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|English to Portuguese translations [PRO]|
|English term or phrase: 510(K) clearance|
|1.1.2 Provide data to MBC with the purpose of submitting to the United States FDA in order to obtain 510(K) clearance for the treatment of facial rhytides|
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liberação classe 510(K)
What is Premarket Notification [510(k)]
Each person who wants to market Class I, II and some III devices intended for human use in the U.S. must submit a 510(k) to FDA at least 90 days before marketing unless the device is exempt from 510(k) requirements. There is no 510(k) form but instead a format for the submission described in 21 CFR 807 and in the pages that follow.
A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval(PMA). Applicants must compare their 510(k) device to one or more similar devices currently on the U.S. market and make and support their substantial equivalency claims. A legally marketed device is a device that was legally marketed prior to May 28, 1976 (preamendments device), or a device which has been reclassified from Class III to Class II or I, a device which has been found to be substantially equivalent to such a device through the 510(k) process, or one established through Evaluation of Automatic Class III Definition. The legally marketed device(s) to which equivalence is drawn is known as the "predicate" device(s).
Applicants must submit descriptive data and, when necessary, performance data to establish that their device is SE to a predicate device. Again, the data in a 510(k) is to show comparability, that is, substantial equivalency (SE) of a new device to a predicate device.
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aprovação, pelo FDA, do inciso 510(k) sobre notificação...
... de comercialização de (nome do produto).
O 510(k) é uma subdivisão da lei de Alimentos, Medicamentos e Cosméticos [Food, Drug and Cosmetics Act] do FDA.
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