---
kind: "section"
citation: "21 U.S.C. § 360e–4"
title: "21"
title_heading: "Food and Drugs"
number: "360e–4"
heading: "Predetermined change control plans for devices"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360e-4"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §360e–4. Predetermined change control plans for devices

- (a) **Approved devices—**
  - (1) **In general—** Notwithstanding [section 360e(d)(5)(A) of this title](/usc/21/360e.md?p=d-5-A), a supplemental application shall not be required for a change to a [device](/usc/21/321.md?p=h-1) approved under [section 360e of this title](/usc/21/360e.md), if such change is consistent with a predetermined change control plan that is approved pursuant to [paragraph (2)](#a-2).
  - (2) **Predetermined change control plan—** The [Secretary](/usc/21/321.md?p=d) may approve a predetermined change control plan submitted in an application, including a supplemental application, under [section 360e of this title](/usc/21/360e.md) that describes planned changes that may be made to the [device](/usc/21/321.md?p=h-1) (and that would otherwise require a supplemental application under [section 360e of this title](/usc/21/360e.md)), if the [device](/usc/21/321.md?p=h-1) remains [safe](/usc/21/321.md?p=u) and effective without any change.
  - (3) **Scope—** The [Secretary](/usc/21/321.md?p=d) may require that a change control plan include [labeling](/usc/21/321.md?p=m) required for [safe](/usc/21/321.md?p=u) and effective use of the [device](/usc/21/321.md?p=h-1) as such [device](/usc/21/321.md?p=h-1) changes pursuant to such plan, notification requirements if the [device](/usc/21/321.md?p=h-1) does not function as intended pursuant to such plan, and performance requirements for changes made under the plan.
- (b) **Cleared devices—**
  - (1) **In general—** Notwithstanding [section 360(k) of this title](/usc/21/360.md?p=k), a premarket notification shall not be required for a change to a [device](/usc/21/321.md?p=h-1) cleared under [section 360(k) of this title](/usc/21/360.md?p=k), if such change is consistent with an established predetermined change control plan granted pursuant to [paragraph (2)](#b-2).
  - (2) **Predetermined change control plan—** The [Secretary](/usc/21/321.md?p=d) may clear a predetermined change control plan submitted in a notification submitted under [section 360(k) of this title](/usc/21/360.md?p=k) that describes planned changes that may be made to the [device](/usc/21/321.md?p=h-1) (and that would otherwise require a new notification), if—
    - (A) the [device](/usc/21/321.md?p=h-1) remains [safe](/usc/21/321.md?p=u) and effective without any such change; and
    - (B) the [device](/usc/21/321.md?p=h-1) would remain substantially equivalent to the predicate.
  - (3) **Scope—** The [Secretary](/usc/21/321.md?p=d) may require that a change control plan include [labeling](/usc/21/321.md?p=m) required for [safe](/usc/21/321.md?p=u) and effective use of the [device](/usc/21/321.md?p=h-1) as such [device](/usc/21/321.md?p=h-1) changes pursuant to such plan, notification requirements if the [device](/usc/21/321.md?p=h-1) does not function as intended pursuant to such plan, and performance requirements for changes made under the plan.
- (c) **Predicate devices—** In making a determination of substantial equivalence pursuant to [section 360c(i) of this title](/usc/21/360c.md?p=i), the [Secretary](/usc/21/321.md?p=d) shall not compare a [device](/usc/21/321.md?p=h-1) to changed versions of a [device](/usc/21/321.md?p=h-1) implemented in accordance with an established predetermined change control plan as a predicate [device](/usc/21/321.md?p=h-1). Only the version of the [device](/usc/21/321.md?p=h-1) cleared or approved, prior to changes made under the predetermined change control plan, may be used by a [sponsor](/usc/21/360fff.md?p=8) as a predicate [device](/usc/21/321.md?p=h-1).

## Source credit

(June 25, 1938, ch. 675, § 515C, as added Pub. L. 117–328, div. FF, title III, § 3308(a), Dec. 29, 2022, 136 Stat. 5835.)

## Notes

### 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.