Material type

In the 510(k) change guidance, a change in material type is a bigger step than a change in formulation. Moving from one kind of material to another usually calls for a fresh look at biocompatibility and performance before deciding whether a new 510(k) is needed.

The generic name of the material from which the device is manufactured. An example of a material type change would be the change from natural latex rubber to synthetic rubber.

FDA guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (October 2017), Appendix C, Significant Terminology