II 

117TH CONGRESS 

2D SESSION S. 4386 

To allow for devices with a predetermined change control plan to be marketed 

without submitting a supplemental application or premarket notification 

if the changes to such devices are consistent with such plan. 

IN THE SENATE OF THE UNITED STATES 

JUNE 13, 2022 

Mr. BRAUN (for himself and Mr. HICKENLOOPER) introduced the following 

bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To allow for devices with a predetermined change control 

plan to be marketed without submitting a supplemental 

application or premarket notification if the changes to 

such devices are consistent with such plan. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. PREDETERMINED CHANGE CONTROL PLANS 

4 FOR DEVICES. 

5 (a) IN GENERAL.—Chapter V of the Federal Food, 

6 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend7 ed by inserting after section 515B (21 U.S.C. 360e–3) the 

8 following: 


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1 ‘‘SEC. 515C. PREDETERMINED CHANGE CONTROL PLANS 

2 FOR DEVICES. 

3 ‘‘(a) APPROVED DEVICES.— 

4 ‘‘(1) IN GENERAL.—Notwithstanding section 

5 515(d)(5)(A), a supplemental application shall not 

6 be required for a change to a device approved under 

7 section 515, if such change is consistent with a pre8 determined change control plan that is approved 

9 pursuant to paragraph (2). 

10 ‘‘(2) PREDETERMINED CHANGE CONTROL

11 PLAN.—The Secretary may approve a predetermined 

12 change control plan submitted in an application, in13 cluding a supplemental application, under section 

14 515 that describes planned changes that may be 

15 made to the device (and that would otherwise re16 quire a supplemental application under section 515), 

17 if the device remains safe and effective without any 

18 change. 

19 ‘‘(3) SCOPE.—The Secretary may require that a 

20 change control plan include labeling required for 

21 safe and effective use of the device as such device 

22 changes pursuant to such plan, notification require23 ments if the device does not function as intended 

24 pursuant to such plan, and performance require25 ments for changes made under the plan. 

26 ‘‘(b) CLEARED DEVICES.— 


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•S 4386 IS

1 ‘‘(1) IN GENERAL.—Notwithstanding section 

2 510(k), a premarket notification shall not be re3 quired for a change to a device cleared under section 

4 510(k), if such change is consistent with an estab5 lished predetermined change control plan granted 

6 pursuant to paragraph (2). 

7 ‘‘(2) PREDETERMINED CHANGE CONTROL

8 PLAN.—The Secretary may clear a predetermined 

9 change control plan submitted in a notification sub10 mitted under section 510(k) that describes planned 

11 changes that may be made to the device (and that 

12 would otherwise require a new notification), if— 

13 ‘‘(A) the device remains safe and effective 

14 without any such change; and 

15 ‘‘(B) the device would remain substantially 

16 equivalent to the predicate. 

17 ‘‘(3) SCOPE.—The Secretary may require that a 

18 change control plan include labeling required for 

19 safe and effective use of the device as such device 

20 changes pursuant to such plan, notification require21 ments if the device does not function as intended 

22 pursuant to such plan, and performance require23 ments for changes made under the plan. 

24 ‘‘(c) PREDICATE DEVICES.—In making a determina25 tion of substantial equivalence pursuant to section 513(i), 


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•S 4386 IS

1 the Secretary shall not compare a device to changed 

2 versions of a device implemented in accordance with an 

3 established predetermined change control plan as a predi4 cate device. Only the version of the device cleared or ap5 proved, prior to changes made under the predetermined 

6 change control plan, may be used by a sponsor as a predi7 cate device.’’. 

8 (b) CONFORMING AMENDMENTS.— 

9 (1) CLEARED DEVICES.—Section 510(l)(1) of 

10 the Federal Food, Drug, and Cosmetic Act (21 

11 U.S.C. 360(l)(1)) is amended, in the first sentence, 

12 by inserting ‘‘, or with respect to a change that is 

13 consistent with a predetermined change control plan 

14 cleared under section 515C’’ before the period at the 

15 end. 

16 (2) APPROVED DEVICES.—Section 

17 515(d)(5)(A)(i) of the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 360e(d)(5)(A)(i)) is amended 

19 by striking ‘‘A supplemental’’ and inserting ‘‘Unless 

20 the change is consistent with a predetermined 

21 change control plan approved under section 515C, a 

22 supplemental’’. 

23 (3) DOCUMENTATION OF RATIONALE FOR SIG24 NIFICANT DECISIONS.—Section 517A(a)(1) of the 


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•S 4386 IS

1 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

2 360g–1(a)(1)) is amended to read as follows: 

3 ‘‘(1) IN GENERAL.—The Secretary shall provide 

4 a substantive summary of the scientific and regu5 latory rationale for any significant decision of the 

6 Center for Devices and Radiological Health regard7 ing submission or review of a report under section 

8 510(k), a petition for classification under section 

9 513(f), an application under section 515, or an ap10 plication for an exemption under section 520(g), in11 cluding documentation of significant controversies or 

12 differences of opinion and the resolution of such con13 troversies or differences of opinion.’’. 

Æ 


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