I 

114TH CONGRESS 

2D SESSION H. R. 4965 

To amend the Federal Food, Drug, and Cosmetic Act to enhance medical 

device communications and ensure device cleanliness. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 15, 2016 

Mr. TED LIEU of California 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 

enhance medical device communications and ensure device cleanliness. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Disclosure; and En5 couragement of Verification, Innovation, Cleaning, and 

6 Efficiency Act of 2016’’. 


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1 SEC. 2. REPORTING REQUIREMENT FOR DESIGN AND RE2 PROCESSING INSTRUCTION CHANGES. 

3 (a) ADULTERATION.—Section 501 of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amend5 ed by inserting after paragraph (j) the following: 

6 ‘‘(k) If it is a device with respect to which the manu7 facturer is in violation of the reporting requirement in sec8 tion 510(q) (relating to design and reprocessing 

9 changes).’’. 

10 (b) REQUIREMENT.—Section 510 of the Federal 

11 Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amend12 ed by adding at the end the following: 

13 ‘‘(q) REPORTING REQUIREMENT FOR DEVICE DE14 SIGN CHANGES.—Before making a change to the design 

15 of a device, or the reprocessing instructions of a device, 

16 that is marketed in interstate commerce, the manufacturer 

17 of the device shall give written notice of the change to 

18 the Food and Drug Administration.’’. 

19 SEC. 3. REPORTING REQUIREMENT FOR CERTAIN COMMU20 NICATIONS TO FOREIGN HEALTH CARE PRO21 VIDERS. 

22 (a) ADULTERATION.—Section 501 of the Federal 

23 Food, Drug, and Cosmetic Act (21 U.S.C. 351), as 

24 amended by section 2 of this Act, is further amended by 

25 inserting after paragraph (k) the following: 


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1 ‘‘(l) If it is a device with respect to which the manu2 facturer is in violation of the reporting requirement in sec3 tion 510(r) (relating to communications to foreign health 

4 care providers).’’. 

5 (b) REQUIREMENT.—Section 510 of the Federal 

6 Food, Drug, and Cosmetic Act (21 U.S.C. 360), as 

7 amended by section 2 of this Act, is further amended by 

8 adding at the end the following: 

9 ‘‘(r) REPORTING REQUIREMENT FOR CERTAIN COM10 MUNICATIONS TO FOREIGN HEALTH CARE PROVIDERS.— 

11 ‘‘(1) REQUIREMENT.—The manufacturer of a 

12 device that is marketed in interstate commerce shall 

13 give written notice to the Food and Drug Adminis14 tration of any communication described in para15 graph (2) not more than 5 calendar days after mak16 ing such communication. 

17 ‘‘(2) COMMUNICATION DESCRIBED.—A commu18 nication is described in this paragraph if the com19 munication— 

20 ‘‘(A) is made by the manufacturer of the 

21 device or an affiliate of the manufacturer; 

22 ‘‘(B) relates to a change to the design of 

23 the device, a change to the recommended re24 processing protocols, if any, for the device, or a 

25 safety concern about the device; and 


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1 ‘‘(C) is widely disseminated (including on a 

2 voluntary basis) to health care providers in a 

3 foreign country. 

4 ‘‘(3) AFFILIATE.—In this subsection, the term 

5 ‘affiliate’ means a business entity that has a rela6 tionship with a second business entity if, directly or 

7 indirectly— 

8 ‘‘(A) one business entity controls, or has 

9 the power to control, the other business entity; 

10 or 

11 ‘‘(B) a third party controls, or has the 

12 power to control, both of the business entities.’’. 

13 SEC. 4. RAPID ASSESSMENT TESTS INTENDED TO ENSURE 

14 PROPER REPROCESSING. 

15 (a) INCLUSION IN DEVICE DEFINITION.—Section 

16 201 of the Federal Food, Drug, and Cosmetic Act (21 

17 U.S.C. 321) is amended— 

18 (1) in paragraph (h)— 

19 (A) in subparagraph (2), by striking ‘‘or’’ 

20 at the end; 

21 (B) in subparagraph (3), by striking ‘‘and’’ 

22 at the end and inserting ‘‘or’’; and 

23 (C) by inserting after subparagraph (3) 

24 the following: 


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1 ‘‘(4) a rapid assessment test intended to ensure 

2 the proper reprocessing of a reusable device (as de3 fined in paragraph (ss)), and’’; and 

4 (2) by adding at the end the following: 

5 ‘‘(ss) The term ‘reusable device’ means a device 

6 that— 

7 ‘‘(1) is intended to be used more than one time; 

8 and 

9 ‘‘(2) must be sanitized (whether through clean10 ing, disinfection, or sterilization) to ensure that the 

11 device is safe and effective for such intended use.’’. 

12 (b) INSTRUCTIONS FOR USE AND VALIDATION

13 DATA.—Section 510 of the Federal Food, Drug, and Cos14 metic Act (21 U.S.C. 360), as amended by sections 2 and 

15 3 of this Act, is further amended by adding at the end 

16 the following: 

17 ‘‘(s) INSTRUCTIONS FOR USE AND VALIDATION

18 DATA.— 

19 ‘‘(1) INITIAL LIST.—Not later than 1 year after 

20 the date of enactment of this subsection, the Sec21 retary shall by regulation develop and publish a list 

22 of types of rapid assessment tests described in sec23 tion 201(h)(4) for which reports under subsection 

24 (k) must include— 


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1 ‘‘(A) instructions for use that have been 

2 validated in a manner specified by the Sec3 retary; and 

4 ‘‘(B) validation data, of the types specified 

5 by the Secretary. 

6 ‘‘(2) UPDATES.—The Secretary shall by regula7 tion periodically update the list required by para8 graph (1). 

9 ‘‘(3) ENFORCEMENT.—Beginning on the date 

10 of publication of the initial list under paragraph (1), 

11 the Secretary shall not accept any notification under 

12 subsection (k) for clearance of a type of rapid as13 sessment test that is included on such list unless 

14 such notification includes instructions for use and 

15 validation data in accordance with paragraph (1).’’. 

Æ 


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