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 Committee 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. 

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 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Risk-Based Classification of Accessories Act of 2017’’. 

6 (b) FINDINGS.—The Congress finds that there is a 

7 need for an appropriate process for the timely classifica8 tion of device accessories, in accordance with the 21st CenVerDate Sep 11 2014 00:13 Apr 27, 2017 Jkt 069200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2144.IH H2144

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1 tury Cures Act (Public Law 114–255), such that acces2 sories are classified in accordance with their intended uses. 

3 SEC. 2. RISK-BASED CLASSIFICATION OF ACCESSORIES. 

4 Section 513(b)(9) of the Federal Food, Drug, and 

5 Cosmetic Act (21 U.S.C. 360c(b)(9)) is amended to read 

6 as follows: 

7 ‘‘(9)(A) Subject to the succeeding subpara8 graphs of this paragraph, the Secretary shall classify 

9 an accessory under this section based on the in10 tended use of the accessory, notwithstanding the 

11 classification of any other device with which such ac12 cessory is intended to be used. 

13 ‘‘(B) In the case of an accessory that, as of De14 cember 13, 2016, has been classified in accordance 

15 with subparagraph (A), such classification shall con16 tinue to apply to such accessory. 

17 ‘‘(C)(i) In the case of an accessory that has 

18 been cleared under section 510(k) or approved under 

19 section 515 based on the classification of another de20 vice with which such accessory is intended to be 

21 used, and the Secretary has established a classifica22 tion for such accessory in accordance with subpara23 graph (A), the manufacturer of such accessory may, 

24 in lieu of submitting a request for classification of 


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1 such accessory, submit a written notification to the 

2 Secretary identifying such classification. 

3 ‘‘(ii) Unless the Secretary, not later than 30 

4 days after receiving a notification under clause (i), 

5 informs the manufacturer involved that the Sec6 retary does not agree that the classification identi7 fied in such notification is appropriate for the acces8 sory, the accessory shall be automatically reclassified 

9 in the classification so identified. 

10 ‘‘(D)(i) In the case of a device intended to be 

11 used with an accessory that has not been classified 

12 by the Secretary in accordance with subparagraph 

13 (A), the person filing an application for premarket 

14 approval of such device under section 515 or a re15 port under section 510(k) for clearance of such de16 vice, may, at the time such application or report (as 

17 applicable) is filed, include with such application— 

18 ‘‘(I) a recommendation for the proper clas19 sification of the accessory pursuant to such sub20 paragraph; and 

21 ‘‘(II) such appropriate information to sup22 port the recommendation as may be specified by 

23 the Secretary. 

24 ‘‘(ii) The Secretary’s response under section 

25 515(d) or section 510(n) (as applicable) to an appliVerDate Sep 11 2014 00:13 Apr 27, 2017 Jkt 069200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2144.IH H2144

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1 cation or report described in clause (i) shall also 

2 contain the Secretary’s approval or denial of the pro3 posed classification of the accessory involved. 

4 ‘‘(iii) The Secretary’s evaluation of an accessory 

5 under clause (i) shall constitute an order estab6 lishing a new classification for such accessory for the 

7 specified intended use or uses of such accessory and 

8 for any accessory with the same intended use or uses 

9 as such accessory. 

10 ‘‘(E)(i) A manufacturer of an accessory that 

11 has been previously classified by the Secretary based 

12 on the intended use of another device with which 

13 such accessory is intended to be used, through the 

14 approval of such other device under section 515(c), 

15 the clearance of such device under section 510(k), or 

16 the submission of a petition for classification under 

17 section 513(f)(2), and that has not been classified by 

18 the Secretary in accordance with subparagraph (A), 

19 may make a written submission to the Secretary 

20 containing a recommendation for the appropriate 

21 classification of the accessory based on the intended 

22 use or uses of the accessory. Such submission may 

23 include appropriate information to support the rec24 ommendation as may be specified by the Secretary. 


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1 ‘‘(ii) The Secretary shall respond to a submis2 sion made under clause (i) not later than 60 days 

3 after receiving such submission by approving or de4 nying the recommended classification of the acces5 sory. The Secretary shall provide an opportunity for 

6 a manufacturer to meet with appropriate personnel 

7 of the Food and Drug Administration to discuss the 

8 appropriate classification of such accessory prior to 

9 making a written submission. 

10 ‘‘(F) Nothing in this paragraph may be con11 strued as precluding a manufacturer of an accessory 

12 from using the classification process described in 

13 section subsection (f)(2) to obtain classification of 

14 such accessory.’’. 

15 SEC. 3. EFFECTIVE DATE. 

16 The amendment made by section 2 shall take effect 

17 on the date that is 60 days after the date of the enactment 

18 of this Act. 

Æ 


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