text: 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,''.
target: 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.
feat_title: To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices.