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 Committee 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 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. 

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


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Safety Of Untested 

3 and New Devices Act of 2012’’ or the ‘‘SOUND Devices 

4 Act of 2012’’. 

5 SEC. 2. PREDICATE DEVICES THAT HAVE BEEN RECALLED, 

6 CORRECTED, OR REMOVED FROM THE MAR7 KET. 

8 (a) SUBMISSION OF INFORMATION BY PERSONS

9 SEEKING SUBSTANTIAL EQUIVALENCE DETERMINA10 TION.—Section 513(i) of the Federal Food, Drug, and 

11 Cosmetic Act (21 U.S.C. 360c(i)) is amended— 

12 (1) by redesignating paragraph (3) as para13 graph (5); and 

14 (2) by striking paragraph (2) and inserting the 

15 following: 

16 ‘‘(2)(A) Any person seeking a determination of sub17 stantial equivalence under subsection (f) or section 520(l) 

18 for a device shall submit to the Secretary information (to 

19 the extent such information is readily available) on the 

20 market status of— 

21 ‘‘(i) each predicate device; and 

22 ‘‘(ii) each device in the full device lineage (as 

23 defined in subparagraph (C)). 

24 ‘‘(B) With respect to each device described in clause 

25 (i) or (ii) of subparagraph (A), the information required 

26 to be submitted under subparagraph (A) shall specify— 


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1 ‘‘(i) whether the device has been corrected or 

2 removed from the market; 

3 ‘‘(ii) if so, the basis for such correction or re4 moval, including whether such correction or removal 

5 was because of an intrinsic flaw in technology or de6 sign that adversely affects safety; and 

7 ‘‘(iii) why the device for which a substantial 

8 equivalence determination is sought does not share 

9 any such intrinsic flaw. 

10 ‘‘(C) In this paragraph, the term ‘device in the full 

11 device lineage’ means a device for which a substantial 

12 equivalence determination was made leading to a substan13 tial equivalence determination for a predicate device re14 ferred to in subparagraph (A)(i).’’. 

15 (b) REJECTING CLAIMS OF SUBSTANTIAL EQUIVA16 LENCE.—Section 513(i) of the Federal Food, Drug, and 

17 Cosmetic Act (21 U.S.C. 360c(i)), as amended, is further 

18 amended by inserting after paragraph (2) the following: 

19 ‘‘(3) The Secretary— 

20 ‘‘(A) shall not find a device to be substantially 

21 equivalent to a predicate device that has been— 

22 ‘‘(i) removed from the market at the initia23 tive of the Secretary; or 

24 ‘‘(ii) determined to be misbranded or adul25 terated by judicial order; 


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1 ‘‘(B) may reject a claim that a device is sub2 stantially equivalent to a predicate device if— 

3 ‘‘(i) the predicate device, or any device in 

4 a series of one or more devices for which a sub5 stantial equivalence determination was made 

6 leading to a substantial equivalence determina7 tion for the predicate device, has been corrected 

8 or removed from the market— 

9 ‘‘(I) at the initiative of the sponsor; or 

10 ‘‘(II) under any other circumstance 

11 not covered by subparagraph (A); and 

12 ‘‘(ii) the correction or removal is due, in 

13 whole or in part, to an intrinsic flaw in tech14 nology or design that adversely affects safety; 

15 ‘‘(C) may reject a claim that a device is sub16 stantially equivalent to a predicate device if— 

17 ‘‘(i) the Secretary is in the process of re18 scinding the clearance granted under section 

19 510(k), issuing or amending an order under 

20 section 518(e) (relating to recall authority), or 

21 taking any other regulatory action because of 

22 an intrinsic flaw in technology or design that 

23 adversely affects safety, with respect to— 

24 ‘‘(I) the predicate device; or 


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1 ‘‘(II) any device in the full predicate 

2 device lineage (meaning any device for 

3 which a substantial equivalence determina4 tion was made leading to a substantial 

5 equivalence determination for the predicate 

6 device); or 

7 ‘‘(ii) the manufacturer or importer of a de8 vice described in subclause (I) or (II) of clause 

9 (i) is in the process of correcting or removing 

10 the device from the market; and 

11 ‘‘(D) may reject a claim that a device is sub12 stantially equivalent to a predicate device if the 

13 predicate device has been corrected or removed from 

14 the market and the manufacturer or importer of the 

15 predicate failed to submit notice of such correction 

16 or removal in accordance with section 519(g).’’. 

17 (c) DATABASE ON ELIGIBLE PREDICATE DEVICES.— 

18 Section 513(i) of the Federal Food, Drug, and Cosmetic 

19 Act (21 U.S.C. 360c(i)), as amended, is further amended 

20 by inserting after paragraph (3) the following: 

21 ‘‘(4)(A) The Secretary shall maintain an up-to-date 

22 database that can be used by the Secretary for purposes 

23 of determining whether devices are eligible under para24 graph (3) for use as a predicate device. 


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1 ‘‘(B) The Secretary shall determine whether a device 

2 is eligible under paragraph (3) for use as a predicate de3 vice, and shall make appropriate updates to the database 

4 under this paragraph, whenever— 

5 ‘‘(i) the Secretary issues, vacates, or amends an 

6 order for a device under section 518(e) (relating to 

7 recall authority); 

8 ‘‘(ii) the manufacturer or importer of a device 

9 reports a correction or removal of a device under 

10 subsection (g) or (h) of section 519; or 

11 ‘‘(iii) the Secretary otherwise learns of a correc12 tion or removal of a device (as such terms are used 

13 in subsections (g) and (h) of section 519). 

14 ‘‘(C) Upon making a determination required by sub15 paragraph (B), the Secretary shall include in the database 

16 under this paragraph information, to the extent such in17 formation is available to the Secretary, about the reason 

18 for the order, correction, or removal. 

19 ‘‘(D) The Secretary shall publish notice of each deter20 mination under subparagraph (B).’’. 

21 (d) REPORTS OF CORRECTIONS AND REMOVALS.— 

22 (1) IN GENERAL.—Section 519 of the Federal 

23 Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is 

24 amended by adding at the end the following: 


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1 ‘‘(h) INCLUSION OF ROOT CAUSE ANALYSIS IN RE2 PORTS OF REMOVALS AND CORRECTIONS.— 

3 ‘‘(1) REQUIREMENT.—Whenever a manufac4 turer or importer of a device is required to submit 

5 a report under subsection (g) on a corrective action 

6 or removal of the device, and whenever a manufac7 turer or importer would be so required but for sub8 mitting a report under subsection (a) on a corrective 

9 action or removal of the device, the manufacturer or 

10 importer shall submit, as an addendum to the sub11 mitted report, the root cause assessment of each de12 vice defect leading to the corrective action or re13 moval. 

14 ‘‘(2) TIMING.—An addendum required by para15 graph (1) shall be submitted to the Secretary 

16 promptly, and not later than 90 days after the cor17 rective action or removal.’’. 

18 (2) REPORTS FOR DEVICES IN SAME LINEAGE

19 AS DEVICES SUBJECT TO CORRECTIONS AND REMOV20 ALS.— 

21 (A) AUTHORITY TO ORDER REPORTS.— 

22 Section 519 of the Federal Food, Drug, and 

23 Cosmetic Act (21 U.S.C. 360i), as amended, is 

24 further amended by adding at the end the fol25 lowing: 


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1 ‘‘(i) REPORTS FOR DEVICES IN SAME LINEAGE AS

2 DEVICES SUBJECT TO CORRECTIONS AND REMOVALS.— 

3 ‘‘(1) IN GENERAL.—When a device is corrected 

4 or removed from the market because of an intrinsic 

5 flaw in technology or design that adversely affects 

6 safety— 

7 ‘‘(A) the Secretary may order the manu8 facturer or importer of each device in the same 

9 lineage which continues to be marketed to sub10 mit a report described in paragraph (2); and 

11 ‘‘(B) not later than 30 days after receipt 

12 of such an order, the manufacturer or importer 

13 of each such device shall submit the report. 

14 ‘‘(2) REPORT CONTENTS.—A report described 

15 in this paragraph shall— 

16 ‘‘(A) state whether the device for which the 

17 report is submitted shares any intrinsic flaw in 

18 technology or design associated with the device 

19 which is corrected or removed from the market; 

20 and 

21 ‘‘(B) if not, explain why the device for 

22 which the report is submitted does not share 

23 any such intrinsic flaw. 

24 ‘‘(3) DEFINITION.—In this subsection, the term 

25 ‘device in the same lineage’ refers to a device if— 


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1 ‘‘(A) a substantial equivalence determina2 tion was made for the device corrected or re3 moved from the market; and 

4 ‘‘(B) such determination leads to a sub5 stantial equivalence determination for the device 

6 involved.’’. 

7 (B) CONFORMING AMENDMENT.—Section 

8 303(f)(1)(B) of the Federal Food, Drug, and 

9 Cosmetic Act (21 U.S.C. 333(f)(1)(B)) is 

10 amended by striking ‘‘or 519(g)’’ and inserting 

11 ‘‘, 519(g), or 519(h)’’. 

12 (e) REVIEW OF PREVIOUSLY CLEARED LIFE-SUS13 TAINING, LIFE-SUPPORTING, OR IMPLANTABLE DE14 VICES.— 

15 (1) REVIEW.—The Secretary shall conduct a re16 view of all covered devices to identify any such de17 vices with respect to which a predicate device, or any 

18 device in the full device lineage, has been corrected 

19 or removed from the market pursuant to a Class I 

20 or Class II recall. 

21 (2) PRIORITY.—In conducting the review under 

22 paragraph (1), the Secretary shall prioritize— 

23 (A) the review of covered devices that pose 

24 the highest risk to patients; and 


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1 (B) the identification of covered devices 

2 that share with another device an intrinsic flaw 

3 in technology or design that— 

4 (i) adversely affects safety; and 

5 (ii) led to the correction or removal 

6 from the market of the other device. 

7 (3) REPORT.—Not later than 3 years after the 

8 date of the enactment of this Act, the Secretary 

9 shall submit a report to the Congress on the 

10 progress made by the Secretary in implementing this 

11 subsection. 

12 (4) DEFINITIONS.—In this subsection: 

13 (A) The terms ‘‘Class I’’, ‘‘Class II’’, and 

14 ‘‘recall’’ have the meanings given to such terms 

15 in section 7.3 of title 21, Code of Federal Regu16 lations (or any successor regulations). 

17 (B) The term ‘‘covered device’’ means a 

18 device (as defined in section 201 of the Federal 

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

20 321)) that— 

21 (i) is cleared under section 510(k) of 

22 such Act (21 U.S.C. 360(k)) before the ef23 fective date of the amendments made by 

24 subsections (a) through (d); 


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1 (ii) is life-sustaining, life-supporting, 

2 or implantable; and 

3 (iii) continues to be marketed. 

4 (C) The term ‘‘device in the full device lin5 eage’’ means a device for which a substantial 

6 equivalence determination was made leading to 

7 a substantial equivalence determination for a 

8 predicate device referred to in paragraph (1). 

9 (D) The term ‘‘Secretary’’ means the Sec10 retary of Health and Human Services, acting 

11 through the Commissioner of Food and Drugs. 

Æ 


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