FDA Approved Product Contact Parts

prephil

Involved In Discussions
#1
I work in a machine building company in the EU. I often hear mentioned that a product contact material needs to be approved by the FDA to ensure we can use it.
Does a list of FDA approved plastics/polymers and metals exist. If so, where can I find it?
 
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shimonv

Trusted Information Resource
#2
The FDA does not approve raw materials but rather finished medical devices and their accessories.
The evaluation is done at the device/accessory level based on biocompatibility test reports or biological evaluation reports. There is not list of approved raw material to be used in a medical device.
 

prephil

Involved In Discussions
#3
Yes, but is there a list of material that is allowed to come in contact with medical devices are is that at the discretion of the med device manufacturer?
typically, I see 316 stainless mentioned as a type of material that is satisfactory.
I am involved in the building of the machine that assembles the med device so coming at it from this angle (as opposed to the direct manufacturer of the device itself).
 
#4
There is a recent DRAFT document here:

Biocompatibility Select Updates for Intact Skin

From there you can download the document.
It applies only to intact skin contact, for less than 24hrs and from the list of polymers and fabrics given in the guidance.
I believe it is an update to an existing guidance.

The Draft seems to be saying that the FDA consider it is taking them too much time to review yet more 10993 data for materials that are well known and very low risk. It also goes with the desired outcome of a reduction in animal testing.

The big proviso of this is it is a DRAFT document only. So, you can use it to understand FDA thinking but not to support a regulatory submission.
 

prephil

Involved In Discussions
#5
Thanks Pads, there's no mention of metals in the document, just polymers. Would you know of something that mentions metals? Actually it says the
following. Does that mean stainless is acceptable for product contact. Surely it does.

Stainless.jpg
 

planB

Trusted Information Resource
#6
prephil,

in line with shimnov's response, there is no limitation to manufacturing-equipment materials other than these materials shall not adversely affect the biocompatbility of the final medical device.

@prephil: the mentioned FDA draft guidance pertains exclusively to materials of intact-skin contacting devices (not manufacturing equipment), irrespective of contact duration - have a look at lines 106 and 107 in this draft.

HTH,

Gerhard
 
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