II 

115TH CONGRESS 

1ST SESSION S. 1093 

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

medical device application procedures. 

IN THE SENATE OF THE UNITED STATES 

MAY 10, 2017 

Mr. FRANKEN (for himself and Mr. ENZI) 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 

improve pediatric medical device application procedures. 

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 ‘‘Pediatric Device Devel5 opment Act’’. 

6 SEC. 2. PEDIATRIC USES OF DEVICES. 

7 Section 515A of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 360e–1) is amended— 

9 (1) in subsection (a)(3)— 


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1 (A) by redesignating subparagraphs (B) 

2 through (D) as subparagraphs (D) through (F), 

3 respectively; 

4 (B) by inserting after subparagraph (A) 

5 the following: 

6 ‘‘(B) an assessment of pediatric device la7 beling needs, based on a review of real world 

8 evidence on the off-label use of medical devices 

9 in children, drawn from data available to the 

10 Food and Drug Administration; 

11 ‘‘(C) the number of devices that receive a 

12 humanitarian use exemption under section 

13 520(m);’’; 

14 (C) in subparagraph (E) (as so redesig15 nated), by striking ‘‘; and’’ and inserting ‘‘;’’; 

16 (D) in subparagraph (F) (as so redesig17 nated), by striking ‘‘(B), and (C).’’ and insert18 ing ‘‘(C), (D), and (E); and’’; and 

19 (E) by adding at the end the following: 

20 ‘‘(G) the number of devices for which ex21 trapolation was used to support the approval of 

22 pediatric labeling of such devices. 

23 For the items described in this paragraph, such re24 port shall disaggregate the number of devices by pe25 diatric subpopulation.’’; 


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1 (2) by redesignating subsection (c) as sub2 section (d); and 

3 (3) by inserting after subsection (b), the fol4 lowing: 

5 ‘‘(c) PEDIATRIC DEVICE INNOVATION.— 

6 ‘‘(1) IN GENERAL.—The Secretary shall, not 

7 later than 1 year after the date of enactment of the 

8 Pediatric Device Development Act, establish within 

9 the Center for Devices and Radiological Health a 

10 structure to— 

11 ‘‘(A) provide assistance to device manufac12 turers, in coordination with the relevant review 

13 committees, as appropriate, that would result in 

14 the development, approval, and labeling of med15 ical devices for children; 

16 ‘‘(B) oversee an internal pediatrics team 

17 that— 

18 ‘‘(i) is comprised of— 

19 ‘‘(I) employees of the Food and 

20 Drug Administration with expertise in 

21 pediatrics and appropriate expertise 

22 pertaining to the relevant devices 

23 under review; and 

24 ‘‘(II) other individuals designated 

25 by the Secretary; and 


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1 ‘‘(ii) provides expertise and consulta2 tion on— 

3 ‘‘(I) the application of subsection 

4 (b), section 520(m), section 510(k), 

5 and section 522 of this Act and sec6 tion 402 of the Public Health Service 

7 Act to pediatric devices; and 

8 ‘‘(II) pediatrics, as it pertains to 

9 reviewing devices, to all applicable di10 visions within the Center for Devices 

11 and Radiological Health; 

12 ‘‘(C) coordinate pediatric activities within 

13 the Center for Devices and Radiological Health; 

14 and 

15 ‘‘(D) collaborate with other programs, of16 fices, and centers of the Food and Drug Admin17 istration, including the consortia program au18 thorized under section 305 of the Pediatric 

19 Medical Device Safety and Improvement Act of 

20 2007. 

21 ‘‘(2) STAFF.—Such structure shall include a 

22 chief pediatric medical officer and other appropriate 

23 individuals as the Secretary determines necessary.’’. 


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1 SEC. 3. HUMANITARIAN DEVICE EXEMPTION. 

2 Section 520(m) of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 360j(m)) is amended— 

4 (1) in paragraph (4)— 

5 (A) by striking ‘‘an institutional review 

6 committee’’ each place such term appears and 

7 inserting ‘‘an institutional review board or an 

8 appropriate local committee’’; and 

9 (B) by striking ‘‘the institutional review 

10 committee’’ and inserting ‘‘the institutional re11 view board or the appropriate local committee’’; 

12 and 

13 (2) in paragraph (6)(A)(iv), by striking ‘‘2017’’ 

14 and inserting ‘‘2022’’. 

15 SEC. 4. DEMONSTRATION GRANTS FOR IMPROVING PEDI16 ATRIC AVAILABILITY. 

17 Section 305 of the Pediatric Medical Device Safety 

18 and Improvement Act of 2007 (Public Law 110–85; 42 

19 U.S.C. 282 note) is amended— 

20 (1) in subsection (c)— 

21 (A) in paragraph (4), by striking ‘‘and’’ at 

22 the end; 

23 (B) in paragraph (5), by striking the pe24 riod and inserting ‘‘; and’’; and 

25 (C) by adding at the end the following: 


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1 ‘‘(6) providing regulatory consultation to device 

2 sponsors in support of the submission of an applica3 tion for a pediatric device, where appropriate.’’; and 

4 (2) in subsection (e), by striking ‘‘2017’’ and 

5 inserting ‘‘2022’’. 

6 SEC. 5. MEETING ON PEDIATRIC DEVICE DEVELOPMENT. 

7 (a) IN GENERAL.—Not later than 1 year after the 

8 date of enactment of this Act, the Secretary of Health and 

9 Human Services shall convene a public meeting regarding 

10 opportunities and barriers to the development, approval, 

11 and labeling of pediatric medical devices. Such meeting 

12 shall include representatives from the medical device in13 dustry, academia, recipients of funding under section 305 

14 of the Pediatric Medical Device Safety and Improvement 

15 Act of 2007 (Public Law 110–85; 42 U.S.C. 282 note), 

16 medical provider organizations, and organizations rep17 resenting patients and consumers. 

18 (b) TOPICS.—The meeting described in subsection (a) 

19 shall include consideration of ways to— 

20 (1) improve research infrastructure and re21 search networks to facilitate the conduct of clinical 

22 studies of devices for children that would result in 

23 the approval and labeling of medical devices for chil24 dren; 


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1 (2) appropriately use extrapolation under sec2 tion 515A(b) of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 360e–1(b)); 

4 (3) enhance the appropriate use of postmarket 

5 registries and data to increase pediatric medical de6 vice labeling; 

7 (4) increase Food and Drug Administration as8 sistance to medical device manufacturers in devel9 oping devices for children that are approved and la10 beled for their use; and 

11 (5) identify current barriers to pediatric device 

12 development and incentives to address such barriers. 

13 (c) REPORT.—Not later than 6 months after the 

14 meeting described in subsection (a), the Secretary of 

15 Health and Human Services shall submit to the Com16 mittee on Energy and Commerce of the House of Rep17 resentatives and the Committee on Health, Education, 

18 Labor, and Pensions of the Senate, and publish, including 

19 on the Internet website of the Food and Drug Administra20 tion, a report that summarizes and responds to the rec21 ommendations raised in such meeting. 

Æ 


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