J
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
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