Declarations of conformity and summary reports

E

eliza2008

#1
Hello everyone,
I am preparing my tradditional 510(k), until the 9th part for 510(k),I find the declarations of conformity requirement.and in the guidance document,it says the declarations of conformity is for abbreviated 510(k)s. So I want to know if I should submit declarations of conformity for my traditional 510(k)?
If I have to submit declarations of conformity for my tradditional 510(k) for our ESU, a IIb class product, who could provide me a template of declarations of conformity?
Waiting for good news. Anyone who can give suggestion is appreciated.
:thanks:
 
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Marcelo

Inactive Registered Visitor
#2
Hello Eliza

Right now it´s almost weekend, and the experts generally take some rest from their busy workdays...so you might have to wait a little more for some comments...but i´m surely they will come :)
 
Y

yana prus

#3
Hello Eliza,

If I have to submit declarations of conformity for my tradditional 510(k) for our ESU, a IIb class product, who could provide me a template of declarations of conformity?
Looks like the following links might be helpful.
510(k) Forms
Required Elements for a Declaration of Conformity to a Recognized Standard

The link to form no. 3564 is here:

http :// www .fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM081667.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS
Please note that a separate report is required for each standard referenced in 510(k).

Hope that helps,

Yana
 
Last edited by a moderator:
E

eliza2008

#4
Please note that a separate report is required for each standard referenced in 510(k).

Hope that helps,

Yana
Thank you,Yana.The links are helpful.You said a seperate report is required for each standard. So should I prepare a summary report for standard referenced?and the summary report should include the elements displayed on the website,so what is the format of the summary report?Can you kindly give me a template of this summary report?
Thank you very much.:thanx:
 
Y

yana prus

#5
Dear Eliza,

Can you kindly give me a template of this summary report?
Summary report is the page 2 of form 3564.

http :// www. fda.gov/downloads/AboutFD.../UCM081667.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS

Good Luck,

Yana
 
Last edited by a moderator:
#6
Hi,

I'm setting a traditional 510K, I checked the RTAs but I'm not quite sure if I need the Declarations of conformity and summary reports part. Please help!

Kind regards,

Lilla
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#7
'm setting a traditional 510K, I checked the RTAs but I'm not quite sure if I need the Declarations of conformity and summary reports part. Please help!
From 2018 - Thanks in advance for any help.
 
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