21 U.S.C. § 360e–4 — Predetermined change control plans for devices

(a) Approved devices If a device was approved under section 360e, its maker doesn't need to file a supplemental application for a later change, as long as that change follows a "predetermined change control plan" the Secretary already approved. The Secretary may approve such a plan — submitted with an application or supplemental application — if it describes changes the maker might make later (changes that would otherwise require a new supplemental application), so long as the device stays safe and effective without needing to make that change. The Secretary can require the plan to include labeling for the device as it changes under the plan, rules for notifying the Secretary if the device doesn't work as intended, and performance requirements for each change made under the plan. (b) Cleared devices The same idea applies to devices cleared under section 360(k): no new premarket notification is required for a change that follows an established predetermined change control plan. The Secretary may clear such a plan, submitted in a notification, if (A) the device stays safe and effective without the change, and (B) the device would stay substantially equivalent to its predicate device even after the change. Again, the Secretary can require the plan to cover labeling, notification requirements if the device doesn't function as intended, and performance requirements for each change. (c) Predicate devices When deciding whether a device is "substantially equivalent" to an earlier one, the Secretary cannot compare it to a changed version of a device that resulted from a predetermined change control plan. Only the version of the device that was cleared or approved before any plan-driven changes may be used by a sponsor as the predicate (comparison) device.