§360e–4 Predetermined Change Control Plans for Devices

Summary

Lets device makers skip a new approval or 510(k) when they want to make planned changes, as long as those changes match an approved "predetermined change control plan." A predetermined change control plan is a short plan that says what changes may be made and how they will be done. Companies can put that plan in their original or supplemental application or in a 510(k). The FDA can approve or clear the plan if the device stays safe and effective after the changes, and for 510(k) devices the device must also stay substantially equivalent to its predicate. The FDA can require the plan to include updated labeling, reporting if the device fails because of the change, and performance checks. When deciding if a new device is substantially equivalent to an older one, the FDA must use only the version that was cleared or approved before any changes made under an approved plan.