§360e–4 Predetermined Change Control Plans for Devices

Summary

Allows device makers to use an approved "predetermined change control plan" to make planned changes without filing a new application for approved devices or a new premarket notification for cleared devices. The FDA can approve or clear such a plan if the device stays safe and effective and, for cleared devices, would remain substantially equivalent to its original predicate. The FDA can require updated labels, performance checks, and rules for notifying if the device stops working as intended. When the FDA decides if a device is substantially equivalent to a predicate, it must use only the original cleared or approved version. Versions changed under an approved plan cannot be used as the predicate.