I 
112TH CONGRESS 
2D SESSION 
H. R. 3847 
To amend the Federal Food, Drug, and Cosmetic Act to ensure that a 
medical device is not marketed based on a determination that the device 
is substantially equivalent to a predicate device that has been recalled, 
corrected, or removed from the market because of an intrinsic flaw 
in technology or design that adversely affects safety, and for other 
purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 31, 2012 
Mr. MARKEY (for himself, Mr. WAXMAN, Ms. SCHAKOWSKY, and Ms. 
DELAURO) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
ensure that a medical device is not marketed based on 
a determination that the device is substantially equiva-
lent to a predicate device that has been recalled, cor-
rected, or removed from the market because of an intrin-
sic flaw in technology or design that adversely affects 
safety, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Safety Of Untested 
and New Devices Act of 2012’’ or the ‘‘SOUND Devices 
Act of 2012’’. 
SEC. 2. PREDICATE DEVICES THAT HAVE BEEN RECALLED, 
CORRECTED, OR REMOVED FROM THE MAR-
KET. 
(a) SUBMISSION
OF INFORMATION
BY PERSONS 
SEEKING
SUBSTANTIAL
EQUIVALENCE
DETERMINA-
TION.—Section 513(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360c(i)) is amended— 
(1) by redesignating paragraph (3) as para-
graph (5); and 
(2) by striking paragraph (2) and inserting the 
following: 
‘‘(2)(A) Any person seeking a determination of sub-
stantial equivalence under subsection (f) or section 520(l) 
for a device shall submit to the Secretary information (to 
the extent such information is readily available) on the 
market status of— 
‘‘(i) each predicate device; and 
‘‘(ii) each device in the full device lineage (as 
defined in subparagraph (C)). 
‘‘(B) With respect to each device described in clause 
(i) or (ii) of subparagraph (A), the information required 
to be submitted under subparagraph (A) shall specify— 
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‘‘(i) whether the device has been corrected or 
removed from the market; 
‘‘(ii) if so, the basis for such correction or re-
moval, including whether such correction or removal 
was because of an intrinsic flaw in technology or de-
sign that adversely affects safety; and 
‘‘(iii) why the device for which a substantial 
equivalence determination is sought does not share 
any such intrinsic flaw. 
‘‘(C) In this paragraph, the term ‘device in the full 
device lineage’ means a device for which a substantial 
equivalence determination was made leading to a substan-
tial equivalence determination for a predicate device re-
ferred to in subparagraph (A)(i).’’. 
(b) REJECTING CLAIMS OF SUBSTANTIAL EQUIVA-
LENCE.—Section 513(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360c(i)), as amended, is further 
amended by inserting after paragraph (2) the following: 
‘‘(3) The Secretary— 
‘‘(A) shall not find a device to be substantially 
equivalent to a predicate device that has been— 
‘‘(i) removed from the market at the initia-
tive of the Secretary; or 
‘‘(ii) determined to be misbranded or adul-
terated by judicial order; 
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‘‘(B) may reject a claim that a device is sub-
stantially equivalent to a predicate device if— 
‘‘(i) the predicate device, or any device in 
a series of one or more devices for which a sub-
stantial equivalence determination was made 
leading to a substantial equivalence determina-
tion for the predicate device, has been corrected 
or removed from the market— 
‘‘(I) at the initiative of the sponsor; or 
‘‘(II) under any other circumstance 
not covered by subparagraph (A); and 
‘‘(ii) the correction or removal is due, in 
whole or in part, to an intrinsic flaw in tech-
nology or design that adversely affects safety; 
‘‘(C) may reject a claim that a device is sub-
stantially equivalent to a predicate device if— 
‘‘(i) the Secretary is in the process of re-
scinding the clearance granted under section 
510(k), issuing or amending an order under 
section 518(e) (relating to recall authority), or 
taking any other regulatory action because of 
an intrinsic flaw in technology or design that 
adversely affects safety, with respect to— 
‘‘(I) the predicate device; or 
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‘‘(II) any device in the full predicate 
device lineage (meaning any device for 
which a substantial equivalence determina-
tion was made leading to a substantial 
equivalence determination for the predicate 
device); or 
‘‘(ii) the manufacturer or importer of a de-
vice described in subclause (I) or (II) of clause 
(i) is in the process of correcting or removing 
the device from the market; and 
‘‘(D) may reject a claim that a device is sub-
stantially equivalent to a predicate device if the 
predicate device has been corrected or removed from 
the market and the manufacturer or importer of the 
predicate failed to submit notice of such correction 
or removal in accordance with section 519(g).’’. 
(c) DATABASE ON ELIGIBLE PREDICATE DEVICES.— 
Section 513(i) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360c(i)), as amended, is further amended 
by inserting after paragraph (3) the following: 
‘‘(4)(A) The Secretary shall maintain an up-to-date 
database that can be used by the Secretary for purposes 
of determining whether devices are eligible under para-
graph (3) for use as a predicate device. 
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‘‘(B) The Secretary shall determine whether a device 
is eligible under paragraph (3) for use as a predicate de-
vice, and shall make appropriate updates to the database 
under this paragraph, whenever— 
‘‘(i) the Secretary issues, vacates, or amends an 
order for a device under section 518(e) (relating to 
recall authority); 
‘‘(ii) the manufacturer or importer of a device 
reports a correction or removal of a device under 
subsection (g) or (h) of section 519; or 
‘‘(iii) the Secretary otherwise learns of a correc-
tion or removal of a device (as such terms are used 
in subsections (g) and (h) of section 519). 
‘‘(C) Upon making a determination required by sub-
paragraph (B), the Secretary shall include in the database 
under this paragraph information, to the extent such in-
formation is available to the Secretary, about the reason 
for the order, correction, or removal. 
‘‘(D) The Secretary shall publish notice of each deter-
mination under subparagraph (B).’’. 
(d) REPORTS OF CORRECTIONS AND REMOVALS.— 
(1) IN GENERAL.—Section 519 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is 
amended by adding at the end the following: 
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‘‘(h) INCLUSION OF ROOT CAUSE ANALYSIS IN RE-
PORTS OF REMOVALS AND CORRECTIONS.— 
‘‘(1) REQUIREMENT.—Whenever a manufac-
turer or importer of a device is required to submit 
a report under subsection (g) on a corrective action 
or removal of the device, and whenever a manufac-
turer or importer would be so required but for sub-
mitting a report under subsection (a) on a corrective 
action or removal of the device, the manufacturer or 
importer shall submit, as an addendum to the sub-
mitted report, the root cause assessment of each de-
vice defect leading to the corrective action or re-
moval. 
‘‘(2) TIMING.—An addendum required by para-
graph (1) shall be submitted to the Secretary 
promptly, and not later than 90 days after the cor-
rective action or removal.’’. 
(2) REPORTS FOR DEVICES IN SAME LINEAGE 
AS DEVICES SUBJECT TO CORRECTIONS AND REMOV-
ALS.— 
(A) AUTHORITY
TO
ORDER
REPORTS.— 
Section 519 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360i), as amended, is 
further amended by adding at the end the fol-
lowing: 
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‘‘(i) REPORTS FOR DEVICES IN SAME LINEAGE AS 
DEVICES SUBJECT TO CORRECTIONS AND REMOVALS.— 
‘‘(1) IN GENERAL.—When a device is corrected 
or removed from the market because of an intrinsic 
flaw in technology or design that adversely affects 
safety— 
‘‘(A) the Secretary may order the manu-
facturer or importer of each device in the same 
lineage which continues to be marketed to sub-
mit a report described in paragraph (2); and 
‘‘(B) not later than 30 days after receipt 
of such an order, the manufacturer or importer 
of each such device shall submit the report. 
‘‘(2) REPORT CONTENTS.—A report described 
in this paragraph shall— 
‘‘(A) state whether the device for which the 
report is submitted shares any intrinsic flaw in 
technology or design associated with the device 
which is corrected or removed from the market; 
and 
‘‘(B) if not, explain why the device for 
which the report is submitted does not share 
any such intrinsic flaw. 
‘‘(3) DEFINITION.—In this subsection, the term 
‘device in the same lineage’ refers to a device if— 
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‘‘(A) a substantial equivalence determina-
tion was made for the device corrected or re-
moved from the market; and 
‘‘(B) such determination leads to a sub-
stantial equivalence determination for the device 
involved.’’. 
(B) CONFORMING
AMENDMENT.—Section 
303(f)(1)(B) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 333(f)(1)(B)) is 
amended by striking ‘‘or 519(g)’’ and inserting 
‘‘, 519(g), or 519(h)’’. 
(e) REVIEW OF PREVIOUSLY CLEARED LIFE-SUS-
TAINING, LIFE-SUPPORTING, 
OR
IMPLANTABLE
DE-
VICES.— 
(1) REVIEW.—The Secretary shall conduct a re-
view of all covered devices to identify any such de-
vices with respect to which a predicate device, or any 
device in the full device lineage, has been corrected 
or removed from the market pursuant to a Class I 
or Class II recall. 
(2) PRIORITY.—In conducting the review under 
paragraph (1), the Secretary shall prioritize— 
(A) the review of covered devices that pose 
the highest risk to patients; and 
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(B) the identification of covered devices 
that share with another device an intrinsic flaw 
in technology or design that— 
(i) adversely affects safety; and 
(ii) led to the correction or removal 
from the market of the other device. 
(3) REPORT.—Not later than 3 years after the 
date of the enactment of this Act, the Secretary 
shall submit a report to the Congress on the 
progress made by the Secretary in implementing this 
subsection. 
(4) DEFINITIONS.—In this subsection: 
(A) The terms ‘‘Class I’’, ‘‘Class II’’, and 
‘‘recall’’ have the meanings given to such terms 
in section 7.3 of title 21, Code of Federal Regu-
lations (or any successor regulations). 
(B) The term ‘‘covered device’’ means a 
device (as defined in section 201 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
321)) that— 
(i) is cleared under section 510(k) of 
such Act (21 U.S.C. 360(k)) before the ef-
fective date of the amendments made by 
subsections (a) through (d); 
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(ii) is life-sustaining, life-supporting, 
or implantable; and 
(iii) continues to be marketed. 
(C) The term ‘‘device in the full device lin-
eage’’ means a device for which a substantial 
equivalence determination was made leading to 
a substantial equivalence determination for a 
predicate device referred to in paragraph (1). 
(D) The term ‘‘Secretary’’ means the Sec-
retary of Health and Human Services, acting 
through the Commissioner of Food and Drugs. 
Æ 
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