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What are FDA expectations regarding Standards referenced in the 510(k)?

#1
My company is in a pre-production design phase for a medical device that has already achieved CE Mark and had one successful clinical trial, with a larger one on the horizon.

During the CE Mark audit by a major NB, the auditor insisted that our Technical File and Essential Requirement checklist only reference the latest harmonized version of a standard, whether or not that was the one we actually owned or had used. So we revised the documents using the EN version of many standards in which we actually had or used the IEC or ISO version. I still feel uncomfortable having done that, but it was what the NB wanted, so we went along and were approved.

  • Can anyone tell me what the FDA's expectations or requirements are with regards to the standards referenced in the 510(k) and how they are identified?
  • Is there any requirement that the standards that are referenced must be in stock?
  • Will the FDA ask what we have done to address standards that were revised after we referenced them, with regard to impact on the design of the product or risk?
Thanks for your help.


Scott
 

Ronen E

Problem Solver
Staff member
Super Moderator
#3
My company is in a pre-production design phase for a medical device that has already achieved CE Mark and had one successful clinical trial, with a larger one on the horizon.

During the CE Mark audit by a major NB, the auditor insisted that our Technical File and Essential Requirement checklist only reference the latest harmonized version of a standard, whether or not that was the one we actually owned or had used. So we revised the documents using the EN version of many standards in which we actually had or used the IEC or ISO version. I still feel uncomfortable having done that, but it was what the NB wanted, so we went along and were approved.

  • Can anyone tell me what the FDA's expectations or requirements are with regards to the standards referenced in the 510(k) and how they are identified?
  • Is there any requirement that the standards that are referenced must be in stock?
  • Will the FDA ask what we have done to address standards that were revised after we referenced them, with regard to impact on the design of the product or risk?
Thanks for your help.


Scott
Well...

The interaction you describe with that NB sounds to me at least a bit odd. I can't really understand it, could it have been a miscommunication? The only explanation I can think of (which downgrades the issue from :mg: to just :confused:, but doesn't completely eliminate it) is that the subject standards were such that there was no normative difference between the ISO or IEC versions and the EN ones, and the NB verified that...

To your questions --

  • Can anyone tell me what the FDA's expectations or requirements are with regards to the standards referenced in the 510(k) and how they are identified?

    A: The FDA has a recognized standards database. As long as you refer to one that is currently there, in a proper context (look for the "extent of recognition" & "related processes" sections in the specific recognized standard webpage), there will be no issue with the recognition. Otherwise, FDA will likely ignore the fact that you used the standard.

  • Is there any requirement that the standards that are referenced must be in stock?

    A: Yes, or you must at least be able to show that the version in stock is identical for all relevant clauses (in the latter case FDA might still give you a hard time so I wouldn't recommend it).

  • Will the FDA ask what we have done to address standards that were revised after we referenced them, with regard to impact on the design of the product or risk?

    A: FDA relates to any reference of yours based on the recognition status by the time you submit. If the older version is still recognized, that's fine. If not, it's either you upgrade to the currently recognized scope, or the FDA will pretty much ignore that reference. Once your submission has been finalized, there's no need to keep up with recognition changes, unless otherwise specifically stated by the FDA.

Cheers,
Ronen.
 
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