can then become a predicate device to which future devices are compared in the 510(k) premarket notification process. Thus, another CT product can now seek FDA clearance based on EndeavorRXTM already being cleared.
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.