Title: Pediatric Device Development Act
Policy area: Health

Summary:
Pediatric Device Development Act
This bill revises requirements for the Food and Drug Administration regarding (1) the annual report on the pediatric use of medical devices, and (2) application procedures for pediatric medical devices.
The bill also extends the authorizations for (1)	the humanitarian device exemption, and (2)	demonstration grants for improving pediatric device availability.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 1093 Introduced in Senate (IS)]

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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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pediatric Device Development Act''.

SEC. 2. PEDIATRIC USES OF DEVICES.

    Section 515A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360e-1) is amended--
            (1) in subsection (a)(3)--
                    (A) by redesignating subparagraphs (B) through (D) 
                as subparagraphs (D) through (F), respectively;
                    (B) by inserting after subparagraph (A) the 
                following:
                    ``(B) an assessment of pediatric device labeling 
                needs, based on a review of real world evidence on the 
                off-label use of medical devices in children, drawn 
                from data available to the Food and Drug 
                Administration;
                    ``(C) the number of devices that receive a 
                humanitarian use exemption under section 520(m);'';
                    (C) in subparagraph (E) (as so redesignated), by 
                striking ``; and'' and inserting ``;'';
                    (D) in subparagraph (F) (as so redesignated), by 
                striking ``(B), and (C).'' and inserting ``(C), (D), 
                and (E); and''; and
                    (E) by adding at the end the following:
                    ``(G) the number of devices for which extrapolation 
                was used to support the approval of pediatric labeling 
                of such devices.
        For the items described in this paragraph, such report shall 
        disaggregate the number of devices by pediatric 
        subpopulation.'';
            (2) by redesignating subsection (c) as subsection (d); and
            (3) by inserting after subsection (b), the following:
    ``(c) Pediatric Device Innovation.--
            ``(1) In general.--The Secretary shall, not later than 1 
        year after the date of enactment of the Pediatric Device 
        Development Act, establish within the Center for Devices and 
        Radiological Health a structure to--
                    ``(A) provide assistance to device manufacturers, 
                in coordination with the relevant review committees, as 
                appropriate, that would result in the development, 
                approval, and labeling of medical devices for children;
                    ``(B) oversee an internal pediatrics team that--
                            ``(i) is comprised of--
                                    ``(I) employees of the Food and 
                                Drug Administration with expertise in 
                                pediatrics and appropriate expertise 
                                pertaining to the relevant devices 
                                under review; and
                                    ``(II) other individuals designated 
                                by the Secretary; and
                            ``(ii) provides expertise and consultation 
                        on--
                                    ``(I) the application of subsection 
                                (b), section 520(m), section 510(k), 
                                and section 522 of this Act and section 
                                402 of the Public Health Service Act to 
                                pediatric devices; and
                                    ``(II) pediatrics, as it pertains 
                                to reviewing devices, to all applicable 
                                divisions within the Center for Devices 
                                and Radiological Health;
                    ``(C) coordinate pediatric activities within the 
                Center for Devices and Radiological Health; and
                    ``(D) collaborate with other programs, offices, and 
                centers of the Food and Drug Administration, including 
                the consortia program authorized under section 305 of 
                the Pediatric Medical Device Safety and Improvement Act 
                of 2007.
            ``(2) Staff.--Such structure shall include a chief 
        pediatric medical officer and other appropriate individuals as 
        the Secretary determines necessary.''.

SEC. 3. HUMANITARIAN DEVICE EXEMPTION.

    Section 520(m) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360j(m)) is amended--
            (1) in paragraph (4)--
                    (A) by striking ``an institutional review 
                committee'' each place such term appears and inserting 
                ``an institutional review board or an appropriate local 
                committee''; and
                    (B) by striking ``the institutional review 
                committee'' and inserting ``the institutional review 
                board or the appropriate local committee''; and
            (2) in paragraph (6)(A)(iv), by striking ``2017'' and 
        inserting ``2022''.

SEC. 4. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC AVAILABILITY.

    Section 305 of the Pediatric Medical Device Safety and Improvement 
Act of 2007 (Public Law 110-85; 42 U.S.C. 282 note) is amended--
            (1) in subsection (c)--
                    (A) in paragraph (4), by striking ``and'' at the 
                end;
                    (B) in paragraph (5), by striking the period and 
                inserting ``; and''; and
                    (C) by adding at the end the following:
            ``(6) providing regulatory consultation to device sponsors 
        in support of the submission of an application for a pediatric 
        device, where appropriate.''; and
            (2) in subsection (e), by striking ``2017'' and inserting 
        ``2022''.

SEC. 5. MEETING ON PEDIATRIC DEVICE DEVELOPMENT.

    (a) In General.--Not later than 1 year after the date of enactment 
of this Act, the Secretary of Health and Human Services shall convene a 
public meeting regarding opportunities and barriers to the development, 
approval, and labeling of pediatric medical devices. Such meeting shall 
include representatives from the medical device industry, academia, 
recipients of funding under section 305 of the Pediatric Medical Device 
Safety and Improvement Act of 2007 (Public Law 110-85; 42 U.S.C. 282 
note), medical provider organizations, and organizations representing 
patients and consumers.
    (b) Topics.--The meeting described in subsection (a) shall include 
consideration of ways to--
            (1) improve research infrastructure and research networks 
        to facilitate the conduct of clinical studies of devices for 
        children that would result in the approval and labeling of 
        medical devices for children;
            (2) appropriately use extrapolation under section 515A(b) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-
        1(b));
            (3) enhance the appropriate use of postmarket registries 
        and data to increase pediatric medical device labeling;
            (4) increase Food and Drug Administration assistance to 
        medical device manufacturers in developing devices for children 
        that are approved and labeled for their use; and
            (5) identify current barriers to pediatric device 
        development and incentives to address such barriers.
    (c) Report.--Not later than 6 months after the meeting described in 
subsection (a), the Secretary of Health and Human Services shall submit 
to the Committee on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and Pensions of the 
Senate, and publish, including on the Internet website of the Food and 
Drug Administration, a report that summarizes and responds to the 
recommendations raised in such meeting.
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