Packaging

In FDA's 510(k) change guidance, packaging changes are assessed mainly for their effect on sterility and shelf life. For sterile devices, the sterile barrier system is part of the safety of the device and needs validation, including after transport.

Any wrapping, containers, etc., used to protect, to preserve the sterility of, or to group medical devices.

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