```

[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
```