510(K) clearance

Portuguese translation: aprovação, pelo FDA, do inciso 510(k) sobre notificação...

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:Provide data to MBC with the purpose of submitting to the United States FDA in order to obtain 510(K) clearance for the
Portuguese translation:aprovação, pelo FDA, do inciso 510(k) sobre notificação...
Entered by: Teresa Cristina Felix de Sousa

16:20 Jan 24, 2003
English to Portuguese translations [PRO]
Medical
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
Teresa Cristina Felix de Sousa
Brazil
Local time: 04:15
aprovação, pelo FDA, do inciso 510(k) sobre notificação...
Explanation:
... 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.
Selected response from:

Lilian Jimenez-Ramsey
United States
Local time: 00:15
Grading comment
Obrigada, colega
4 KudoZ points were awarded for this answer



Summary of answers provided
5aprovação, pelo FDA, do inciso 510(k) sobre notificação...
Lilian Jimenez-Ramsey
5liberação classe 510(K)
Roberto Cavalcanti
3 +1aprovação (do FDA) tipo 510(k)
Elisabeth Ghysels


  

Answers


13 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
aprovação (do FDA) tipo 510(k)


Explanation:
Cumprimentos,

Nikolaus


    Reference: http://www.baumer.com.br/Noticias/2000/Noticias_2011004.htm
    Reference: http://forum.europa.eu.int/irc/enterprise/tcam/info/data/off...
Elisabeth Ghysels
Local time: 09:15
PRO pts in pair: 44

Peer comments on this answer (and responses from the answerer)
agree  Clauwolf
2 hrs
Login to enter a peer comment (or grade)

49 mins   confidence: Answerer confidence 5/5
liberação classe 510(K)


Explanation:
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.



    Reference: http://www.fda.gov/cdrh/devadvice/314.html
Roberto Cavalcanti
Brazil
Local time: 04:15
Native speaker of: Portuguese
PRO pts in pair: 7462
Login to enter a peer comment (or grade)

2 hrs   confidence: Answerer confidence 5/5
aprovação, pelo FDA, do inciso 510(k) sobre notificação...


Explanation:
... 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.

Lilian Jimenez-Ramsey
United States
Local time: 00:15
Native speaker of: Native in PortuguesePortuguese
PRO pts in pair: 65
Grading comment
Obrigada, colega
Login to enter a peer comment (or grade)



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