US Code

Public Law 119-73 (01/23/2026)

21 U.S.C. § 360e–4

Predetermined change control plans for devices

(a)

Approved devices

(1)

In general

section 360e(d)(5)(A) of this titlesection 360e of this titleNotwithstanding , a supplemental application shall not be required for a change to a device approved under , if such change is consistent with a predetermined change control plan that is approved pursuant to paragraph (2).

(2)

Predetermined change control plan

section 360e of this titlesection 360e of this titleThe Secretary may approve a predetermined change control plan submitted in an application, including a supplemental application, under that describes planned changes that may be made to the device (and that would otherwise require a supplemental application under ), if the device remains safe and effective without any change.

(3)

Scope

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)

Cleared devices

(1)

In general

section 360(k) of this titlesection 360(k) of this titleNotwithstanding , a premarket notification shall not be required for a change to a device cleared under , if such change is consistent with an established predetermined change control plan granted pursuant to paragraph (2).

(2)

Predetermined change control plan

section 360(k) of this titleThe Secretary may clear a predetermined change control plan submitted in a notification submitted under 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)

Scope

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)

Predicate devices

section 360c(i) of this titleIn making a determination of substantial equivalence pursuant to , 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.

June 25, 1938, ch. 675, § 515CPub. L. 117–328, div. FF, title III, § 3308(a)136 Stat. 5835(, as added , , .)

Editorial Notes

Prior Provisions

section 360e–3 of this titleA prior section 515C of act , was renumbered section 515B and is classified to .