To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices.

SECTION 1. PRIORITY REVIEW FOR BREAKTHROUGH DEVICES.

    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act is amended--
            (1) in section 515(d)--
                    (A) by striking paragraph (5); and
                    (B) by redesignating paragraph (6) as paragraph 
                (5); and
            (2) by inserting after section 515A (21 U.S.C. 360e-1) the 
        following:

``SEC. 515B. 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 
diseases or conditions, the Secretary shall establish a program to 
provide 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 to, 
        compared to existing approved or cleared alternatives, 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 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 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) Designation determination.--A determination approving 
        or denying a request under subsection (b) shall be considered a 
        significant decision under section 517A and the Secretary shall 
        provide a written, substantive summary of the basis for the 
        determination in accordance with section 517A(a).
            ``(4) Reconsideration.--
                    ``(A) Request for reconsideration.--Any person 
                whose request under subsection (b) is denied may, 
                within 30 days of the denial, request reconsideration 
                of the denial in accordance with section 517A(b)--
                            ``(i) based upon the submission of 
                        documents by such person; or
                            ``(ii) based upon such documents and a 
                        meeting or teleconference.
                    ``(B) Response.--Reconsideration of a designation 
                determination under this paragraph shall be conducted 
                in accordance with section 517A(b).
            ``(5) Withdrawal.--If the Secretary approves a priority 
        review designation for a device under this section, the 
        Secretary may not withdraw the designation based on the fact 
        that the criteria specified in subsection (a) are no longer met 
        because of the subsequent clearance or approval of another 
        device that was designated under--
                    ``(A) this section; or
                    ``(B) section 515(d)(5) (as in effect immediately 
                prior to the enactment of the 21st Century Cures Act).
    ``(d) 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 communication with 
                the sponsor of the device during the review process;
                    ``(E) expedite the Secretary's review of 
                manufacturing and quality systems compliance, as 
                applicable;
                    ``(F) disclose to the sponsor in advance the topics 
                of any consultation concerning the sponsor's device 
                that the Secretary intends to undertake with external 
                experts or an advisory committee and provide the 
                sponsor an opportunity to recommend such external 
                experts;
                    ``(G) for applications submitted under section 
                515(c), provide for advisory committee input, as the 
                Secretary determines appropriate (including in response 
                to the request of the sponsor); 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, such as 
                through adoption of shorter or smaller clinical trials, 
                application of surrogate endpoints, and use of adaptive 
                trial designs and Bayesian statistics, to the extent 
                scientifically appropriate;
                    ``(C) facilitate, to the extent scientifically 
                appropriate, expedited and efficient development and 
                review of the device through utilization of timely 
                postmarket data collection, with regard to applications 
                for approval under section 515(c); and
                    ``(D) agree to clinical protocols that the 
                Secretary will consider binding on the Secretary and 
                the sponsor, subject to--
                            ``(i) changes agreed to by the sponsor and 
                        the Secretary;
                            ``(ii) changes that the Secretary 
                        determines are required to prevent an 
                        unreasonable risk to the public health; or
                            ``(iii) the identification of a substantial 
                        scientific issue determined by the Secretary to 
                        be essential to the safety or effectiveness of 
                        the device involved.
    ``(e) Priority Review Guidance.--
            ``(1) Content.--The Secretary shall issue guidance on the 
        implementation of this section. Such guidance shall include the 
        following:
                    ``(A) The process for a person to seek a priority 
                review designation.
                    ``(B) A template for requests under subsection (b).
                    ``(C) The criteria the Secretary will use in 
                evaluating a request for priority review.
                    ``(D) The standards the Secretary will use in 
                assigning a team of staff, including team leaders, to 
                review devices designated for priority review, 
                including any training required for such personnel on 
                effective and efficient review.
            ``(2) Process.--Prior to finalizing the guidance under 
        paragraph (1), the Secretary shall propose such guidance for 
        public comment.
    ``(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 agency's review of, devices 
        that represent breakthrough technologies.
            ``(2) Construction.--Nothing in this section shall be 
        construed to alter 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 of the least burdensome means of evaluating 
        device effectiveness or demonstrating substantial equivalence 
        between devices with differing technological characteristics, 
        as applicable. Nothing in this section alters the authority of 
        the Secretary to act on an application pursuant to section 
        515(d) before completion of an establishment inspection, as the 
        Secretary deems appropriate.''.
    (b) Conforming Amendment Related to Designation Determinations.--
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 ``an application under section 
515,''.

Summary: This bill amends the Federal Food, Drug, and Cosmetic Act to replace the requirement that the Food and Drug Administration (FDA) prioritize review of breakthrough medical devices with a requirement that the FDA establish a program to provide priority review for breakthrough medical devices. Prior to submitting an application for approval, a medical device sponsor may request that the FDA designate the medical device for priority review. The FDA must provide a summary of the basis for its determination regarding designation. To expedite the development and review of designated medical devices, the FDA must: assign a team of staff for each device, adopt an efficient process for dispute resolution, provide for interactive communication with the device sponsor, expedite review of manufacturing and quality systems compliance, disclose to the sponsor in advance the topics of any consultation between the FDA and external experts or an advisory committee and provide the sponsor the opportunity to recommend external experts, assign staff to address questions by institutional review committees concerning investigational use of the device. The FDA may: (1) coordinate with the sponsor regarding early agreement on a data development plan. (2) take steps to ensure that the design of clinical trials is as efficient as practicable, (3) utilize timely postmarket data collection. And (4) agree to clinical protocols, subject to an FDA determination that changes are required to prevent an unreasonable risk to the public health or that a substantial scientific issue is essential to the safety or effectiveness of the device.