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. 
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 ‘‘Sensible Oversight for 
Technology which Advances Regulatory Efficiency Act of 
2013’’ or the ‘‘SOFTWARE Act of 2013’’. 
SEC. 2. MEDICAL SOFTWARE. 
(a) DEFINITION OF MEDICAL SOFTWARE.—Section 
201 of the Federal Food, Drug, and Cosmetic Act (21 
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U.S.C. 321) is amended by adding at the end the fol-
lowing: 
‘‘(ss) The term ‘medical software’ means software 
that is intended for human or animal use and— 
‘‘(1)(A) is intended to be marketed to directly 
change the structure or any function of the body of 
man or other animals; or 
‘‘(B) is intended to be marketed for use by con-
sumers and makes recommendations for clinical ac-
tion that— 
‘‘(i) includes the use of a drug, device, or 
procedure to cure or treat a disease or other 
condition without requiring the involvement of a 
health care provider; and 
‘‘(ii) if followed, would change the struc-
ture or any function of the body of man or 
other animals; 
‘‘(2) is not software whose primary purpose is 
integral to the functioning of a drug or device; and 
‘‘(3) is not a component of a device.’’. 
(b) REGULATION.—Subchapter A of chapter V of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 
et seq.) is amended by adding at the end the following: 
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‘‘SEC. 524B. MEDICAL SOFTWARE. 
‘‘(a) IN GENERAL.—The provisions of this Act shall 
apply with respect to medical software to the same extent 
and in the same manner as such provisions apply with re-
spect to devices. 
‘‘(b) DELEGATION.—The Secretary shall delegate 
primary jurisdiction for regulating medical software to the 
center at the Food and Drug Administration charged with 
regulating devices.’’. 
SEC. 3. CLINICAL SOFTWARE AND HEALTH SOFTWARE. 
(a) DEFINITIONS.—Section 201 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321), as amended by 
section 2(a), is further amended by adding at the end the 
following: 
‘‘(tt)(1) The term ‘clinical software’ means clinical 
decision support software or other software (including any 
associated hardware and process dependencies) intended 
for human or animal use that— 
‘‘(A) captures, analyzes, changes, or presents 
patient or population clinical data or information 
and may recommend courses of clinical action, but 
does not directly change the structure or any func-
tion of the body of man or other animals; and 
‘‘(B) is intended to be marketed for use only by 
a health care provider in a health care setting. 
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‘‘(2) The term ‘health software’ means software (in-
cluding any associated hardware and process depend-
encies) that is not medical software or clinical software 
and— 
‘‘(A) that captures, analyzes, changes, or pre-
sents patient or population clinical data or informa-
tion; 
‘‘(B) that supports administrative or oper-
ational aspects of health care and is not used in the 
direct delivery of patient care; or 
‘‘(C) whose primary purpose is to act as a plat-
form for a secondary software, to run or act as a 
mechanism for connectivity, or to store data.’’. 
(b) PROHIBITION.—Subchapter A of chapter V of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 
et seq.), as amended by section 2(b), is further amended 
by adding at the end the following: 
‘‘SEC. 524C. CLINICAL SOFTWARE AND HEALTH SOFTWARE. 
‘‘Clinical software and health software shall not be 
subject to regulation under this Act.’’. 
(c) SENSE OF CONGRESS.—It is the sense of the Con-
gress that— 
(1) clinical software and health software (as de-
fined in section 201(tt) of the Federal Food, Drug, 
and Cosmetic Act, as added by subsection (a))— 
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(A) advance the goals of enhanced patient 
safety and continued innovation; 
(B) hold much promise to lower costs and 
improve the health of patients; and 
(C) can improve the quality and efficacy of 
health care provider services; and 
(2) the President and the Congress should work 
together to develop and enact legislation that estab-
lishes a risk-based regulatory framework for such 
clinical software and health software that reduces 
regulatory burdens, promotes patient safety, and 
fosters innovation. 
SEC. 4. EXCLUSION FROM DEFINITION OF DEVICE. 
Section 201(h) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321) is amended— 
(1) in paragraph (2), by striking ‘‘or other ani-
mals, or’’ and inserting ‘‘or other animals,’’; 
(2) in paragraph (3), by striking ‘‘and’’; and 
(3) by inserting after paragraph (3) the fol-
lowing new paragraphs: 
‘‘(4) is not medical software, or 
‘‘(5) is not clinical software or health software, 
and’’. 
Æ 
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