I 
117TH CONGRESS 
2D SESSION 
H. R. 8299 
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 HOUSE OF REPRESENTATIVES 
JULY 7, 2022 
Mr. BILIRAKIS (for himself and Mr. O’HALLERAN) introduced the following 
bill; which was referred to the Committee on Energy and Commerce 
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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. PREDETERMINED CHANGE CONTROL PLANS 
FOR DEVICES. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 515B (21 U.S.C. 360e–3) the 
following: 
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‘‘SEC. 515C. PREDETERMINED CHANGE CONTROL PLANS 
FOR DEVICES. 
‘‘(a) APPROVED DEVICES.— 
‘‘(1) IN
GENERAL.—Notwithstanding section 
515(d)(5)(A), a supplemental application shall not 
be required for a change to a device approved under 
section 515, if such change is consistent with a pre-
determined change control plan that is approved 
pursuant to paragraph (2). 
‘‘(2) 
PREDETERMINED
CHANGE
CONTROL 
PLAN.—The Secretary may approve a predetermined 
change control plan submitted in an application, in-
cluding a supplemental application, under section 
515 that describes planned changes that may be 
made to the device (and that would otherwise re-
quire a supplemental application under section 515), 
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 require-
ments if the device does not function as intended 
pursuant to such plan, and performance require-
ments for changes made under the plan. 
‘‘(b) CLEARED DEVICES.— 
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‘‘(1) IN
GENERAL.—Notwithstanding section 
510(k), a premarket notification shall not be re-
quired for a change to a device cleared under section 
510(k), if such change is consistent with an estab-
lished predetermined change control plan granted 
pursuant to paragraph (2). 
‘‘(2) 
PREDETERMINED
CHANGE
CONTROL 
PLAN.—The Secretary may clear a predetermined 
change control plan submitted in a notification sub-
mitted under section 510(k) 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 require-
ments if the device does not function as intended 
pursuant to such plan, and performance require-
ments for changes made under the plan. 
‘‘(c) PREDICATE DEVICES.—In making a determina-
tion of substantial equivalence pursuant to section 513(i), 
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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 predi-
cate device. Only the version of the device cleared or ap-
proved, prior to changes made under the predetermined 
change control plan, may be used by a sponsor as a predi-
cate device.’’. 
(b) CONFORMING AMENDMENTS.— 
(1) CLEARED
DEVICES.—Section 510(l)(1) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360(l)(1)) is amended, in the first sentence, 
by inserting ‘‘, or with respect to a change that is 
consistent with a predetermined change control plan 
cleared under section 515C’’ before the period at the 
end. 
(2) 
APPROVED
DEVICES.—Section 
515(d)(5)(A)(i) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360e(d)(5)(A)(i)) is amended 
by striking ‘‘A supplemental’’ and inserting ‘‘Unless 
the change is consistent with a predetermined 
change control plan approved under section 515C, a 
supplemental’’. 
(3) DOCUMENTATION OF RATIONALE FOR SIG-
NIFICANT
DECISIONS.—Section 517A(a)(1) of the 
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Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360g–1(a)(1)) is amended to read as follows: 
‘‘(1) IN GENERAL.—The Secretary shall provide 
a substantive summary of the scientific and regu-
latory rationale for any significant decision of the 
Center for Devices and Radiological Health regard-
ing submission or review of a report under section 
510(k), a petition for classification under section 
513(f), an application under section 515, or an ap-
plication for an exemption under section 520(g), in-
cluding documentation of significant controversies or 
differences of opinion and the resolution of such con-
troversies or differences of opinion.’’. 
Æ 
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