§360e–4 — Title 21 Food and Drugs | U.S. Code

Summary

Allows a device maker to avoid filing a new approval or a new notification for planned changes if the changes follow an approved predetermined change control plan. The Secretary can approve such a plan for devices approved under the full approval process or cleared under the 510(k) process, as long as the device stays safe and effective. For cleared devices, the device must also stay substantially equivalent to its original predicate. The Secretary can require updated labels, notices if the device fails to work, and performance checks as part of the plan. When deciding if another device is substantially equivalent, the Secretary cannot use a version of a device that was changed under one of these plans as the predicate. Only the original cleared or approved version before those planned changes may be used as the predicate device.

Title 21, §360e–4

Food and Drugs — Source: USLM XML via OLRC

(a)(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.

(b)(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.

(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.

Editorial Notes

Prior Provisions

A prior section 515C of act June 25, 1938, was renumbered section 515B and is classified to section 360e–3 of this title.

§360e–4 Predetermined change control plans for devices

Summary

Title 21, §360e–4

Notes & Related Subsidiaries

Editorial Notes

Prior Provisions

Citations & Metadata