Non-Filing Justification
Russian translation: согласование без подачи документации
| 19:30 Apr 27, 2020 |
| English to Russian translations [PRO] Law/Patents - Computers: Software / Regulatory Assessment | |||||||
|---|---|---|---|---|---|---|---|
|
| ||||||
|  Selected response from: mk_lab Ukraine Local time: 18:56 | ||||||
Grading comment
| |||||||
| Summary of answers provided | ||||
|---|---|---|---|---|
| 3 | согласование без подачи документации |
|
| Summary of reference entries provided | |||
|---|---|---|---|
| non-filling justification |
|
Answers
16 hrs confidence: 
| non-filing justification согласование без подачи документации Explanation: Т.е., если компания укажет причины, по которым она не может подать требуемую документацию, ее заявка может быть рассмотрена и согласована без подачи всей документации |
| |
Grading comment
| ||
| Login to enter a peer comment (or grade) | ||
Reference comments
18 mins |
| Reference: non-filling justification Reference information: The non-filing justification is a set of documentation that would confirm that the manufacturer has considered all of the various possible reasons why a new 510(k) submission is not required, and it has determined—after good process—that this truly is the case. https://www.cassling.com/blog/21st-century-cures-act-and-its-impact-on-how-imaging-products-go-to-market |
| |
| Login to enter a peer comment (or grade) | ||
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.
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:
Search millions of term translations