1.This Act may be cited as
the Pediatric Medical Device Safety
and Improvement Act of 2007
.
2.Tracking
pediatric device approvalsChapter V of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 351 et seq.) is amended by inserting after section 515 the
following:
515A.Pediatric
uses of devices
(a)
(1)A person that submits to the Secretary an application
under section 520(m), or an application (or supplement to an application) or a
product development protocol under section 515, shall include in the
application or protocol the information described in paragraph (2).
(2)The application or protocol described in paragraph
(1) shall include, with respect to the device for which approval is sought and
if readily available—
(A)a description of
any pediatric subpopulations that suffer from the disease or condition that the
device is intended to treat, diagnose, or cure; and
(B)the number of
affected pediatric patients.
(3)Not later than 18 months after the date of enactment of
this section, and annually thereafter, the Secretary shall submit to the
Committee on Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of Representatives a report that
includes—
(A)the number of
devices approved in the year preceding the year in which the report is
submitted, for which there is a pediatric subpopulation that suffers from the
disease or condition that the device is intended to treat, diagnose, or
cure;
(B)the number of
devices approved in the year preceding the year in which the report is
submitted, labeled for use in pediatric patients;
(C)the number of
pediatric devices approved in the year preceding the year in which the report
is submitted, exempted from a fee pursuant to section 738(a)(2)(B)(v);
and
(D)the review time
for each device described in subparagraphs (A), (B), and (C).
(b)Determination
of pediatric effectiveness based on similar course of disease or condition or
similar effect of device on adults
(1)If the course of the disease or condition and the effects
of the device are sufficiently similar in adults and pediatric patients, the
Secretary may conclude that adult data may be used to support a determination
of a reasonable assurance of effectiveness in pediatric populations, as
appropriate.
(2)Extrapolation
between subpopulationsA study may not be needed in each
pediatric subpopulation if data from one subpopulation can be extrapolated to
another subpopulation.
(c)In this section, the term pediatric
subpopulation has the meaning given the term in section
520(m)(6)(E)(ii).
.
3.Modification to
humanitarian device exemption
(a)Section 520(m) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360j(m)) is amended—
(1)in paragraph (3),
by striking No
and inserting Except as provided in
paragraph (6), no
;
(2)in paragraph
(5)—
(A)by inserting
, if the Secretary has reason to believe that the requirements of
paragraph (6) are no longer met,
after public health
;
and
(B)by adding at the
end the following: If the person granted an exemption under paragraph
(2) fails to demonstrate continued compliance with the requirements of this
subsection, the Secretary may suspend or withdraw the exemption from the
effectiveness requirements of sections 514 and 515 for a humanitarian device
only after providing notice and an opportunity for an informal
hearing.
;
(3)by striking
paragraph (6) and inserting the following:
(6)(A)Except as provided in
subparagraph (D), the prohibition in paragraph (3) shall not apply with respect
to a person granted an exemption under paragraph (2) if each of the following
conditions apply:
(i)(I)The device with respect
to which the exemption is granted is intended for the treatment or diagnosis of
a disease or condition that occurs in pediatric patients or in a pediatric
subpopulation, and such device is labeled for use in pediatric patients or in a
pediatric subpopulation in which the disease or condition occurs.
(II)The device was not previously
approved under this subsection for the pediatric patients or the pediatric
subpopulation described in subclause (I) prior to the date of enactment of the
Pediatric Medical Device Safety and
Improvement Act of 2007.
(ii)During any calendar year, the number
of such devices distributed during that year does not exceed the annual
distribution number specified by the Secretary when the Secretary grants such
exemption. The annual distribution number shall be based on the number of
individuals affected by the disease or condition that such device is intended
to treat, diagnose, or cure, and of that number, the number of individuals
likely to use the device, and the number of devices reasonably necessary to
treat such individuals. In no case shall the annual distribution number exceed
the number identified in paragraph (2)(A).
(iii)Such person immediately notifies the
Secretary if the number of such devices distributed during any calendar year
exceeds the annual distribution number referred to in clause (ii).
(iv)The request for such exemption is
submitted on or before October 1, 2013.
(B)The Secretary may inspect the records
relating to the number of devices distributed during any calendar year of a
person granted an exemption under paragraph (2) for which the prohibition in
paragraph (3) does not apply.
(C)A person may petition the Secretary
to modify the annual distribution number specified by the Secretary under
subparagraph (A)(ii) with respect to a device if additional information on the
number of individuals affected by the disease or condition arises, and the
Secretary may modify such number but in no case shall the annual distribution
number exceed the number identified in paragraph (2)(A).
(D)If a person notifies the Secretary,
or the Secretary determines through an inspection under subparagraph (B), that
the number of devices distributed during any calendar year exceeds the annual
distribution number, as required under subparagraph (A)(iii), and modified
under subparagraph (C), if applicable, then the prohibition in paragraph (3)
shall apply with respect to such person for such device for any sales of such
device after such notification.
(E)(i)In this subsection, the
term pediatric patients means patients who are 21 years of age or
younger at the time of the diagnosis or treatment.
(ii)In this subsection, the term
pediatric subpopulation means 1 of the following
populations:
(I)Neonates.
(II)Infants.
(III)Children.
(IV)Adolescents.
;
and
(4)by adding at the
end the following:
(7)The Secretary shall refer any report
of an adverse event regarding a device for which the prohibition under
paragraph (3) does not apply pursuant to paragraph (6)(A) that the Secretary
receives to the Office of Pediatric Therapeutics, established under section 6
of the Best Pharmaceuticals for Children Act (Public Law 107–109)). In
considering the report, the Director of the Office of Pediatric Therapeutics,
in consultation with experts in the Center for Devices and Radiological Health,
shall provide for periodic review of the report by the Pediatric Advisory
Committee, including obtaining any recommendations of such committee regarding
whether the Secretary should take action under this Act in response to the
report.
.
(b)Not
later than January 1, 2012, the Comptroller General of the United States shall
submit to the Committee on Health, Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the House of Representatives a
report on the impact of allowing persons granted an exemption under section
520(m)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j(m)(2)) with respect to a device to
profit from such device pursuant to section 520(m)(6) of such Act (21 U.S.C. 360j(m)(6)) (as amended by
subsection (a)), including—
(1)an assessment of
whether such section 520(m)(6) (as amended by subsection (a)) has increased the
availability of pediatric devices for conditions that occur in small numbers of
children, including any increase or decrease in the number of—
(A)exemptions
granted under such section 520(m)(2) for pediatric devices; and
(B)applications
approved under section 515 of such Act (21 U.S.C. 360e) for devices intended to
treat, diagnose, or cure conditions that occur in pediatric patients or for
devices labeled for use in a pediatric population;
(2)the conditions or
diseases the pediatric devices were intended to treat or diagnose and the
estimated size of the pediatric patient population for each condition or
disease;
(3)the costs of the
pediatric devices, based on a survey of children's hospitals;
(4)the extent to
which the costs of such devices are covered by health insurance;
(5)the impact, if
any, of allowing profit on access to such devices for patients;
(6)the profits made
by manufacturers for each device that receives an exemption;
(7)an estimate of
the extent of the use of the pediatric devices by both adults and pediatric
populations for a condition or disease other than the condition or disease on
the label of such devices;
(8)recommendations
of the Comptroller General of the United States regarding the effectiveness of
such section 520(m)(6) (as amended by subsection (a)) and whether any
modifications to such section 520(m)(6) (as amended by subsection (a)) should
be made;
(9)existing
obstacles to pediatric device development; and
(10)an evaluation of
the demonstration grants described in section 5.
(c)Not
later than 180 days after the date of enactment of this Act, the Commissioner
of Food and Drugs shall issue guidance for institutional review committees on
how to evaluate requests for approval for devices for which a humanitarian
device exemption under section 520(m)(2) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360j(m)(2)) has been granted.
4.Encouraging
pediatric medical device research
(a)The Director of the National Institutes of Health shall
designate a contact point or office at the National Institutes of Health to
help innovators and physicians access funding for pediatric medical device
development.
(b)Plan for
pediatric medical device research
(1)Not later than 180 days after the date of enactment of
this Act, the Commissioner of Food and Drugs, in collaboration with the
Director of the National Institutes of Health and the Director of the Agency
for Healthcare Research and Quality, shall submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives a plan for expanding pediatric medical
device research and development. In developing such plan, the Commissioner of
Food and Drugs shall consult with individuals and organizations with
appropriate expertise in pediatric medical devices.
(2)The
plan under paragraph (1) shall include—
(A)the current
status of federally funded pediatric medical device research;
(B)any gaps in such
research, which may include a survey of pediatric medical providers regarding
unmet pediatric medical device needs, as needed; and
(C)a research agenda
for improving pediatric medical device development and Food and Drug
Administration clearance or approval of pediatric medical devices, and for
evaluating the short- and long-term safety and effectiveness of pediatric
medical devices.
5.Demonstration
grants for improving pediatric device availability
(a)
(1)Not later than 90 days after the date of enactment of
this Act, the Secretary of Health and Human Services shall issue a request for
proposals for 1 or more grants or contracts to nonprofit consortia for
demonstration projects to promote pediatric device development.
(2)Determination
on grants or contractsNot later than 180 days after the date the
Secretary of Health and Human Services issues a request for proposals under
paragraph (1), the Secretary shall make a determination on the grants or
contracts under this section.
(b)A
nonprofit consortium that desires to receive a grant or contract under this
section shall submit an application to the Secretary of Health and Human
Services at such time, in such manner, and containing such information as the
Secretary may require.
(c)A nonprofit consortium that receives a grant or contract
under this section shall—
(1)encourage
innovation by connecting qualified individuals with pediatric device ideas with
potential manufacturers;
(2)mentor and manage
pediatric device projects through the development process, including product
identification, prototype design, device development, and marketing;
(3)connect
innovators and physicians to existing Federal resources, including resources
from the Food and Drug Administration, the National Institutes of Health, the
Small Business Administration, the Department of Energy, the Department of
Education, the National Science Foundation, the Department of Veterans Affairs,
the Agency for Healthcare Research and Quality, and the National Institute of
Standards and Technology;
(4)assess the
scientific and medical merit of proposed pediatric device projects;
(5)assess business
feasibility and provide business advice;
(6)provide
assistance with prototype development; and
(7)provide
assistance with postmarket needs, including training, logistics, and
reporting.
(d)
(1)National
institutes of healthEach consortium that receives a grant or
contract under this section shall—
(A)coordinate with
the National Institutes of Health's pediatric device contact point or office,
designated under section 4; and
(B)provide to the
National Institutes of Health any identified pediatric device needs that the
consortium lacks sufficient capacity to address or those needs in which the
consortium has been unable to stimulate manufacturer interest.
(2)Food and drug
administrationEach consortium that receives a grant or contract
under this section shall coordinate with the Commissioner of Food and Drugs and
device companies to facilitate the application for approval or clearance of
devices labeled for pediatric use.
(e)Authorization
of appropriationsThere are authorized to be appropriated to
carry out this section $6,000,000 for each of fiscal years 2008 through
2012.
6.Amendments to
Office of Pediatric Therapeutics and Pediatric Advisory Committee
(a)Office of
Pediatric TherapeuticsSection 6(b) of the Best Pharmaceuticals
for Children Act (21 U.S.C. 393a(b)) is amended by inserting , including
increasing pediatric access to medical devices
after pediatric
issues
.
(b)Pediatric
Advisory CommitteeSection 14 of the Best Pharmaceuticals for
Children Act (42 U.S.C. 284m note) is amended—
(1)in subsection
(a), by inserting (including drugs and biological products) and medical
devices
after therapeutics
; and
(2)in subsection
(b)—
(A)in paragraph (1),
by inserting (including drugs and biological products) and medical
devices
after therapeutics
; and
(B)in paragraph
(2)—
(i)in
subparagraph (A), by striking and 505B
and inserting
505B, 510(k), 515, and 520(m)
;
(ii)by
striking subparagraph (B) and inserting the following:
(B)identification of
research priorities related to therapeutics (including drugs and biological
products) and medical devices for pediatric populations and the need for
additional diagnostics and treatments for specific pediatric diseases or
conditions; and
;
and
(iii)in subparagraph
(C), by inserting (including drugs and biological products) and medical
devices
after therapeutics
.
7.
(a)Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l)
is amended—
(1)in subsection (a)—
(A)by inserting
, or as a condition to approval of an application (or a supplement to an
application) or a product development protocol under section 515 or as a
condition to clearance of a premarket notification under section
510(k),
after The Secretary may by order
; and
(B)by inserting , that is expected to
have significant use in pediatric populations,
after health
consequences
; and
(2)in subsection
(b)—
(A)by striking
(b) surveillance
approval.—Each
and inserting the following:
(b)
(1)Each
;
(B)by striking
The Secretary, in consultation
and inserting Except as
provided in paragraph (2), the Secretary, in consultation
;
(C)by striking
Any determination
and inserting Except as provided in
paragraph (2), any determination
; and
(D)by adding at the
end the following:
(2)Longer studies
for pediatric devicesThe Secretary may by order require a
prospective surveillance period of more than 36 months with respect to a device
that is expected to have significant use in pediatric populations if such
period of more than 36 months is necessary in order to assess the impact of the
device on growth and development, or the effects of growth, development,
activity level, or other factors on the safety or efficacy of the
device.
.
(b)
(1)
(A)The
Secretary of Health and Human Services, acting through the Commissioner of Food
and Drugs, shall establish a publicly accessible database of studies of medical
devices that includes all studies and surveillances, described in paragraph
(2)(A), that were in progress on the date of enactment of this Act or that
began after such date.
(B)Information
included in the database under subparagraph (A) shall be in language reasonably
accessible and understood by individuals without specific expertise in the
medical field.
(2)Studies and
surveillances
(A)The
database described in paragraph (1) shall include—
(i)all
postmarket surveillances ordered under section 522(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360l(a)) or agreed to by the manufacturer;
and
(ii)all studies
agreed to by the manufacturer of a medial device as part of—
(I)the premarket
approval of such device under section 515 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360e);
(II)the clearance of
a premarket notification report under section 510(k) of such Act (21 U.S.C.
360(k)) with respect to such device; or
(III)the submission
of an application under section 520(m) of such Act (21 U.S.C. 360j(m)) with
respect to such device.
(B)The
database described in paragraph (1) shall not include any studies with respect
to a medical device that were completed prior to the initial approval of such
device.
(3)Contents of
study and surveillanceFor each study or surveillance included in
the database described in paragraph (1), the database shall include—
(A)information on
the status of the study or surveillance;
(B)basic information
about the study or surveillance, including the purpose, the primary and
secondary outcomes, and the population targeted;
(C)the expected
completion date of the study or surveillance;
(D)public health
notifications, including safety alerts; and
(E)any other
information the Secretary of Health and Human Services determines appropriate
to protect the public health.
(4)Once completed
or terminatedIn addition to the information described in
paragraph (3), once a study or surveillance has been completed or if a study or
surveillance is terminated, the database shall also include—
(A)the actual date
of completion or termination;
(B)if the study or
surveillance was terminated, the reason for termination;
(C)if the study or
surveillance was submitted but not accepted by the Food and Drug Administration
because the study or surveillance did not meet the requirements for such study
or surveillance, an explanation of the reasons and any follow-up action
required;
(D)information about
any labeling changes made to the device as a result of the study or
surveillance findings;
(E)information about
any other decisions or actions of the Food and Drug Administration that result
from the study or surveillance findings;
(F)lay and technical
summaries of the study or surveillance results and key findings, or an
explanation as to why the results and key findings do not warrant public
availability;
(G)a link to any
peer reviewed articles on the study or surveillance; and
(H)any other
information the Secretary of Health and Human Services determines appropriate
to protect the public health.
(5)The database described in paragraph (1) shall be—
(A)accessible to the
general public; and
(B)easily searchable
by multiple criteria, including whether the study or surveillance involves
pediatric populations.