[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2737 Introduced in Senate (IS)]
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114th CONGRESS
2d Session
S. 2737
To improve medical device innovation.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 17, 2016
Ms. Klobuchar (for herself and Mr. Roberts) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To improve medical device innovation.
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 ``Improving Medical Device Innovation
Act''.
SEC. 2. RECOGNITION OF STANDARDS.
(a) In General.--Section 514(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360d(c)) is amended--
(1) in paragraph (1), by inserting after subparagraph (B)
the following new subparagraphs:
``(C)(i) Any person may submit a request for
recognition under subparagraph (A) of all or part of an
appropriate standard established by a nationally or
internationally recognized standard organization.
``(ii) Not later than 60 calendar days after the
Secretary receives such a request, the Secretary
shall--
``(I) make a determination to recognize
all, part, or none of the standard that is the
subject of the request; and
``(II) issue to the person who submitted
such request a response in writing that states
the Secretary's rationale for that
determination, including the scientific,
technical, regulatory, or other basis for such
determination.
``(iii) The Secretary shall take such actions as
may be necessary to implement all or part of a standard
recognized under subclause (I) of clause (ii), in
accordance with subparagraph (A).
``(D) The Secretary shall make publicly available,
in such manner as the Secretary determines appropriate,
the rationale for recognition of all, part, or none of
a standard, including the scientific, technical,
regulatory, or other basis for the decision regarding
such recognition.''; and
(2) by adding at the end the following:
``(4) Training on use of standards.--The Secretary shall
provide to all employees of the Food and Drug Administration
who review premarket submissions for devices periodic training
on the concept and use of recognized standards for purposes of
meeting a premarket submission requirement or other applicable
requirement under this Act, including standards relevant to an
employee's area of device review.''.
(b) Guidance.--The Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall review and update, if
necessary, previously published guidance and standard operating
procedures identifying the principles for recognizing standards, and
for withdrawing the recognition of standards, under section 514(c) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)), taking
into account the experience with and reliance on a standard by foreign
regulatory authorities and the device industry, and whether recognition
of a standard will promote harmonization among regulatory authorities
in the regulation of devices.
SEC. 3. CERTAIN CLASS I AND CLASS II DEVICES.
(a) Class I Devices.--Section 510(l) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(l)) is amended--
(1) by striking ``A report under subsection (k)'' and
inserting ``(1) A report under subsection (k)''; and
(2) by adding at the end the following new paragraph:
``(2) Not later than 120 calendar days after the date of
enactment of the Improving Medical Device Innovation Act and at
least once every 5 years thereafter, as the Secretary
determines appropriate, the Secretary shall identify, through
publication in the Federal Register, any type of class I device
that the Secretary determines no longer requires a report under
subsection (k) to provide reasonable assurance of safety and
effectiveness. Upon such publication--
``(A) each type of class I device so identified
shall be exempt from the requirement for a report under
subsection (k); and
``(B) the classification regulation applicable to
each such type of device shall be deemed amended to
incorporate such exemption.''.
(b) Class II Devices.--Section 510(m) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360(m)) is amended--
(1) by striking paragraph (1) and inserting the following
new paragraph:
``(1) The Secretary shall--
``(A) not later than 90 days after the date of
enactment of the Improving Medical Device Innovation
Act and at least once every 5 years thereafter, as the
Secretary determines appropriate--
``(i) publish in the Federal Register a
notice that contains a list of each type of
class II device that the Secretary determines
no longer requires a report under subsection
(k) to provide reasonable assurance of safety
and effectiveness; and
``(ii) provide for a period of not less
than 60 calendar days for public comment
beginning on the date of the publication of
such notice; and
``(B) not later than 210 calendar days after the
date of enactment of the Improving Medical Device
Innovation Act, publish in the Federal Register a list
representing the Secretary's final determination with
respect to the devices contained in the list published
under subparagraph (A).''; and
(2) in paragraph (2)--
(A) by striking ``1 day after the date of
publication of a list under this subsection,'' and
inserting ``1 calendar day after the date of
publication of the final list under paragraph
(1)(B),''; and
(B) by striking ``30-day period'' and inserting
``60-calendar-day period''; and
(C) by adding at the end the following new
paragraph:
``(3) Upon the publication of the final list under
paragraph (1)(B)--
``(A) each type of class II device so listed shall
be exempt from the requirement for a report under
subsection (k); and
``(B) the classification regulation applicable to
each such type of device shall be deemed amended to
incorporate such exemption.''.
SEC. 4. CLASSIFICATION PANELS.
(a) Classification Panels.--Paragraph (5) of section 513(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended--
(1) by striking ``(5)'' and inserting ``(5)(A)''; and
(2) by adding at the end the following:
``(B) When a device is specifically the subject of
review by a classification panel, the Secretary shall--
``(i) ensure that adequate expertise is
represented on the classification panel to
assess--
``(I) the disease or condition
which the device is intended to cure,
treat, mitigate, prevent, or diagnose;
and
``(II) the technology of the
device; and
``(ii) provide an opportunity for the
person whose device is specifically the subject
of panel review to provide recommendations on
the expertise needed among the voting members
of the panel.
``(C) For purposes of subparagraph (B)(i), the term
`adequate expertise' means that the membership of the
classification panel includes--
``(i) two or more voting members, with a
specialty or other expertise clinically
relevant to the device under review; and
``(ii) at least one voting member who is
knowledgeable about the technology of the
device.
``(D) The Secretary shall provide an annual
opportunity for patients, representatives of patients,
and sponsors of medical device submissions to provide
recommendations for individuals with appropriate
expertise to fill voting member positions on
classification panels.''.
(b) Panel Review Process.--Section 513(b)(6) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360c(b)(6)) is amended--
(1) in subparagraph (A)(iii), by inserting before the
period at the end ``, including by designating a representative
who will be provided a time during the panel meeting to address
the panel individually (or accompanied by experts selected by
such representative) for the purpose of correcting
misstatements of fact or providing clarifying information,
subject to the discretion of the panel chairperson''; and
(2) by striking subparagraph (B) and inserting the
following new subparagraph:
``(B)(i) Any meeting of a classification panel with
respect to the review of a device shall--
``(I) provide adequate time for initial
presentations by the person whose device is
specifically the subject of such review and by
the Secretary; and
``(II) provide adequate time for and
encourage free and open participation by all
interested persons.
``(ii) Following the initial presentations
described in clause (i), the panel may--
``(I) pose questions to the designated
representative described in subparagraph
(A)(iii); and
``(II) consider the responses to such
questions in the panel's review of the
device.''.
SEC. 5. POSTMARKET PILOT TO IMPROVE MEDICAL DEVICE REPORTING.
(a) Pilot Projects.--
(1) In general.--In order to improve the value and
efficiency of reporting so as to advance the objectives of
section 519(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360i(a)), within one year of the date of enactment of
this Act, the Secretary of Health and Human Services shall
establish one or more pilot projects, in coordination with
device manufacturers, to explore and evaluate the use of
alternative methods of compliance with such subsection for
manufacturers of devices described in section 513(a)(1)(C) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360c(a)(1)(C)).
(2) Voluntary participation.--Participation in such pilot
projects shall be voluntary for device manufacturers. The
Secretary may establish the conditions for such voluntary
participation and may establish a process for authorizing
participation.
(3) Purposes.--The pilot projects established under
paragraph (1) shall be designed to--
(A) test methods of reporting for one or more
device types, with priority given to devices for which
device manufacturers submit a relatively high volume of
reports under the regulations implementing section
519(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360i(a));
(B) evaluate forms of data monitoring and reporting
that improve the usability of report data by focusing
on events and information that are most relevant to
reasonably assuring the safety and effectiveness of the
device;
(C) identify methods of reporting that will be
least burdensome for device manufacturers; and
(D) evaluate methods that are alternative to, and
do not duplicate, compliance with requirements of part
803 of title 21, Code of Federal Regulations (or
successor regulations).
(4) Notification to congress.--The Secretary of Health and
Human Services shall notify the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives not later than 18
months after the date of enactment of this Act of the number of
manufacturers that have agreed to participate in a pilot
project under this subsection with the Secretary of Health and
Human Services.
(5) Rule of construction.--Nothing in this subsection shall
limit the authority of the Secretary of Health and Human
Services to provide for alternative methods of medical device
reporting under part 803 of title 21, Code of Federal
Regulations (or successor regulations), including such methods
described in this subsection.
(6) Compliance with requirements for records or reports on
devices.--
(A) In general.--A device manufacturer that
participates in a pilot project under this subsection
shall be required to comply with all applicable
provisions of section 519 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360i), and implementing
regulations, except as described in subparagraph (B).
(B) Conditional exemption.--The Secretary may
determine that, for a specified time period to be
determined by the Secretary, a manufacturer
participating in a pilot project under this subsection
is exempt from certain provisions of section 519(a) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360i(a)), and implementing regulations, if such
manufacturer complies with the conditions set forth in
a pilot project under this subsection.
(b) GAO Review.--
(1) Review of pilot projects.--The Comptroller General of
the United States shall conduct a review of the pilot projects
established under subsection (a), and of the reporting system
under part 803 of title 21, Code of Federal Regulations (or
successor regulations).
(2) Report.--Not later than January 31, 2021, the
Comptroller General of the United States shall submit to
Congress a report containing the results of the review
described in paragraph (1). Such report shall analyze the
value, efficiency, and effectiveness of reporting methods under
subsections (a) and (b) of section 519 of Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360i) and identify any
recommendations for statutory amendments that would enhance the
objectives of section 519(a) of such Act.
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