Testing data for Special 510k and contact person

J

Jennifer27

#1
Hi Experts!

My company is planning to submit a special 510k and I was wondering if we should not submit any test reports or data in the submission?

Someone in a recent conference mentioned that they received a "Refuse to Accept" for their Special 510k since they submitted some test reports in the submission.

Also one of our suppliers is in country A (outside US) and they do not want our company (which is in US) either to own their 510k or to act as the contact person on 510k. We are fine with not owning the 510k but a bit concerned that if the supplier in country A becomes the contact person on 510k, wouldn't there be an issue in corresponding with the FDA. Can a company outside US act as an official correspondent on 510k application?Kindly suggest.

Thanks a lot!

I look forward to your advise :)
 
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A

ascherp

#3
As regards the issue of submitting testing documentation with a Special 510(k), the answer depends on the type of testing you intend to submit.

In a nutshell, if you tested your original device to demonstrate conformance with a special control or recognized standard, and you are testing your modified device to validate continued conformance with the same control or standard despite the modification, then a summary of this information may be included in your special 510(k).

However, any other type of testing, e.g., new types of performance data, will result in a conversion to a traditional 510(k) and then the traditional 510(k) RTA checklist will be applied, for which the criteria are different. Chances are high, in this case, that you will receive a refuse to accept letter or rejection.
 
A

ascherp

#4
Hello again,

The submission correspondent can be located anywhere in the world. We're in the Netherlands, for instance, and it's fine. Even when teleconferences are necessary with FDA, they try to accommodate the differences in time zones so that all stakeholders can participate.
 
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