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 de-
vice cleanliness. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Disclosure; and En-
couragement of Verification, Innovation, Cleaning, and 
Efficiency Act of 2016’’. 
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SEC. 2. REPORTING REQUIREMENT FOR DESIGN AND RE-
PROCESSING INSTRUCTION CHANGES. 
(a) ADULTERATION.—Section 501 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amend-
ed by inserting after paragraph (j) the following: 
‘‘(k) If it is a device with respect to which the manu-
facturer is in violation of the reporting requirement in sec-
tion 510(q) (relating to design and reprocessing 
changes).’’. 
(b) REQUIREMENT.—Section 510 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amend-
ed by adding at the end the following: 
‘‘(q) REPORTING REQUIREMENT FOR DEVICE DE-
SIGN CHANGES.—Before making a change to the design 
of a device, or the reprocessing instructions of a device, 
that is marketed in interstate commerce, the manufacturer 
of the device shall give written notice of the change to 
the Food and Drug Administration.’’. 
SEC. 3. REPORTING REQUIREMENT FOR CERTAIN COMMU-
NICATIONS TO FOREIGN HEALTH CARE PRO-
VIDERS. 
(a) ADULTERATION.—Section 501 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351), as 
amended by section 2 of this Act, is further amended by 
inserting after paragraph (k) the following: 
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‘‘(l) If it is a device with respect to which the manu-
facturer is in violation of the reporting requirement in sec-
tion 510(r) (relating to communications to foreign health 
care providers).’’. 
(b) REQUIREMENT.—Section 510 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360), as 
amended by section 2 of this Act, is further amended by 
adding at the end the following: 
‘‘(r) REPORTING REQUIREMENT FOR CERTAIN COM-
MUNICATIONS TO FOREIGN HEALTH CARE PROVIDERS.— 
‘‘(1) REQUIREMENT.—The manufacturer of a 
device that is marketed in interstate commerce shall 
give written notice to the Food and Drug Adminis-
tration of any communication described in para-
graph (2) not more than 5 calendar days after mak-
ing such communication. 
‘‘(2) COMMUNICATION DESCRIBED.—A commu-
nication is described in this paragraph if the com-
munication— 
‘‘(A) is made by the manufacturer of the 
device or an affiliate of the manufacturer; 
‘‘(B) relates to a change to the design of 
the device, a change to the recommended re-
processing protocols, if any, for the device, or a 
safety concern about the device; and 
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