II 

115TH CONGRESS 

1ST SESSION S. 1070 

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

appropriate, risk-based classification of device accessories based on intended use. 

IN THE SENATE OF THE UNITED STATES 

MAY 8, 2017 

Mr. ROBERTS (for himself, Mr. DONNELLY, and Mr. BURR) introduced the 

following bill; which was read twice and referred to the Committee on 

Health, Education, Labor, and Pensions 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

provide for the appropriate, risk-based classification of 

device accessories based on intended use. 

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 ‘‘Realizing Intended 

5 Safety for Certain Accessories Act of 2017’’. 

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

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

8 Cosmetic Act (21 U.S.C. 360c(b)(9)) is amended— 

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1 (1) by striking ‘‘(9) The Secretary’’ and insert2 ing ‘‘(9)(A) The Secretary’’; and 

3 (2) by adding at the end the following: 

4 ‘‘(B) The classification of any accessory classified 

5 prior to December 13, 2016, based on the intended use 

6 or uses of such accessory, shall continue to apply, notwith7 standing the classification of any other device with which 

8 such accessory is intended to be used. 

9 ‘‘(C)(i) If— 

10 ‘‘(I) an accessory has been cleared or approved 

11 based on the classification of another device with 

12 which such accessory is intended to be used; and 

13 ‘‘(II) the Secretary has established a classifica14 tion for such accessory based on the intended use or 

15 uses of the accessory, in accordance with subpara16 graph (A), 

17 the manufacturer of such accessory may identify the clas18 sification described in subclause (II) in a written notifica19 tion to the Secretary. 

20 ‘‘(ii) Unless the Secretary notifies a manufacturer 

21 within 30 calendar days of receipt of a written notification 

22 described in clause (i) that the Secretary does not agree 

23 that the classification identified in such written notifica24 tion is appropriate for the accessory, the accessory shall 

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1 be automatically reclassified in accordance with the classi2 fication identified in such written notification. 

3 ‘‘(iii) A written notification that the Secretary dis4 agrees with the classification identified in a written notifi5 cation described in clause (ii) shall include a detailed de6 scription and justification for the determination to dis7 agree. 

8 ‘‘(D)(i) A manufacturer of an accessory that has been 

9 previously classified by the Secretary based on the in10 tended use of another device with which the accessory is 

11 intended to be used, through an application for such other 

12 device under section 515(c), a report under section 510(k), 

13 or a petition for classification under section 513(f)(2), and 

14 that has not been classified by the Secretary based on the 

15 intended use or uses of the accessory as described in sub16 paragraph (A) or (C), may submit to the Secretary a writ17 ten recommendation for the appropriate classification of 

18 such accessory based on its intended use or uses. Such 

19 submission shall include such information to support the 

20 recommendation as the Secretary may require. 

21 ‘‘(ii) The Secretary shall respond to a submission 

22 under clause (i) within 60 calendar days by approving or 

23 denying the recommended classification of the accessory. 

24 If the Secretary does not agree with the recommendation 

25 for classification submitted by the sponsor, the response 

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1 shall include a detailed description and justification for 

2 such determination to disagree. The Secretary shall pro3 vide an opportunity for a manufacturer to meet with ap4 propriate personnel to discuss appropriate classification of 

5 such accessory prior to submitting a written recommenda6 tion. 

7 ‘‘(E) At the time a sponsor submits an application 

8 for premarket approval for a class III device pursuant to 

9 section 515(c), the sponsor of such application may in10 clude a recommendation and supporting information for 

11 the proper classification of such accessory pursuant to 

12 subparagraph (A). If such device is intended to be used 

13 with an accessory that has not been classified by the Sec14 retary based on its intended use or uses as described in 

15 subparagraph (A) or (C), the Secretary shall— 

16 ‘‘(i) approve or deny the application pursuant 

17 to section 515(d); and 

18 ‘‘(ii) approve or deny the classification of the 

19 accessory proposed in the application submitted 

20 under this clause. 

21 ‘‘(F) A manufacturer may at any time use the classi22 fication process described in section 513(f)(2) to obtain 

23 classification of an accessory.’’. 

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