![]() has different technological characteristics and does not raise different questions of safety and effectiveness and.has the same technological characteristics as the predicate.has the same intended use as the predicate and.Substantial equivalence means that the new device is as safe and effective as the predicate.Ī device is substantially equivalent if, in comparison to a predicate it: The manufacturer should be prepared for an FDA quality system (21 CFR 820) inspection at any time after 510(k) clearance.Ī 510(k) requires demonstration of substantial equivalence to another legally U.S. The submitter may market the device immediately after 510(k) clearance is granted. Please note that FDA does not typically perform 510(k) pre-clearance facility inspections. The SE determination is usually made within 90 days and is made based on the information submitted by the submitter. Once the device is determined to be SE, it can then be marketed in the U.S. Until the submitter receives an order declaring a device SE, the submitter may not proceed to market the device. ![]() Legally marketed also means that the predicate cannot be one that is in violation of the FD&C Act. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate." Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate. A legally marketed device is a device that was legally marketed prior to (preamendments device), or a device which has been reclassified from Class III to Class II or I, a device which has been found SE 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. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims. This order "clears" the device for commercial distribution (see The 510(k) Program Guidance).Ī 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). Before marketing a device, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S. There is no 510(k) form however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission. 9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9). Please note: FDA charges a fee for review of Premarket Notifications IntroductionĮach person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and does not exceed the limitations of exemptions in.
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