USP Class & Compliance Selector

A starting-point indicator of the USP biological-reactivity class a device material is typically evaluated against, based on contact type and duration. It points you to the right conversation — it is not a regulatory determination.

USP Class VI evaluates biological reactivity via systemic injection, intracutaneous, and implantation tests. ISO 10993 is broader and adds materials risk management; a Class VI material can also meet ISO 10993, but Class VI alone is not ISO 10993 compliance. There is no “FDA-approved” plastic — the FDA evaluates the finished device. Confirm the path with your regulatory team.