cleared vs approved medical devices

14:16 Jan 9, 2019

This question was closed without grading. Reason: Other

English to Serbian translations [PRO]
Medical - Medical (general)

English term or phrase: cleared vs approved medical devices

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.

Milica Dragićević KudoZ activity Questions: 29 (none open) (4 without valid answers) (4 closed without grading) Answers: 0 Serbia
Local time: 01:48

Summary of answers provided

1 +1

med. sr. s dozvolom za stavljanje u promet prema 510(k) FDA vs odobrenim za uvođenje na tržiše USA

Gordana Sujdovic

potvrđena vs odobrena medicinska sredstva

Sladjana Daniels

Summary of reference entries provided

What is the difference between Cleared and Approved?

Daryo

Answers

5 hrs confidence:

potvrđena vs odobrena medicinska sredstva

Explanation:
Predlog...

To provide clearance bi bilo izdati potvrdu.

Sladjana Daniels
Serbia
Local time: 01:48
Specializes in field
Native speaker of: Serbian
PRO pts in category: 96

7 hrs confidence:

peer agreement (net): +1

med. sr. s dozvolom za stavljanje u promet prema 510(k) FDA vs odobrenim za uvođenje na tržiše USA

Explanation:
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

Gordana Sujdovic
Serbia
Specializes in field
Native speaker of: Serbian
PRO pts in category: 8

Peer comments on this answer (and responses from the answerer)

agree

Daryo

2 hrs

-> 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...

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

-> Slažem se, samo kod nas nema ekvivalenta, radi se 3 postupka kod FDA, uključujući Registered.....zato je CL 1

Reference comments

7 hrs

Reference: What is the difference between Cleared and Approved?

Reference information:
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...

Daryo
United Kingdom
Works in field
Native speaker of:

Serbian,

French
PRO pts in category: 32

Login or register (free and only takes a few minutes) to participate in this question.

You will also have access to many other tools and opportunities designed for those who have language-related jobs (or are passionate about them). Participation is free and the site has a strict confidentiality policy.

Return to KudoZ list

KudoZ™ translation help

The KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.

See also:

ProZ.com term search

Search millions of term translations

cleared vs approved medical devices

Answers

Reference comments

KudoZ™ translation help

Your current localization setting

Select a language

cleared vs approved medical devices

Answers

Reference comments

KudoZ™ translation help

You have native languages that can be verified

Your current localization setting

Select a language