I 
115TH CONGRESS 
1ST SESSION H. R. 2144 
To amend the Federal Food, Drug, and Cosmetic Act to provide for the 
appropriate, risk-based classification of device accessories based on their 
intended uses. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 25, 2017 
Mrs. MIMI WALTERS of California (for herself and Ms. KUSTER of New 
Hampshire) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
provide for the appropriate, risk-based classification of 
device accessories based on their intended uses. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Risk-Based Classification of Accessories Act of 2017’’. 
(b) FINDINGS.—The Congress finds that there is a 
need for an appropriate process for the timely classifica-
tion of device accessories, in accordance with the 21st Cen-
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tury Cures Act (Public Law 114–255), such that acces-
sories are classified in accordance with their intended uses. 
SEC. 2. RISK-BASED CLASSIFICATION OF ACCESSORIES. 
Section 513(b)(9) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360c(b)(9)) is amended to read 
as follows: 
‘‘(9)(A) Subject to the succeeding subpara-
graphs of this paragraph, the Secretary shall classify 
an accessory under this section based on the in-
tended use of the accessory, notwithstanding the 
classification of any other device with which such ac-
cessory is intended to be used. 
‘‘(B) In the case of an accessory that, as of De-
cember 13, 2016, has been classified in accordance 
with subparagraph (A), such classification shall con-
tinue to apply to such accessory. 
‘‘(C)(i) In the case of an accessory that has 
been cleared under section 510(k) or approved under 
section 515 based on the classification of another de-
vice with which such accessory is intended to be 
used, and the Secretary has established a classifica-
tion for such accessory in accordance with subpara-
graph (A), the manufacturer of such accessory may, 
in lieu of submitting a request for classification of 
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‘‘(ii) The Secretary shall respond to a submis-
sion made under clause (i) not later than 60 days 
after receiving such submission by approving or de-
nying the recommended classification of the acces-
sory. The Secretary shall provide an opportunity for 
a manufacturer to meet with appropriate personnel 
of the Food and Drug Administration to discuss the 
appropriate classification of such accessory prior to 
making a written submission. 
‘‘(F) Nothing in this paragraph may be con-
strued as precluding a manufacturer of an accessory 
from using the classification process described in 
section subsection (f)(2) to obtain classification of 
such accessory.’’. 
SEC. 3. EFFECTIVE DATE. 
The amendment made by section 2 shall take effect 
on the date that is 60 days after the date of the enactment 
of this Act. 
Æ 
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