USP Class I & II - Raw material supplier liability and responsibility

[Martin_v_W]

Dear all,
we are a titanium dioxide pigment manufacturer and currently develop a new pigment for plastics. We already have FDA food contact clearance and I wonder what is needed to open medical device markets in USP class I and II.

Most threads for medical device certification only talk about the manufacturer, not their plastic compound supplier and, even further up the chain, raw material manufacturers like us.

What kind of information do we need to supply to the value chain and what is our liability in providing a raw material into this application? What can we do to help the device manufacturer get his 510k for class II applications?

Thanks & best wishes,
Martin

 

[Marc]

Can any of the FDA people here help with this question?

 

[MIREGMGR]

USP qualification is appropriate for pharmaceutical packaging applications. It is not relevant to the current (~1995) FDA ISO 10993-based regulations regarding medical devices, or to the preceding (~1984, "Tripartite") regulations, either.

Under the current regulations, a compounded-plastic-resin supplier wanting to support medical device molders' 510(k) efforts will offer them a thoroughly documented package of GLP-compliant ISO 10993 biocompatibility data, including all of the testing required for the extent of patient exposure that may be characteristic of the device applications for which the material may be utilized. FDA Bluebook G95-1 would be the primary guidance for that.

That biocompatibility may have to be studied in relation to exposure to various other device and pharma materials that may create materials interactions. Anything that the resin supplier hasn't already studied that the user wants to do, the user will have to study.

Either study data or some other basis for establishment of compatibility with sterilization methods also is likely to be needed.

Your role as an upstream material supplier would be to establish your materials' biocompatibility and stability, again per ISO 10993, and prove via valid testing that likely materials combinations and processing conditions would not adversely affect that biocompability and stability.

Liability? If you're scared by liability, you may not be a good fit in the medical device world. Your liability is more or less unlimited, except by your efforts to avoid ever screwing up or being unlucky, or selling to customers who screw up or are unlucky. If you somehow contribute to a patient's adverse outcome, and you have any money, both the patient's estate and your downstream users will come after you. If your biocompability data turns out to be wrong, the FDA will come after you. You can protect yourself a little bit by writing good contracts and still getting customers to buy from you, and by never selling to customers that are a lot larger than you and thereby can hire bigger lawyers.

Material biocompatibility and stability documentation requirements are essentially equal in the US and Europe at present. Liability issues are a little different...your law firm is a better guide on that than we can be.

 

[keen_reader_RA]

Hello All,

I had a question on similar lines as asked in this thread. What are the factors to be considered if a raw material supplier is opting for an ISO 13485:2016 certification.
Example: If a supplier of medical grade plastic were to undergo ISO 13485 certification; then my assumption would be, that he needs to consider the applications it will be used under? My point of contention here is if he supplies raw material to say 10 (or more) medical device manufacturers then would the scope of certification include all of those?

What are your thoughts?

Let me know!

 

[somashekar]

Hello All,

I had a question on similar lines as asked in this thread. What are the factors to be considered if a raw material supplier is opting for an ISO 13485:2016 certification.
Example: If a supplier of medical grade plastic were to undergo ISO 13485 certification; then my assumption would be, that he needs to consider the applications it will be used under? My point of contention here is if he supplies raw material to say 10 (or more) medical device manufacturers then would the scope of certification include all of those?

What are your thoughts?

Let me know!

Such a supply chain would not need the 13485, because the service provided is not a medical device under the definations in 13485.
If you approach a CB and if they are willing to certify to 13485., then its more of CB business rather than client education.
A good understanding of the 13485 requirements and sincere application of the 9001 will suffice...

 

[keen_reader_RA]

Thank you so much for the prompt response!
Would the same logic hold true for manufacturer of sub-assemblies which fits into a medical device (not manufactured by this vendor)?
Also, the Introduction - General section of the standard does include this:

The requirements in this International Standard can also be used by suppliers or other external parties providing product (e.g. raw materials, components, sub assemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to such organizations.

Can above be interpreted as such a supplier could go for certification?

 

[somashekar]

Unless its a business requirement, voluntarily any supplier can use this standard.
If you can see good business prospect with this standard certification, you can opt for the same.
However my thoughts are as I have said above in post #5.
When you see the 1. Scope at page 1 of the standard, and relate to your activity, you may realize that the ISO 9001 addresses equally well or more.