10993-18 requirements - Well known materials

[Judy Abbott]

I am working on a Polypropylene monofilament dyed with blue colorant - [Phthalocyaninato(2-)] Copper, < 0.5% (w /w). I am trying to complete the chemical characterization per 10993-18 without performing an E&L study.

My justification is based on the following:
blue monofilament polypropylene (PP), certified to meet the limits of USP Class VI. T
The pigment conforms to 21 CFR 74.3045 and the amount of pigment does not exceed 0.5% (w/w) of the material.
The materials are well known with a long history of safe use.

I wonder if such a rationale is sufficient to address 10993-18. Please share your thoughts.

 

[planB]

Judy,

what is the nature and duration of body exposure of your device according to ISO 10993-1:2018, section 5?

 

[yodon]

The materials are well known with a long history of safe use.

Not to say that it's not possible, but the counter arguments you'll likely need to address are (at least):

• Is the manufacturing process the same (release agents, cleaning, etc.)?
• Do the materials with the long history of safe use have the same colorant?
• Is the intended use (contact) the same as the intended use of the others?

Back in 2020, FDA published a guidance saying that biocompatibility testing may not be necessary if you can demonstrate there is no risk. I've yet to see a reviewer, though, not jump immediately into biocompatibility questions and ask for test data. If you go that route, expect an uphill battle.

 

[Ronen E]

Polypropylene monofilament dyed with blue colorant

Just for context, it sounds like a surgical suture, probably extruded (i.e. injection moulding aspects are probably irrelevant).

Two more points to contemplate:
- There may be a Drug Master File for this material at the FDA
- The material may be considered GRAS (Generally Regarded As Safe) by the FDA

...if indeed it's regarded as "a material" (or substance) and not a device/product.

 

[Judy Abbott]

Judy,

what is the nature and duration of body exposure of your device according to ISO 10993-1:2018, section 5?

Permanent contact with tissue

 

[Judy Abbott]

Not to say that it's not possible, but the counter arguments you'll likely need to address are (at least):

• Is the manufacturing process the same (release agents, cleaning, etc.)?
• Do the materials with the long history of safe use have the same colorant?
• Is the intended use (contact) the same as the intended use of the others?

Back in 2020, FDA published a guidance saying that biocompatibility testing may not be necessary if you can demonstrate there is no risk. I've yet to see a reviewer, though, not jump immediately into biocompatibility questions and ask for test data. If you go that route, expect an uphill battle.

Exactly! the manufacturing process is the same and all other risks are mitigated. However, I'm afraid the reviewers look only for test data.

 

[Judy Abbott]

Just for context, it sounds like a surgical suture, probably extruded (i.e. injection moulding aspects are probably irrelevant).

Two more points to contemplate:
- There may be a Drug Master File for this material at the FDA
- The material may be considered GRAS (Generally Regarded As Safe) by the FDA

...if indeed it's regarded as "a material" (or substance) and not a device/product.

Thank you!

 

[planB]

Judy,

in case you have _enough_ data on file that

1. your base material consists only polypropylene without relevant contaminants from manufacturing, and
2. your colour pigment indeed conforms to 21 CFR 74.3045,

you might be in a position to demonstrate biological equivalence to similar sutures on the market.

Just be aware that USP VI compliance is not sufficient to address all biological endpoints for long-term tissue-contacting devices per in ISO 10993-1:2018, Table A.1. And the colorant is under some regulatory scrutiny in Europe, at least for tattoo inks and cosmetics.

Good luck and I would be keen to hear back from your "uphill battle" ( © @yodon )!

 

[Judy Abbott]

Judy,

in case you have _enough_ data on file that

1. your base material consists only polypropylene without relevant contaminants from manufacturing, and
2. your colour pigment indeed conforms to 21 CFR 74.3045,

you might be in a position to demonstrate biological equivalence to similar sutures on the market.

Just be aware that USP VI compliance is not sufficient to address all biological endpoints for long-term tissue-contacting devices per in ISO 10993-1:2018, Table A.1. And the colorant is under some regulatory scrutiny in Europe, at least for tattoo inks and cosmetics.

Good luck and I would be keen to hear back from your "uphill battle" ( © @yodon )!

Thank you very much for your valuable feedback.

 

[QMS PNW]

Hi Judy, I tried to take the justification route for a permanent tissue contact device, and 3 independent consultants, 2 of which used to be FDA reviewers, indicated FDA Biocompatibility team is the most checklist oriented, least flexible team. 10993 is a safety standard, afterall. I am convinced it is faster for your schedule to do all the testing on your device, unless you have raw data to submit of a suitable surrogate device. Otherwise expect deficiencies that require testing. Apparently FDA got burned in the past for passing an orthopedic implant based on rationales, and after MDRs in the field and a major recall, FDA has become more conservative.