Environmental specifications

In FDA's 510(k) change guidance, widening the operating conditions is a design change that needs assessment and usually testing. The manufacturer decides whether it could significantly affect safety or effectiveness and documents the outcome.

The (range of) acceptable levels of environmental parameters or operating conditions under which the device will perform safely and effectively. Examples of changes in environmental specifications are expanding the acceptable temperature range in which the device will operate properly or hardening the device to significantly higher levels of electromagnetic interference.

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