Listing standards in a traditional 510(k)

Le Chiffre

Quite Involved in Discussions
#1
Are there any considerations when listing standards on a traditional 510(k)? Section I of the cover sheet (Form FDA 3514) says:
Complete this section if your application cites standards or includes a "Declaration of Conformity to a Recognized Standard" statement.
Should all applicable standards, 3rd party tested and self-certified, be included?
What about FCC part 15?
My application also cites ISO 14971, should that be mentioned too?

Thanks
 
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Michael Malis

Quite Involved in Discussions
#2
Are there any considerations when listing standards on a traditional 510(k)? Section I of the cover sheet (Form FDA 3514) says:

Should all applicable standards, 3rd party tested and self-certified, be included?
What about FCC part 15?
My application also cites ISO 14971, should that be mentioned too?

Thanks
Section 1 of form 3514 asks you for “submission standards or …recognized standards”.
This section should only include all major standards and also standards recognized by the FDA.

Specifically, if you use any CLSI standards you should include them because FDA recognized CLSI.
Also, as an example of major, you should include reference to ISO 13485, ISO 14971, ISO 10993 and ISO 15223. Those are Quality System standards (13485) and specific standards (Biological evaluation for medical devices – ISO 10993; Application of Risk management - ISO14971; Symbols to be used with medical labels – ISO 15223).

In reference to the last example above, I would not include ISO 980 (General symbols labeling standard) because it is not recognized by the FDA and any other referenced self-certified standards.

Please keep in mind, that when you state compliance, make sure it is for the right revision of this standard – good example here would be ISO 14971 (You most likely comply to 2000 revision and not 2007…)

Hope this helps,
Mike
 

Le Chiffre

Quite Involved in Discussions
#3
Thanks for the response, Mike.
That's just the information I was looking for.

Just to clarify (for anyone else hunting for this info). You mean:
This section should only include major standards that are recognized by the FDA.
i.e. Include applicable major standards that appear in the FDA's recognized list.
 
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R

regfocus

#5
.....
Specifically, if you use any CLSI standards you should include them because FDA recognized CLSI.
Also, as an example of major, you should include reference to ISO 13485, ISO 14971, ISO 10993 and ISO 15223. Those are Quality System standards (13485) and specific standards (Biological evaluation for medical devices – ISO 10993; Application of Risk management - ISO14971; Symbols to be used with medical labels – ISO 15223).
.....
Mike
Hi Mike,

Thanks for your explanation. I agree most of you mentioned except your comments on quality system. I do not recommend to add compliance with quality system into this section. ISO 13485 is not 510k required and will not be helpful for the application.
 
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R

regfocus

#8
Coincidentally, the xxxxxxxx doesn't contain ISO 13485, however it does have 14971.
I also do not recommend you to add ISO 14971:2007 into your submission. If you declare that you comply with it, then you have to explain which clause you comply with. If time and labor is enough, yes, you can do it. Otherwise, it is not necessary to include it into submission.

Think about from another direction. ISO 14971 is applicable to any medical device, does that mean every submission declares comply with that?
 
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M

MIREGMGR

#9
I also do not recommend you to add ISO 14971:2007 into your submission. If you declare that you comply with it, then you have to explain which clause you comply with. If time and labor is enough, yes, you can do it. Otherwise, it is not necessary to include it into submission.

Think about from another direction. ISO 14971 is applicable to any medical device, does that mean every submission declares comply with that?
14971-2007 is a Recognized Consensus Standard. See http ://www .accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/SimpleSearch.cfm?db=STD&id=19639 - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS

Based on both recent 510(k) preparation-and-filing experience and a significant body of comments by CDRH leadership over the past several years, documentation of risk analysis utilizing 14971 as a guidance is expected in current 510(k) filings of both Traditional and Special format.

This builds on 21 CFR 820.30's explicit requirement that design validation must include risk analysis. In the past, some have interpreted this statement to mean that risk analysis was required only for software. The FDA has explained this point several times; see for instance http ://www fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/HumanFactors/ucm119215.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS, where it is clarified that risk analysis (in this case, in relation to human factors and use engineering) is a freestanding requirement applicable to entire devices, not merely to software.
 
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Michael Malis

Quite Involved in Discussions
#10
...ISO 13485 is not 510k required and will not be helpful for the application.
You are required to list all applicable standards.
If you build Medical Devices than ISO 13485 Standard is applicable for Manufacturer of Medical Devices and some companies in addition, still have ISO 9001!

I asssumed that you don't build product in the basement...
 
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