Conformance Standards that the FDA recognizes for 510(k)

tebusse

Involved In Discussions
#1
Greetings,

I understand that the FDA recognizes certain conformance standards, which may be included as part of a 510(k) submission. However, what if a company conforms to a standard that the FDA doesn't recognize, such as ISO 13485?

I've noticed that on the "Standards Data Report for 510(k)s" the FDA asks: "Is this standard recognized by FDA?"

Is a company required to delcare a non-recognized standard and prepare a report?

Regards, Tonia
 
Elsmar Forum Sponsor
#2
Re: Conformance Standards 510(k)

Yes, you can list all the standards you comply with on your forms and declaration in sections 2, 9 & 21
 

tebusse

Involved In Discussions
#3
Re: Conformance Standards 510(k)

Thank you.

I believe we would have to prepare a conformance statement, but how would we demonstrate conformance? This cannot be completed with testing, but only with a certificate, yes?
 
#4
Re: Conformance Standards 510(k)

No, they don't have to be certified.

Your QMS, applicable directives, safety, EMC & Harmonics will be certified if required.

The others, such as 14971, will be declared as you will have all the supporting documentation to show that you comply with those.
 
A

ascherp

#5
For a 510(k) submission, you are not required to list all the standards you conform with, but only those directly related to the specific device, such as any standards related to device testing (bench or other), sterilization, cleaning, etc. Within this group of standards, you can include those recognized by the FDA and others that the FDA may not recognize, but that support your endeavor of demonstrating the safety and effectiveness of your device (and its substantial equivalence).

Other general standards are not usually required. ISO 14971, for instance, would only be absolutely necessary for a Special 510(k). ISO 13485 is not an issue at all.

An FDA reviewer-turned-friend (also author of guidance documents) always advises: "Include what is necessary, no more. That reduces the burden on us--and on you, because if you include it, we must look at it, and it may result in additional questions."
 
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