How to fill out Form 3654 for Material Conformity

NicoleinFlorida

Inactive Registered Visitor
#1
Hello all,

This is my first post and I have a problem with Form 3654.

Currently, I am working on the 510k for our new device and one of its main component is made of Titanium. According to the requirements, because we will rely on the standard ASTM F67 and will not provide any bio-compatibility testing reports, we need to fill out the Form 3654.

Here are my questions:
"Was a third party laboratory responsible for testing conformity of the device to this standard identified
in the 510(k)?" ----- We will not test the conformity. Instead, our supplier make the statement in the purchasing order that the titanium meets with Chemical composition of ASTM F67. So for this question, should I fill in "NO"? Because we cannot provide the lab testing report.Or how could I answer this question?

And if the answer to this question is "NO", in the second page, what kind of information should I fill in the section of "Justification"?

Look forward to your answers. Really appreciated.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hello Nicole and welcome to the Cove :bigwave:

In my opinion unless your supplier confirms in writing that a third party laboratory was responsible for testing conformity of the device to ASTM F67 you should answer No. The justification you should provide consequently is whatever you have from your supplier. I think that's the best you can do without spending more on testing or formally engaging an expert toxicologist.

The above might fly as the evidence / literature for titanium biocompatibility is extensive. However, the FDA might require more. Have a look at the flowchart on p. 34 in this draft guidance. If your predicate has a similar titanium component it might help.

Cheers,
Ronen.
 
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