Method of sterilization

In FDA's 510(k) change guidance, moving to a different sterilization method is a change that needs careful assessment, because it can affect materials, residues and the sterility claim. Validation of the new method and its effect on materials and packaging are the main points to check.

The physical or chemical mechanism used to achieve sterility or to achieve a specific sterility assurance level (SAL).

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