I 
116TH CONGRESS 
2D SESSION 
H. R. 6062 
To amend certain provisions in the Federal Food, Drug, and Cosmetic Act 
relating to the discontinuance or interruption in the production of life- 
saving drugs so as to apply such provisions with respect to life-saving 
devices, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 3, 2020 
Mr. SCHNEIDER (for himself, Mr. HICE of Georgia, and Ms. SCHAKOWSKY) 
introduced the following bill; which was referred to the Committee on En-
ergy and Commerce 
A BILL 
To amend certain provisions in the Federal Food, Drug, 
and Cosmetic Act relating to the discontinuance or inter-
ruption in the production of life-saving drugs so as to 
apply such provisions with respect to life-saving devices, 
and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. DISCONTINUANCE OR INTERRUPTION IN THE 
PRODUCTION OF LIFE-SAVING DEVICES. 
(a) NOTIFICATION REQUIREMENT.—Section 506C of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356c) is amended— 
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(1) in the section heading, by striking ‘‘LIFE- 
SAVING
DRUGS’’ and inserting ‘‘LIFE-SAVING 
DRUGS AND DEVICES’’; 
(2) in the matter preceding paragraph (1) in 
subsection (a), by striking ‘‘a drug’’ and inserting ‘‘a 
drug or device’’; 
(3) in subsection (a)(1)(C), by striking ‘‘such 
drug’’ and inserting ‘‘such drug or device’’; 
(4) in the matter following paragraph (2) in 
subsection (a), by striking ‘‘the drug’’ each place it 
appears and inserting ‘‘the drug or device’’; 
(5) in subsection (c), by striking ‘‘the drugs’’ 
and inserting ‘‘the drugs or devices’’; 
(6) in the matter before paragraph (1) in sub-
section (g), by striking ‘‘a drug shortage of a drug 
described in subsection (a)’’ and inserting ‘‘a drug 
or device shortage of a drug or device described in 
subsection (a)’’; 
(7) in subsection (g)(1), by striking ‘‘or a sup-
plement to such an application submitted under sec-
tion 505(j), that could help mitigate or prevent such 
shortage’’ and inserting ‘‘a supplement to such an 
application submitted under section 505(j), or a sub-
mission for clearance of a device under section 
510(k), classification of a device under section 
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513(f)(2), or approval of a device under section 515, 
that could help mitigate or prevent such shortage’’; 
(8) in subsection (g)(2), by striking ‘‘such drug 
shortage’’ and inserting ‘‘such drug or device short-
age’’; 
(9) in subsection (h), by amending paragraph 
(2) to read as follows: 
‘‘(2) the term ‘drug or device shortage’ or 
‘shortage’, with respect to a drug or device, means 
a period of time when the demand or projected de-
mand for the drug or device within the United 
States exceeds the supply of the drug or device; 
and’’; and 
(10) in subsection (h)(3)(A), by striking ‘‘a 
drug’’ and inserting ‘‘a drug or device’’. 
(b) ANNUAL REPORTING ON SHORTAGES.—Section 
506C–1 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 356c–1) is amended— 
(1) in the section heading, by striking ‘‘DRUG 
SHORTAGES’’ and inserting ‘‘DRUG AND DEVICE 
SHORTAGES’’; 
(2) in subsections (a) and (b), by striking 
‘‘drug shortages’’ each place it appears and inserting 
‘‘drug and device shortages’’; 
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SEC. 3. IMPORTATION OF DEVICES IN SHORTAGE. 
Section 801(d) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 381(d)) is amended— 
(1) in paragraph (1), by adding at the end the 
following subparagraph: 
‘‘(C) Except as authorized by the Secretary in the 
case of a device that appears on the drug and device short-
age list under section 506E, no device may be imported 
into the United States for commercial use if such device 
is manufactured outside the United States, unless the 
manufacturer has authorized the device to be marketed 
in the United States and has caused the device to be la-
beled to be marketed in the United States.’’; and 
(2) in paragraph (2), by striking ‘‘drug’’ each 
place it appears and inserting ‘‘drug or device’’. 
Æ 
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