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Traditional 510(k) Declaration of Conformity

#1
Hello folks, i'm actually building a 510(k) file, i have a question concerning the Declaration of conformity.
Should my DOC contains all the applicable standards for example "ISO 14971 - ISO 13485 - ISO 10993-1 - IEC 60601 - IEC 62304 - IEC 62366-2 ... " it's a huge list should i list all of them with their FDA recognized number?
whay sould i do exactly in this section?
any help will be appreciated .

Thank you
 
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indubioush

Quite Involved in Discussions
#2
Yes. List all consensus standards to which your device conforms along with the number. Note that not every standard is a consensus standard, and a consensus standard may be a previous revision. FDA has a guidance doc called "Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices."
 

Emma2010

Starting to get Involved
#4
Hello folks, i'm actually building a 510(k) file, i have a question concerning the Declaration of conformity.
Should my DOC contains all the applicable standards for example "ISO 14971 - ISO 13485 - ISO 10993-1 - IEC 60601 - IEC 62304 - IEC 62366-2 ... " it's a huge list should i list all of them with their FDA recognized number?
whay sould i do exactly in this section?
any help will be appreciated .

Thank you
And here comes the download link.
https://www.fda.gov/media/71983/download
 
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