§ 360e–4 — Predetermined Change Control Plans For Devices

(1) Notwithstanding section 360e(d)(5)(A) of this title, a supplemental application shall not be required for a change to a device approved under section 360e of this title, if such change is consistent with a predetermined change control plan that is approved pursuant to paragraph (2). (2) The Secretary may approve a predetermined change control plan submitted in an application, including a supplemental application, under section 360e of this title that describes planned changes that may be made to the device (and that would otherwise require a supplemental application under section 360e of this title), if the device remains safe and effective without any change. (3) The Secretary may require that a change control plan include labeling required for safe and effective use of the device as such device changes pursuant to such plan, notification requirements if the device does not function as intended pursuant to such plan, and performance requirements for changes made under the plan. (1) Notwithstanding section 360(k) of this title, a premarket notification shall not be required for a change to a device cleared under section 360(k) of this title, if such change is consistent with an established predetermined change control plan granted pursuant to paragraph (2). (2) The Secretary may clear a predetermined change control plan submitted in a notification submitted under section 360(k) of this title that describes planned changes that may be made to the device (and that would otherwise require a new notification), if— (A) the device remains safe and effective without any such change; and (B) the device would remain substantially equivalent to the predicate. (3) The Secretary may require that a change control plan include labeling required for safe and effective use of the device as such device changes pursuant to such plan, notification requirements if the device does not function as intended pursuant to such plan, and performance requirements for changes made under the plan. (c) In making a determination of substantial equivalence pursuant to section 360c(i) of this title, the Secretary shall not compare a device to changed versions of a device implemented in accordance with an established predetermined change control plan as a predicate device. Only the version of the device cleared or approved, prior to changes made under the predetermined change control plan, may be used by a sponsor as a predicate device.