I 

113TH CONGRESS 

1ST SESSION H. R. 3303 

To amend the Federal Food, Drug, and Cosmetic Act to provide for regulating 

medical software, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 22, 2013 

Mrs. BLACKBURN (for herself, Mr. GENE GREEN of Texas, Mr. WALDEN, Ms. 

DEGETTE, Mr. BUTTERFIELD, and Mr. GINGREY of Georgia) 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 

provide for regulating medical software, and for other 

purposes. 

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 ‘‘Sensible Oversight for 

5 Technology which Advances Regulatory Efficiency Act of 

6 2013’’ or the ‘‘SOFTWARE Act of 2013’’. 

7 SEC. 2. MEDICAL SOFTWARE. 

8 (a) DEFINITION OF MEDICAL SOFTWARE.—Section 

9 201 of the Federal Food, Drug, and Cosmetic Act (21 


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1 U.S.C. 321) is amended by adding at the end the fol2 lowing: 

3 ‘‘(ss) The term ‘medical software’ means software 

4 that is intended for human or animal use and— 

5 ‘‘(1)(A) is intended to be marketed to directly 

6 change the structure or any function of the body of 

7 man or other animals; or 

8 ‘‘(B) is intended to be marketed for use by con9 sumers and makes recommendations for clinical ac10 tion that— 

11 ‘‘(i) includes the use of a drug, device, or 

12 procedure to cure or treat a disease or other 

13 condition without requiring the involvement of a 

14 health care provider; and 

15 ‘‘(ii) if followed, would change the struc16 ture or any function of the body of man or 

17 other animals; 

18 ‘‘(2) is not software whose primary purpose is 

19 integral to the functioning of a drug or device; and 

20 ‘‘(3) is not a component of a device.’’. 

21 (b) REGULATION.—Subchapter A of chapter V of the 

22 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 

23 et seq.) is amended by adding at the end the following: 


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1 ‘‘SEC. 524B. MEDICAL SOFTWARE. 

2 ‘‘(a) IN GENERAL.—The provisions of this Act shall 

3 apply with respect to medical software to the same extent 

4 and in the same manner as such provisions apply with re5 spect to devices. 

6 ‘‘(b) DELEGATION.—The Secretary shall delegate 

7 primary jurisdiction for regulating medical software to the 

8 center at the Food and Drug Administration charged with 

9 regulating devices.’’. 

10 SEC. 3. CLINICAL SOFTWARE AND HEALTH SOFTWARE. 

11 (a) DEFINITIONS.—Section 201 of the Federal Food, 

12 Drug, and Cosmetic Act (21 U.S.C. 321), as amended by 

13 section 2(a), is further amended by adding at the end the 

14 following: 

15 ‘‘(tt)(1) The term ‘clinical software’ means clinical 

16 decision support software or other software (including any 

17 associated hardware and process dependencies) intended 

18 for human or animal use that— 

19 ‘‘(A) captures, analyzes, changes, or presents 

20 patient or population clinical data or information 

21 and may recommend courses of clinical action, but 

22 does not directly change the structure or any func23 tion of the body of man or other animals; and 

24 ‘‘(B) is intended to be marketed for use only by 

25 a health care provider in a health care setting. 


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1 ‘‘(2) The term ‘health software’ means software (in2 cluding any associated hardware and process depend3 encies) that is not medical software or clinical software 

4 and— 

5 ‘‘(A) that captures, analyzes, changes, or pre6 sents patient or population clinical data or informa7 tion; 

8 ‘‘(B) that supports administrative or oper9 ational aspects of health care and is not used in the 

10 direct delivery of patient care; or 

11 ‘‘(C) whose primary purpose is to act as a plat12 form for a secondary software, to run or act as a 

13 mechanism for connectivity, or to store data.’’. 

14 (b) PROHIBITION.—Subchapter A of chapter V of the 

15 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 

16 et seq.), as amended by section 2(b), is further amended 

17 by adding at the end the following: 

18 ‘‘SEC. 524C. CLINICAL SOFTWARE AND HEALTH SOFTWARE. 

19 ‘‘Clinical software and health software shall not be 

20 subject to regulation under this Act.’’. 

21 (c) SENSE OF CONGRESS.—It is the sense of the Con22 gress that— 

23 (1) clinical software and health software (as de24 fined in section 201(tt) of the Federal Food, Drug, 

25 and Cosmetic Act, as added by subsection (a))— 


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1 (A) advance the goals of enhanced patient 

2 safety and continued innovation; 

3 (B) hold much promise to lower costs and 

4 improve the health of patients; and 

5 (C) can improve the quality and efficacy of 

6 health care provider services; and 

7 (2) the President and the Congress should work 

8 together to develop and enact legislation that estab9 lishes a risk-based regulatory framework for such 

10 clinical software and health software that reduces 

11 regulatory burdens, promotes patient safety, and 

12 fosters innovation. 

13 SEC. 4. EXCLUSION FROM DEFINITION OF DEVICE. 

14 Section 201(h) of the Federal Food, Drug, and Cos15 metic Act (21 U.S.C. 321) is amended— 

16 (1) in paragraph (2), by striking ‘‘or other ani17 mals, or’’ and inserting ‘‘or other animals,’’; 

18 (2) in paragraph (3), by striking ‘‘and’’; and 

19 (3) by inserting after paragraph (3) the fol20 lowing new paragraphs: 

21 ‘‘(4) is not medical software, or 

22 ‘‘(5) is not clinical software or health software, 

23 and’’. 

Æ 


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