[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1077 Reported in Senate (RS)]
<DOC>
Calendar No. 412
114th CONGRESS
2d Session
S. 1077
To provide for expedited development of and priority review for
breakthrough devices.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 23, 2015
Mr. Burr (for himself, Mr. Bennet, Mr. Hatch, and Mr. Donnelly)
introduced the following bill; which was read twice and referred to the
Committee on Health, Education, Labor, and Pensions
April 5, 2016
Reported by Mr. Alexander, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
To provide for expedited development of and priority review for
breakthrough devices.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Advancing Breakthrough
Devices for Patients Act of 2015''.</DELETED>
<DELETED>SEC. 2. EXPEDITED DEVELOPMENT OF AND PRIORITY REVIEW FOR
BREAKTHROUGH DEVICES.</DELETED>
<DELETED> (a) In General.--Chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after
section 515A the following:</DELETED>
<DELETED>``SEC. 515B. EXPEDITED DEVELOPMENT OF AND PRIORITY REVIEW FOR
BREAKTHROUGH DEVICES.</DELETED>
<DELETED> ``(a) In General.--In order to provide for more effective
treatment or diagnosis of life-threatening or irreversibly debilitating
human disease or conditions, the Secretary shall establish a program to
expedite the development of and provide for the priority review for
devices--</DELETED>
<DELETED> ``(1) representing breakthrough
technologies;</DELETED>
<DELETED> ``(2) for which no approved alternatives
exist;</DELETED>
<DELETED> ``(3) offering significant advantages over
existing approved or cleared alternatives, including the
potential, compared to existing approved alternatives, to
reduce or eliminate the need for hospitalization, improve
patient quality of life, facilitate patients' ability to manage
their own care (such as through self-directed personal
assistance), or establish long-term clinical efficiencies;
or</DELETED>
<DELETED> ``(4) the availability of which is in the best
interest of patients.</DELETED>
<DELETED> ``(b) Request for Designation.--A sponsor of a device may
request that the Secretary designate the device for expedited
development and priority review under this section. Any such request
for designation may be made at any time prior to the submission of an
application under section 515(c), a petition for classification under
section 513(f)(2), or a notification under section 510(k).</DELETED>
<DELETED> ``(c) Designation Process.--</DELETED>
<DELETED> ``(1) In general.--Not later than 60 calendar days
after the receipt of a request under subsection (b), the
Secretary shall determine whether the device that is the
subject of the request meets the criteria described in
subsection (a). If the Secretary determines that the device
meets the criteria, the Secretary shall designate the device
for expedited development and priority review.</DELETED>
<DELETED> ``(2) Review.--Review of a request under
subsection (b) shall be undertaken by a team that is composed
of experienced staff and managers of the Food and Drug
Administration and is chaired by a senior manager.</DELETED>
<DELETED> ``(3) Withdrawal.--The Secretary may not withdraw
a designation granted under this section on the basis of the
criteria under subsection (a) no longer applying because of the
subsequent clearance or approval of another device that--
</DELETED>
<DELETED> ``(A) was designated under this section;
or</DELETED>
<DELETED> ``(B) was given priority review under
section 515(d)(5), as in effect prior to the date of
enactment of the Advancing Breakthrough Devices for
Patients Act of 2015.</DELETED>
<DELETED> ``(d) Expedited Development and Priority Review.--
</DELETED>
<DELETED> ``(1) Actions.--For purposes of expediting the
development and review of devices designated under subsection
(c) the Secretary shall--</DELETED>
<DELETED> ``(A) assign a team of staff, including a
team leader with appropriate subject matter expertise
and experience, for each device for which a request is
submitted under subsection (b);</DELETED>
<DELETED> ``(B) provide for oversight of the team by
senior agency personnel to facilitate the efficient
development of the device and the efficient review of
any submission described in subsection (b) for the
device;</DELETED>
<DELETED> ``(C) adopt an efficient process for
timely dispute resolution;</DELETED>
<DELETED> ``(D) provide for interactive and timely
communication with the sponsor of the device during the
development program and review process;</DELETED>
<DELETED> ``(E) expedite the Secretary's review of
manufacturing and quality systems compliance, as
applicable;</DELETED>
<DELETED> ``(F) disclose to the sponsor not less
than 5 business days in advance the topics of any
consultation the Secretary intends to undertake with
external experts or an advisory committee concerning
the sponsor's device and provide the sponsor the
opportunity to recommend such external
experts;</DELETED>
<DELETED> ``(G) provide for advisory committee
input, as the Secretary determines appropriate
(including in response to the request of the sponsor)
for applications submitted under section 515(c);
and</DELETED>
<DELETED> ``(H) assign staff to be available within
a reasonable time to address questions by institutional
review committees concerning the conditions and
clinical testing requirements applicable to the
investigational use of the device pursuant to an
exemption under section 520(g).</DELETED>
<DELETED> ``(2) Additional actions.--In addition to the
actions described in paragraph (1), for purposes of expediting
the development and review of devices designated under
subsection (c), the Secretary, in collaboration with the device
sponsor, may, as appropriate--</DELETED>
<DELETED> ``(A) coordinate with the sponsor
regarding early agreement on a data development
plan;</DELETED>
<DELETED> ``(B) take steps to ensure that the design
of clinical trials is as efficient as practicable, when
scientifically appropriate, such as through adoption of
shorter or smaller clinical trials, application of
surrogate endpoints, and the use of adaptive trial
designs and Bayesian statistics, to the extent
scientifically appropriate;</DELETED>
<DELETED> ``(C) facilitate, when scientifically
appropriate, expedited and efficient development and
review of the device through utilization of timely
post-market data collection with regard to application
for approval under section 515(c); and</DELETED>
<DELETED> ``(D) agree in writing to clinical
protocols that the Secretary will consider binding on
the Secretary and the sponsor, subject to--</DELETED>
<DELETED> ``(i) changes to such protocols
agreed to in writing by the sponsor and the
Secretary; or</DELETED>
<DELETED> ``(ii) a decision, made by the
director of the office responsible for
reviewing the device submission, that a
substantial scientific issue essential to
determining the safety or effectiveness of such
device exists, provided that such decision is
in writing, and is made only after the
Secretary provides to the device sponsor or
applicant an opportunity for a meeting at which
the director and the sponsor or applicant are
present and at which the director documents the
substantial scientific issue.</DELETED>
<DELETED> ``(e) Priority Review Guidance.--</DELETED>
<DELETED> ``(1) Content.--Not later than 1 year after the
date of enactment of the Advancing Breakthrough Devices for
Patients Act of 2015, the Secretary shall issue guidance on the
implementation of this section. Such guidance shall--</DELETED>
<DELETED> ``(A) set forth the process by which a
person may seek a designation under subsection
(c);</DELETED>
<DELETED> ``(B) provide a template for requests
under subsection (b);</DELETED>
<DELETED> ``(C) identify the criteria the Secretary
will use in evaluating a request for designation under
this section; and</DELETED>
<DELETED> ``(D) identify the standards the Secretary
will use in assigning a team of staff, including team
leaders, to review devices designated for expedited
development and priority review, including any training
required for such personnel to ensure effective and
efficient review.</DELETED>
<DELETED> ``(2) Process.--Prior to finalizing the guidance
under paragraph (1), the Secretary shall seek public comment on
a proposed guidance.</DELETED>
<DELETED> ``(f) Construction.--</DELETED>
<DELETED> ``(1) Purpose.--This section is intended to
encourage the Secretary and provide the Secretary sufficient
authorities to apply efficient and flexible approaches to
expedite the development of, and prioritize the Food and Drug
Administration's review of, devices that represent breakthrough
devices.</DELETED>
<DELETED> ``(2) Rule of construction.--Nothing in this
section shall be construed to affect--</DELETED>
<DELETED> ``(A) the criteria and standards for
evaluating an application pursuant to section 515(c), a
report and request for classification under section
513(f)(2), or a report under section 510(k), including
the recognition of valid scientific evidence as
described in section 513(a)(3)(B) and consideration and
application of the least burdensome means of evaluating
device effectiveness or demonstrating substantial
equivalence between devices with differing
technological characteristics, as applicable;</DELETED>
<DELETED> ``(B) the authority of the Secretary with
respect to clinical holds under section 520(g)(8)(A);
or</DELETED>
<DELETED> ``(C) the authority of the Secretary to
act on an application pursuant to section 515(d) before
completion of an establishment inspection, as the
Secretary determines appropriate.''.</DELETED>
<DELETED> (b) Documentation and Review of Significant Decisions.--
Section 517A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360g-1(a)(1)) is amended by inserting ``a request for
designation under section 515B,'' after ``application under section
515,''.</DELETED>
<DELETED> (c) Termination of Previous Program.--</DELETED>
<DELETED> (1) In general.--Section 515(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360e(d)) is amended--
</DELETED>
<DELETED> (A) by striking paragraph (5);
and</DELETED>
<DELETED> (B) by redesignating paragraph (6) as
paragraph (5).</DELETED>
<DELETED> (2) Conforming amendment.--Section 737(5) of the
Federal Food, Drug, and Cosmetics Act (21 U.S.C. 379i(5)) is
amended by striking ``515(d)(6)'' and inserting
``515(d)(5)''.</DELETED>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Advancing Breakthrough Devices for
Patients Act of 2016''.
SEC. 2. EXPEDITED DEVELOPMENT OF AND PRIORITY REVIEW FOR BREAKTHROUGH
DEVICES.
(a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 515A
the following:
``SEC. 515B. EXPEDITED DEVELOPMENT OF AND PRIORITY REVIEW FOR
BREAKTHROUGH DEVICES.
``(a) Purpose.--The purpose of this section is to encourage the
Secretary, and provide the Secretary with sufficient authority, to
apply efficient and flexible approaches to expedite the development of,
and prioritize the Food and Drug Administration's review of, devices
that represent breakthrough technologies.
``(b) Establishment of Program.--The Secretary shall establish a
program to expedite the development of and provide for the priority
review for devices, as determined by the Secretary--
``(1) that provide for more effective treatment or
diagnosis of life-threatening or irreversibly debilitating
human disease or conditions; and
``(2)(A) that represent breakthrough technologies;
``(B) for which no approved or cleared alternatives exist;
``(C) that offer significant advantages over existing
approved or cleared alternatives, including the potential,
compared to existing approved alternatives, to reduce or
eliminate the need for hospitalization, improve patient quality
of life, facilitate patients' ability to manage their own care
(such as through self-directed personal assistance), or
establish long-term clinical efficiencies; or
``(D) the availability of which is in the best interest of
patients.
``(c) Request for Designation.--A sponsor of a device may request
that the Secretary designate such device for expedited development and
priority review under this section. Any such request for designation
may be made at any time prior to the submission of an application under
section 515(c) or a petition for classification under section
513(f)(2).
``(d) Designation Process.--
``(1) In general.--Not later than 60 calendar days after
the receipt of a request under subsection (c), the Secretary
shall determine whether the device that is the subject of the
request meets the criteria described in subsection (b). If the
Secretary determines that the device meets the criteria, the
Secretary shall designate the device for expedited development
and priority review.
``(2) Review.--Review of a request under subsection (c)
shall be undertaken by a team that is composed of experienced
staff and senior managers of the Food and Drug Administration.
``(3) Withdrawal.--The Secretary may not withdraw a
designation granted under this section on the basis of the
criteria under subsection (b) no longer applying because of the
subsequent clearance or approval of another device that--
``(A) was designated under this section; or
``(B) was given priority review under section
515(d)(5), as in effect prior to the date of enactment
of the Advancing Breakthrough Devices for Patients Act
of 2016.
``(e) Expedited Development and Priority Review.--
``(1) Actions.--For purposes of expediting the development
and review of devices designated under subsection (d) the
Secretary shall--
``(A) assign a team of staff, including a team
leader with appropriate subject matter expertise and
experience, for each device for which a request is
submitted under subsection (c);
``(B) provide for oversight of the team by senior
agency personnel to facilitate the efficient
development of the device and the efficient review of
any submission described in subsection (c) for the
device;
``(C) adopt an efficient process for timely dispute
resolution;
``(D) provide for interactive and timely
communication with the sponsor of the device during the
development program and review process;
``(E) expedite the Secretary's review of
manufacturing and quality systems compliance, as
applicable;
``(F) disclose to the sponsor, not less than 5
business days in advance, the topics of any
consultation the Secretary intends to undertake with
external experts or an advisory committee concerning
the sponsor's device and provide the sponsor the
opportunity to recommend such external experts;
``(G) provide for advisory committee input, as the
Secretary determines appropriate (including in response
to the request of the sponsor) for applications
submitted under section 515(c); and
``(H) assign staff to be available within a
reasonable time to address questions by institutional
review committees concerning the conditions and
clinical testing requirements applicable to the
investigational use of the device pursuant to an
exemption under section 520(g).
``(2) Additional actions.--In addition to the actions
described in paragraph (1), for purposes of expediting the
development and review of devices designated under subsection
(d), the Secretary, in collaboration with the device sponsor,
may, as appropriate--
``(A) coordinate with the sponsor regarding early
agreement on a data development plan;
``(B) take steps to ensure that the design of
clinical trials is as efficient and flexible as
practicable, when scientifically appropriate;
``(C) facilitate, when scientifically appropriate,
expedited and efficient development and review of the
device through utilization of timely postmarket data
collection with regard to application for approval
under section 515(c); and
``(D) agree in writing to clinical protocols that
the Secretary will consider binding on the Secretary
and the sponsor, subject to--
``(i) changes to such protocols agreed to
in writing by the sponsor and the Secretary; or
``(ii) a decision, made by the director of
the office responsible for reviewing the device
submission, that a substantial scientific issue
essential to determining the safety or
effectiveness of such device exists, provided
that such decision is in writing, and is made
only after the Secretary provides to the device
sponsor or applicant an opportunity for a
meeting at which the director and the sponsor
or applicant are present and at which the
director documents the substantial scientific
issue.
``(f) Priority Review Guidance.--
``(1) Content.--Not later than 1 year after the date of
enactment of the Advancing Breakthrough Devices for Patients
Act of 2016, the Secretary shall issue guidance on the
implementation of this section. Such guidance shall--
``(A) set forth the process by which a person may
seek a designation under subsection (d);
``(B) provide a template for requests under
subsection (c);
``(C) identify the criteria the Secretary will use
in evaluating a request for designation under this
section; and
``(D) identify the criteria and processes the
Secretary will use to assign a team of staff, including
team leaders, to review devices designated for
expedited development and priority review, including
any training required for such personnel to ensure
effective and efficient review.
``(2) Process.--Prior to finalizing the guidance under
paragraph (1), the Secretary shall seek public comment on a
proposed guidance.
``(g) Rule of Construction.--Nothing in this section shall be
construed to affect--
``(1) the criteria and standards for evaluating an
application pursuant to section 515(c), a report and request
for classification under section 513(f)(2), or a report under
section 510(k), including the recognition of valid scientific
evidence as described in section 513(a)(3)(B) and consideration
and application of the least burdensome means of evaluating
device effectiveness or demonstrating substantial equivalence
between devices with differing technological characteristics,
as applicable;
``(2) the authority of the Secretary with respect to
clinical holds under section 520(g)(8)(A);
``(3) the authority of the Secretary to act on an
application pursuant to section 515(d) before completion of an
establishment inspection, as the Secretary determines
appropriate; or
``(4) the authority of the Secretary with respect to
postmarket surveillance under sections 519(h) and 522.''.
(b) Documentation and Review of Significant Decisions.--Section
517A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g-
1(a)(1)) is amended by inserting ``a request for designation under
section 515B,'' after ``application under section 515,''.
(c) Termination of Previous Program.--
(1) In general.--Section 515(d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360e(d)) is amended--
(A) by striking paragraph (5); and
(B) by redesignating paragraph (6) as paragraph
(5).
(2) Conforming amendment.--Section 737(5) of the Federal
Food, Drug, and Cosmetics Act (21 U.S.C. 379i(5)) is amended by
striking ``515(d)(6)'' and inserting ``515(d)(5)''.
(d) Report.--On January 1, 2017, the Secretary of Health and Human
Services, acting through the Commissioner of Food and Drugs, shall
issue a report to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce of the
House of Representatives--
(1) on the program under section 515B of Federal Food,
Drug, and Cosmetic Act, as added by this Act, in bringing safe
and effective devices included in such program to patients as
soon as possible; and
(2) that includes recommendations, if any, to strengthen
the program to better meet patient device needs in a manner as
timely as possible.
Calendar No. 412
114th CONGRESS
2d Session
S. 1077
_______________________________________________________________________
A BILL
To provide for expedited development of and priority review for
breakthrough devices.
_______________________________________________________________________
April 5, 2016
Reported with an amendment