FDA compliance.
USP Class VI.
Medical materials.
FDA and USP Class VI material reference. Different applications, different requirements. Documentation, testing, certification.
Key principles.
Adhesives
Food contact adhesives. Specific approval list.
Food contact
Food contact materials. Most plastics here.
Additives
Food additive materials. Specific list.
Implants
Implant biocompatibility testing. PEEK-OPTIMA, USP silicone.
Premium
Some materials cover both — premium documentation.
Per heat lot
Material cert traceable to mill heat.
FAQ
FDA vs USP VI?
FDA 21 CFR: food contact materials. USP VI: implant biocompatibility testing. Different applications.
PEEK-OPTIMA importance?
Invibio PEEK-OPTIMA USP Class VI. Standard for spinal cages, orthopedic implants.
USP Class VI testing?
Systemic toxicity, intracutaneous reaction, intramuscular implantation per USP.
Documentation?
Material certificates, processing records, inspection per AS9102 or PPAP.
Sterilization compatibility?
Most USP VI materials autoclave-compatible. Verify per material grade and method.
Cost premium?
USP VI materials 1.5-3× standard equivalent. Documentation adds 10-20%.
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