510k submission for class II medical device

L

leroybrown

#1
Our company has compiled a traditional 510k submission for a class II medical device based on the FDA guidance on Format for Traditional and Abbreviated 510(k)s.

A consultant has looked at what we compiled and is telling us that all testing results must be included in the submission. Is this right? We currently indicate the standards we shall comply with as well as the 3rd party testing facilities that are conducting IEC and sterilization validations. Does the FDA require test results. We have 2 predicate devices we are claiming SE to.
 
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M

MIREGMGR

#2
The relevant guidance is here:
A description of the tests and the results obtained are essential. Reasonable and sufficient details of all test procedures and results should be submitted to FDA.
We normally submit a comprehensive description of the test design/method/intent, and the results. We don't submit the entire test report, i.e. the lab's statements of GLP compliance methods, instrumentation calibration procedures, personnel involved and their qualifications, etc., etc. We then include a statement that the full report is available at our location for inspection, and we add it to our regulatory archives.
 
L

leroybrown

#3
Thanks!

It has been a few years since our company has had the need to submit a 510k. Those individuals that were involved in the process are no longer here and our older 510k submission files do not capture current requirements, so your assistance is greatly appreciated.

There's nothing like hands-on learning! :)
 
C

CBAL08

#4
Could anyone help me regarding an issue with 510K (Traditional/Special) submission?
There are few test results we use as a supporting document in the application such as some certificates and test results in other language other than English. Do we have to translate these kind of documents to English?
Is there a requirement somewhere in FDA site whichs ays everythign we submit should be in English?
Please help.
 
M

MIREGMGR

#5
Do we have to translate these kind of documents to English? (...) Is there a requirement somewhere in FDA site whichs ays everythign we submit should be in English?
Yes. This expectation is stated in multiple locations, and not always in the most direct manner, but that is the FDA's requirement. See for instance the last paragraph of this page: U S Food and Drug Administration Home Page - DEAD LINK --> ICECI/Inspections/IOM/ucm122498.htm
 
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B

brandomenon

#6
Could anyone help me regarding an issue with 510K (Traditional/Special) submission?
There are few test results we use as a supporting document in the application such as some certificates and test results in other language other than English. Do we have to translate these kind of documents to English?
Is there a requirement somewhere in FDA site whichs ays everythign we submit should be in English?
Please help.
English is preferred for submission in the US as it is the official language. The reviewer will need to understand all of the information presented; if there is any difficulty due to language issues, it will cause delays. It would be in your best interest to make everything as easy as possible to understand.
 
S

sanjay_lingot

#7
Surely FDA need testing result with testing certificates.

with kind regards

Sanjay Lingot
 
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