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Jan 9, 2019 14:16
5 yrs ago
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English term
cleared vs approved medical devices
English to Serbian
Medical
Medical (general)
Zdravo :)
Da li možete da mi kažete kako pravimo razliku u srpskom jeziku između cleared i approved? Approved je, pretpostavljam, odobreno.
Definicija termina na engleskom: https://www.fda.gov/medicaldevices/resourcesforyou/consumers...
Hvala unapred.
Da li možete da mi kažete kako pravimo razliku u srpskom jeziku između cleared i approved? Approved je, pretpostavljam, odobreno.
Definicija termina na engleskom: https://www.fda.gov/medicaldevices/resourcesforyou/consumers...
Hvala unapred.
Proposed translations
5 hrs
Sladjana Daniels
Serbia
Serbia
Native in Serbian
Specializes in field
Serbia
Perfect blend of medicine and languages
Native in: Serbian
Works in: English to Serbian, Serbian to English
Related KudoZ points
:
96
potvrđena vs odobrena medicinska sredstva
Predlog...
To provide clearance bi bilo izdati potvrdu.
To provide clearance bi bilo izdati potvrdu.
+1
7 hrs
Gordana Sujdovic
Serbia
Serbia
Native in Serbian
Specializes in field
Serbia
English to Serbian/Croatian/Bosnian&vv
Native in: Serbian
Works in: English to Serbian, Serbian to English, English to Croatian, and 7 more.
Related KudoZ points
:
8
med. sr. s dozvolom za stavljanje u promet prema 510(k) FDA vs odobrenim za uvođenje na tržiše USA
medicinska sredstva s izdatom dozvolom za stavljanje u promet u skladu s 510(k) FDA nasuprot odobrenim za uvođenje na američko tržište
ako se pominje FDA, ne znam kako bih kraće, a da bude jasno
Cleared Vs. Approved
Clearance requests are for medical devices that are exactly like those already on the market. Approved requests are for items that are completely new and need to be inspected for safety in case of new hazards. Both aspects need to be proved or provided by the submitter to ensure proper procedures are followed.
https://pocketsense.com/fda-cleared-vs-fda-approved-12411802...
approved: (PMA process - "pre-market approval" (PMA))
In order for medical devices to be legally marketed (sold) in the United States, they are required to be cleared or approved by the FDA unless it is 510(k) exempt. Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to (similar) another legally marketed device.
Cleared: Class 2 risk
Approved: Class 3 risk
ako se pominje FDA, ne znam kako bih kraće, a da bude jasno
Cleared Vs. Approved
Clearance requests are for medical devices that are exactly like those already on the market. Approved requests are for items that are completely new and need to be inspected for safety in case of new hazards. Both aspects need to be proved or provided by the submitter to ensure proper procedures are followed.
https://pocketsense.com/fda-cleared-vs-fda-approved-12411802...
approved: (PMA process - "pre-market approval" (PMA))
In order for medical devices to be legally marketed (sold) in the United States, they are required to be cleared or approved by the FDA unless it is 510(k) exempt. Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to (similar) another legally marketed device.
Cleared: Class 2 risk
Approved: Class 3 risk
Peer comment(s):
| agree |
Daryo
2 hrs
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Хвала, очигледно се ради о америчком систему, цео описни одговор је наведен у објашњењу. Registered, cleared and approved by FDA, према класама ризика 1, 2 и 3. https://www.proz.com/kudoz/english-to-polish/medical-general...
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| neutral |
gavrilo
: Мислим да је само за превод ту баш превише детаљисања. Ако је потребно, то би требало дати у фусноти или сл, а не тиме оптерећивати основни текст.
2 days 4 mins
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Slažem se, samo kod nas nema ekvivalenta, radi se 3 postupka kod FDA, uključujući Registered.....zato je CL 1
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Reference comments
7 hrs
Reference:
What is the difference between Cleared and Approved?
In order for medical devices to be legally marketed (sold) in the United States, they are required to be cleared or approved by the FDA unless it is 510(k) exempt.
Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to (similar) another legally marketed device. A premarket notification submission is referred to as a 510(k) and must be submitted to FDA to review and provide clearance.
Approved medical devices: Approved medical devices are those devices that the FDA has approved a premarket approval (PMA) application or a Humanitarian Device Exemption (HDE) application. This review and approval process is for Class III medical devices (the ones with the highest risk) and involves a more rigorous review than the 510(k) review process.
https://www.fda.gov/medicaldevices/resourcesforyou/consumers...
Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to (similar) another legally marketed device. A premarket notification submission is referred to as a 510(k) and must be submitted to FDA to review and provide clearance.
Approved medical devices: Approved medical devices are those devices that the FDA has approved a premarket approval (PMA) application or a Humanitarian Device Exemption (HDE) application. This review and approval process is for Class III medical devices (the ones with the highest risk) and involves a more rigorous review than the 510(k) review process.
https://www.fda.gov/medicaldevices/resourcesforyou/consumers...
Peer comments on this reference comment:
| neutral |
gavrilo
: Даре, то је већ све дала колегиница Милица у свом питању, читај мало пажљивије - што свакако није лако за неког тако заробљеног у СВОМ 'RealWorld v1.0' ;-) // I haven't noticed (dead links) ;-) - хвала ти, Даре, што си ми 'отворио очи'!!! :-)
1 hr
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In case you haven't noticed, links sometimes turn to dead links - someone reading this question in few months time may not have much use for a dead link. These questions are supposed to be useful for years to come - links don't always last forever.
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