Material formulation

FDA's guidance on when to submit a 510(k) for a change uses this term to separate real material changes from changes in manufacturing aids. Whether a new formulation needs a new 510(k) depends mainly on whether the material contacts the body and how the change affects biocompatibility and performance.

The base formulation of a polymer, alloy, etc., plus any additives, colors, etc., used to establish a property or the stability of the material. This does not include processing aids, mold release agents, residual contaminants, or other manufacturing aids that are not intended to be a part of the material, but that could be present as impurities on the final device. An example of a change in material formulation would be a change from a series 300 stainless steel to a series 400 stainless steel. Another example of a change in material formulation would be the addition or subtraction of a chemical or compound to or from a polymer.

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