FDA Consensus Standards in 510(k) - Declarations of Conformity



Hi, seeing if I can get some insight on the Declarations of Conformity section of our 510(k) application... Thanks in advance if anyone can point me in the right direction.

We have an existing Class II sterile implant that we're working on a new Traditional 510(k) for an MRI compatibility claim-- no physical change to the device was made. We had performed the packaging validation/studies in 2007 and used the packaging standards in effect at the time (e.g. ASTM F88-06 Standard Test Method for Seal Strength of Flexible Barrier Materials), but most standards have since been updated (e.g. to ASTM F88/F88M-09). How should I handle listing that has an FDA Consensus Standard in the 510(k)? Am I allowed to use the 2009 version if what we used was the 2006 version?

Ronen E

Problem Solver
You can only declare conformity to a standard you actually tested to.

A submission should only relate to revisions that are current (per FDA) at the time of submission.


Quite Involved in Discussions

I need some clarity here, I agree the declaration of conformity should state that the actual test revision.

Regarding the submission to FDA, why should I use the revision current to FDA, because my revision results from V & V few years before was from different Rev and If we chose not to submit at that point of time and later chose to submit when the rev changes...will that be acceptable to use the rev level what was current than now in the FDA standards consensus database.

Mark Meer

Trusted Information Resource
If you're planning to submit test-result from a previous revision to an FDA standard consensus standard, then it'd be your task to identify the differences between the revisions and ask yourself: "do these differences affect my test results"?

It may well be the case that the updated standard simply adds a bunch of clauses that have nothing to do with your device.

Or maybe there were some minor updates to acceptance criteria, in which some gap-testing may be appropriate, or you can dig up the test-data you have (if measurements were made), and show that the test results still meet the new acceptance criteria.

In anycase, you will likely be asked why your submission lists a previous revision of a consensus standard, and it will be your task to justify why you think the tests to the previous revision are still valid.
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