[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1077 Introduced in Senate (IS)]

114th CONGRESS
  1st 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, and Mr. Hatch) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Advancing Breakthrough Devices for 
Patients Act of 2015''.

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) 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--
            ``(1) representing breakthrough technologies;
            ``(2) for which no approved alternatives exist;
            ``(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
            ``(4) the availability of which is in the best interest of 
        patients.
    ``(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).
    ``(c) Designation Process.--
            ``(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.
            ``(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.
            ``(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--
                    ``(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 2015.
    ``(d) Expedited Development and Priority Review.--
            ``(1) Actions.--For purposes of expediting the development 
        and review of devices designated under subsection (c) 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 (b);
                    ``(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;
                    ``(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 
        (c), 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 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;
                    ``(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
                    ``(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.
    ``(e) Priority Review Guidance.--
            ``(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--
                    ``(A) set forth the process by which a person may 
                seek a designation under subsection (c);
                    ``(B) provide a template for requests under 
                subsection (b);
                    ``(C) identify the criteria the Secretary will use 
                in evaluating a request for designation under this 
                section; and
                    ``(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.
            ``(2) Process.--Prior to finalizing the guidance under 
        paragraph (1), the Secretary shall seek public comment on a 
        proposed guidance.
    ``(f) Construction.--
            ``(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.
            ``(2) Rule of construction.--Nothing in this section shall 
        be construed to affect--
                    ``(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;
                    ``(B) the authority of the Secretary with respect 
                to clinical holds under section 520(g)(8)(A); or
                    ``(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.''.
    (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)''.
                                 <all>