In 510k application do we submit documents showing compliance with 21CFRPart820

E

ejacob3

#11
THank you, I was asking a loaded question. My new company is in the practice of sending off 510ks before the planning even begins. The process of risk management for example is inherently ingrained into design controls.

I was floored when I was requested to provide a risk management report, 60601 compliance etc. The risk mgmt report alone is an output of activities where we are providing evidence that risk mitigations are effective as well as summarizing testing etc to say the least.
 
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DannyK

Trusted Information Resource
#12
I have a question about 510k.
Company A has received a 510k in 2020. Company B wants to apply for a 510k with the same device but wants their own 510k and through an agreement has access to Company A's 510k and all the associated reports. The product will be the same.
Will EMC and electrical safety tests have to be redone or can they be submitted under Company A's name? Is it possible for Company B to use the reports from Company A's 510k?

Thanks for your help
 

Watchcat

Trusted Information Resource
#13
I will never predict what FDA will or won't accept on any given day of the week, but, IMO, all tests are adequate to support all devices that meet the same specifications as those that were tested. So, yes, I would submit the same reports as those previously submitted by Company A. For document control purposes, I might generate my own one-page "reports" that are effectively cover sheets for each of their reports, with my own company's info, document control numbers, brief summary of test and results, and then include the other report as an attachment to my "report."
 
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