I 
112TH CONGRESS 
1ST SESSION H. R. 3211 
To amend the Federal Food, Drug, and Cosmetic Act to improve 
humanitarian device regulation. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 14, 2011 
Mr. BASS of New Hampshire (for himself, Mr. ROGERS of Michigan, Mr. 
LANCE, Mrs. BLACKBURN, Mr. GUTHRIE, Mr. PAULSEN, Mr. LATTA, and 
Mr. SHIMKUS) 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 
improve humanitarian device regulation. 
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 ‘‘Humanitarian Device 
Reform Act of 2011’’. 
SEC. 2. FINDINGS. 
Congress finds as follows: 
(1) The humanitarian device exemption (HDE) 
approval pathway, administered by the Food and 
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Drug Administration (FDA), is intended to accel-
erate the availability of innovative medical tech-
nologies to treat rare diseases or conditions, by al-
lowing sponsors of such devices to demonstrate the 
safety and probable benefit to patients of medical 
devices to treat or diagnose a disease or condition 
that affects fewer than 4,000 patients in the United 
States per year. 
(2) Since the inception of the humanitarian de-
vice exemption, only 53 medical devices have been 
granted an HDE in the United States. From 2005 
through 2009, only 20 HDE applications were filed, 
and a mere 11 were approved by the FDA. 
(3) In sharp contrast, under the Orphan Drug 
Act (Public Law 97–414) more than 2,150 drugs 
have been designated by the Secretary of Health and 
Human Services as being for rare diseases or condi-
tions and 358 such drugs have been approved for 
use in the United States. 
(4) In 2010, the FDA conceded the scope of the 
remaining unmet medical needs for American pa-
tients, testifying to Congress that ‘‘there are still an 
estimated 20 million Americans suffering from rare 
diseases for which there are no approved therapies 
available’’. 
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(5) In 2010, the former Director of the FDA’s 
Center for Devices and Radiological Health (CDRH) 
concluded, ‘‘[t]he potential for HDEs to foster inno-
vation has not been reached because of the regu-
latory burdens of the program’’. 
(6) In 2007, the American Academy of Pediat-
rics testified to Congress, ‘‘The profit restriction on 
HDE-approved devices limits the effectiveness of the 
provision by forcing device manufacturers to only re-
cover their research and development costs’’. 
(7) Targeted reforms are consequently needed 
to strengthen and enhance the HUD/HDE pathway. 
SEC. 3. REPEAL OF PROFIT PROHIBITION. 
Section 520(m) of the Federal Food, Drug and Cos-
metic Act (21 U.S.C. 360j(m)) is amended— 
(1) by striking paragraphs (3), (6), (7), and 
(8); and 
(2) in paragraph (5), by striking ‘‘, if the Sec-
retary has reason to believe that the requirements of 
paragraph (6) are no longer met,’’. 
SEC. 4. CLARIFICATION OF REFERENCES TO RARE DIS-
EASES OR CONDITIONS. 
Paragraphs (1) and (2)(A) of section 520(m) of the 
Federal Food, Drug and Cosmetic Act (21 U.S.C. 
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360j(m)) are amended by inserting ‘‘per year’’ after 
‘‘4,000 individuals in the United States’’. 
Æ 
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