510(k) submission - Questions about page 2 of form 3654

[wangyang]

Hi all
When i am preparing the 510(k) submission, i have to complete the form 3654, in page 2 of this form, it states that all sections should be considered and marked with "yes, no or N/A". When there is a long standard, such as IEC 60601-1, what does it mean by " section" and how many pages do you use?

 

[AndyN]

Re: questions about the page 2 of form 3654

Welcome to the Cove, wangyang!

It is the weekend here in the USA so your question will probably be answered in about 12 - 24 hour time. We hope you get what information you need and come back for more and to share your experiences.

 

[Ajit Basrur]

Any takers ?

 

[MIREGMGR]

When i am preparing the 510(k) submission, i have to complete the form 3654, in page 2 of this form, it states that all sections should be considered and marked with "yes, no or N/A". When there is a long standard, such as IEC 60601-1, what does it mean by "section" and how many pages do you use?

We usually would regard IEC 60601-1 in its entirety as a single "section" for purposes of Form 3654, or at most as fitting onto one Page Two. However, it's possible that our applications of standards don't involve as many deviations as others might have. With 60601-1, for instance, we typically either apply a section in its entirety or don't apply it at all.

If we had a device for which one section of a long standard was applied and many other sections were not applicable, we would group the not-applicable sections into one entry-block on Page Two, and explain their non-applicability in a Summary Report.

If we had a device for which our application of a standard had extensive and complex deviations and justifications, we would attach a separate Summary Report rather than try to fit the information into the Page Two format.

 

[melissa66]

I had that same question...When I filled mine out, I only separated 60601 into portions based on testing: safety and emissions and immunity; basically because I got separate reports for each portion. Also, since there was no deviations in my tests, I didn't think that it was useful to mention every section of the standard. I have not heard anything back yet from the FDA ... to see if I completed it wrong.

 

[celia4237]

Here is the response i received from FDA.

"You could group the sections. For example if sections 12, 13, and 14 are all N/A then you could state it that way. Please let me know if you need anything else."