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. 

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 ‘‘Humanitarian Device 

5 Reform Act of 2011’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds as follows: 

8 (1) The humanitarian device exemption (HDE) 

9 approval pathway, administered by the Food and 


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1 Drug Administration (FDA), is intended to accel2 erate the availability of innovative medical tech3 nologies to treat rare diseases or conditions, by al4 lowing sponsors of such devices to demonstrate the 

5 safety and probable benefit to patients of medical 

6 devices to treat or diagnose a disease or condition 

7 that affects fewer than 4,000 patients in the United 

8 States per year. 

9 (2) Since the inception of the humanitarian de10 vice exemption, only 53 medical devices have been 

11 granted an HDE in the United States. From 2005 

12 through 2009, only 20 HDE applications were filed, 

13 and a mere 11 were approved by the FDA. 

14 (3) In sharp contrast, under the Orphan Drug 

15 Act (Public Law 97–414) more than 2,150 drugs 

16 have been designated by the Secretary of Health and 

17 Human Services as being for rare diseases or condi18 tions and 358 such drugs have been approved for 

19 use in the United States. 

20 (4) In 2010, the FDA conceded the scope of the 

21 remaining unmet medical needs for American pa22 tients, testifying to Congress that ‘‘there are still an 

23 estimated 20 million Americans suffering from rare 

24 diseases for which there are no approved therapies 

25 available’’. 


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1 (5) In 2010, the former Director of the FDA’s 

2 Center for Devices and Radiological Health (CDRH) 

3 concluded, ‘‘[t]he potential for HDEs to foster inno4 vation has not been reached because of the regu5 latory burdens of the program’’. 

6 (6) In 2007, the American Academy of Pediat7 rics testified to Congress, ‘‘The profit restriction on 

8 HDE-approved devices limits the effectiveness of the 

9 provision by forcing device manufacturers to only re10 cover their research and development costs’’. 

11 (7) Targeted reforms are consequently needed 

12 to strengthen and enhance the HUD/HDE pathway. 

13 SEC. 3. REPEAL OF PROFIT PROHIBITION. 

14 Section 520(m) of the Federal Food, Drug and Cos15 metic Act (21 U.S.C. 360j(m)) is amended— 

16 (1) by striking paragraphs (3), (6), (7), and 

17 (8); and 

18 (2) in paragraph (5), by striking ‘‘, if the Sec19 retary has reason to believe that the requirements of 

20 paragraph (6) are no longer met,’’. 

21 SEC. 4. CLARIFICATION OF REFERENCES TO RARE DIS22 EASES OR CONDITIONS. 

23 Paragraphs (1) and (2)(A) of section 520(m) of the 

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


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1 360j(m)) are amended by inserting ‘‘per year’’ after 

2 ‘‘4,000 individuals in the United States’’. 

Æ 


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