501(k) pending at FDA
Polish translation: (urządzenie) w trakcie procedury uzyskania dopuszczenia do obrotu (zgodnie z) 510(k) FDA
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| 08:02 Jul 7, 2014 |
| English to Polish translations [PRO] Medical - Medical: Instruments | |||||||
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|  Selected response from: mike23 Poland Local time: 17:22 | ||||||
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| Discussion entries: 10 | |
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Answers
1 hr confidence: 
| 501(k) pending at fda Aprobata przez The US Food and Drug Administration jest w toku. Explanation: jak wyżej Reference: http://www.fda.gov/ |
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1 day 11 hrs confidence: 
| 501(k) pending at fda (urządzenie) w trakcie procedury uzyskania dopuszczenia do obrotu (zgodnie z) 510(k) FDA Explanation: (urządzenie) w trakcie procedury uzyskania dopuszczenia do obrotu (zgodnie z) 510(k) FDA --- FDA Approval Process for Medical Devices The 510(k) process applies to most Class II medical devices sold in the US and a small number of Class I and Class III devices as well. Technically, the FDA does not "approve" medical devices; they "clear" them for sale. Once a FDA 510(k) number has been granted, it does not expire. However, you must remain in compliance with all FDA regulations to continue selling your product in the US. The FDA may visit your facility at any time to conduct an inspection to ensure you are in compliance with the Quality Systems Regulation (QSR), 21 CFR Part 820. If you are not sure whether your product requires a 510(k), see our easy to understand 7-step guide. We will lead you through the process. http://www.fda510k.com/approval-process http://www.fda.gov/medicaldevices/deviceregulationandguidanc... -------------------------------------------------- Note added at 1 day12 hrs (2014-07-08 20:03:29 GMT) -------------------------------------------------- https://www.google.pl/?gfe_rd=cr&ei=Zk68U8HCBIyH8QeGyoDACw&g... https://www.google.pl/?gfe_rd=cr&ei=eU68U932A4yH8QeGyoDACw&g... -------------------------------------------------- Note added at 1 day12 hrs (2014-07-08 20:05:09 GMT) -------------------------------------------------- Once you have submitted your 510(k), the FDA has 90 days to review it. Please note that review does not mean clearance. During the review process, they likely will ask you for additional information at which time the "clock" is stopped and then resumed upon the FDA's receipt of your answer to their questions. If your product is cleared, the FDA will mail you a letter, with an assigned 510(k) number, that says they "have determined that your device is substantially equivalent to legally marketed predicate devices – and you may therefore begin to market your device subject to the general controls provisions of the Food, Drug and Cosmetics Act." Essentially, when the FDA sends you this letter, they are not "approving" your device, they are saying that your device is substantially equivalent to the predicate device(s) selected in your 510(k), and which has already been cleared for sale by the FDA, and that you are now cleared to sell your device. You will not receive a certificate from the FDA, but this letter will be available on the FDA database as proof to your customers that your product is cleared for sale in the US. Once you have received your FDA 510(k) "clearance" letter, the final step is to complete the FDA device listing and establishment registration using the online FURLS system on the FDA website. |
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Grading comment
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1 day 5 hrs confidence: peer agreement (net): +1
peer agreement (net): +1| 501(k) pending at fda Wyrób został zgłoszony w amerykańskiej agencji FDA (zgodnie z ustępem 510(k) ustawy tej agencji) Explanation: Proponuję w ten sposób. Posiłkuję się tutaj podpowiedzią Jacka i następującymi materiałami: http://www.fda.gov/medicaldevices/productsandmedicalprocedur... http://www.urpl.gov.pl/wm-zgloszenie-do-rejestru-wyrobow-med... Na tej ostatniej stronie rozróżniona jest procedura „powiadomienia” i „zgłoszenia”. Zgłoszenie ma miejsce przed wprowadzeniem wyrobu do obrotu, a powiadomienie już po. Definicja zgłoszenia jest bliższa opisowi procesu 510(k) http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc... Ważna jest również następująca sekcja w opisie zgłoszenia 510(k): „A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA”. 510(k) jest częścią ustawy Food, Drug and Cosmetic Act. Wstawiam poziom pewności niski i dotyczy on tej części w nawiasie -------------------------------------------------- Note added at 1 dzień 15 godz. (2014-07-08 23:20:32 GMT) -------------------------------------------------- Ten opis wyjaśnia, dlaczego 510(k) nie jest procesem uzyskania dopuszczenia do obrotu: „Also known as premarket notification, section 510(k) of the Federal Food, Drug, and Cosmetic Act requires manufacturers of medical devices to notify the Food and Drug Administration (FDA) of their intent to market a medical device at least 90 days in advance. This window of time allows FDA to evaluate whether the device is "substantially equivalent" to a product already on the market, in which case the device does not need to go through the pre-market approval process”. (źródło: http://www.iom.edu/Activities/PublicHealth/510KProcess.aspx) 510(k) to zgłoszenie dotyczące zamiaru wprowadzenia urządzenia do obrotu, z informacją o tym, że spełnia ono konkretne wymagania. Rozpatrując to zgłoszenie agencja może uznać, że urządzenie nie wymaga właśnie dopuszczenia do obrotu. Jeszcze trochę po polsku na temat PMA (pre-market approval) i premarket notification (510(k)) (http://tinyurl.com/ormrlwp) |
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2 days 3 hrs confidence:
| 501(k) pending at fda Złożono wniosek do FDA zgodnie z procedurą 510(k) Explanation: Złożono wniosek do FDA zgodnie z procedurą 510(k) -------------------------------------------------- Note added at 6 days (2014-07-13 13:08:56 GMT) -------------------------------------------------- Wniosek 510(k) oczekuje w FDA Wniosek 510(k) oczekuje na decyzję FDA Wniosek zgodnie z procedurą 510(k) oczekuje w FDA |
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