View all text of Part A [§ 351 - § 360n-2]
§ 360e–4. Predetermined change control plans for devices
(a) Approved devices
(1) In general
(2) Predetermined change control plan
(3) Scope
(b) Cleared devices
(1) In general
(2) Predetermined change control plan
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) Scope
(c) Predicate devices
(June 25, 1938, ch. 675, § 515C, as added Pub. L. 117–328, div. FF, title III, § 3308(a), Dec. 29, 2022, 136 Stat. 5835.)