text: SECTION 1. SHORT TITLE.
  
      This Act may be cited as the ``Medical Device Safety Monitoring 
  Act''.
  
  SEC. 2. DEVICE PILOT PROJECTS.
  
      (a) Postmarket Pilot.--Section 519 of the Federal Food, Drug, and 
  Cosmetic Act (21 U.S.C. 360i) is amended by adding at the end the 
  following:
      ``(i) Pilot Projects.--
              ``(1) In general.--In order to provide timely and reliable 
          information on the safety and effectiveness of cleared or 
          approved devices, including responses to adverse events and 
          malfunctions, and to advance the objectives of part 803 of 
          title 21, Code of Federal Regulations (or successor 
          regulations), and advance the objectives of, and evaluate 
          innovative new methods of compliance with, this section and 
          section 522, the Secretary shall, within one year of the date 
          of enactment of this subsection, initiate one or more pilot 
          projects for voluntary participation by a manufacturer or 
          manufacturers of device or device type, or continue existing 
          projects in accordance with paragraph (3), that meet all of the 
          following requirements:
                      ``(A) Are designed to efficiently generate reliable 
                  and timely safety and active surveillance data for use 
                  by the Secretary or manufacturers of the devices that 
                  are involved in the pilot project.
                      ``(B) Inform the development of methods, systems, 
                  data criteria, and programs that could be used to 
                  support safety and active surveillance activities for 
                  devices not included in such project.
                      ``(C) Are designed and conducted in coordination 
                  with a comprehensive system for evaluating medical 
                  device technology that operates under a governing board 
                  with appropriate representation of stakeholders, 
                  including consumer groups and device manufacturers.
                      ``(D) Use electronic health data including claims 
                  data, patient survey data, and any other data, as the 
                  Secretary determines appropriate.
                      ``(E) Prioritize devices and device types that meet 
                  one or more of the following criteria:
                              ``(i) Devices and device types for which 
                          the collection and analysis of real world 
                          evidence regarding a device's safety and 
                          effectiveness is likely to advance public 
                          health.
                              ``(ii) Devices and device types that are 
                          widely used.
                              ``(iii) Devices and device types, the 
                          failure of which has significant health 
                          consequences.
                              ``(iv) Devices and device types for which 
                          the Secretary has received public 
                          recommendations in accordance with paragraph 
                          (2)(B) and has determined to meet one of the 
                          criteria under clauses (i) through (iii) and is 
                          appropriate for a project under this 
                          subsection.
              ``(2) Participation.--The Secretary shall establish the 
          conditions and processes for--
                      ``(A) authorizing voluntary participation of a 
                  manufacturer of a device in the pilot project described 
                  in paragraph (1); and
                      ``(B) facilitating public recommendations for 
                  devices to be prioritized under the pilot project 
                  described in paragraph (1), including requirements for 
                  the data necessary to support such recommendation.
              ``(3) Implementation.--The Secretary may satisfy the 
          requirements of paragraphs (1) and (2) by continuing or 
          expanding existing projects, or by beginning new projects, that 
          meet the criteria of subparagraphs (A) through (E) of paragraph 
          (1) or by entering into contracts, cooperative agreements, 
          grants, or other appropriate agreements with public or private 
          entities that have a significant presence in the United States, 
          and meet the following additional conditions:
                      ``(A) If such public or private entities are a 
                  component of another organization, the entities have 
                  established appropriate security measures to maintain 
                  the confidentiality and privacy of the data described 
                  in paragraph (1)(D) and the entity shall not make an 
                  unauthorized disclosure of such data to the other 
                  components of the organization in breach of such 
                  confidentiality and privacy requirements.
                      ``(B) In the case of the termination or nonrenewal 
                  of such contracts, cooperative agreements, grants, or 
                  other appropriate agreements, the entities shall comply 
                  with each of the following:
                              ``(i) Continue to comply with the 
                          confidentiality and privacy requirements under 
                          this subsection with respect to all data 
                          disclosed to the entity.
                              ``(ii) Return any data disclosed to such 
                          entity under this subsection to which it would 
                          not otherwise have access or, if returning the 
                          data is not practicable, destroy the data.
                      ``(C) Have at least one of the following 
                  qualifications:
                              ``(i) Research, statistical, epidemiologic, 
                          or clinical capability and expertise to conduct 
                          and complete the activities under this 
                          subsection, including the capability and 
                          expertise to provide the Secretary access to 
                          de-identified data consistent with the 
                          requirements of this subsection.
                              ``(ii) An information technology 
                          infrastructure in place to support electronic 
                          data and operational standards to provide 
                          security for such data, as appropriate.
                              ``(iii) Experience with, and expertise on, 
                          the development of device safety and 
                          effectiveness research and surveillance using 
                          electronic health data.
                              ``(iv) Other expertise which the Secretary 
                          determines necessary to fulfill the activities 
                          under this subsection.
              ``(4) Review of contract in the event of a merger or 
          acquisition.--The Secretary shall review a contract with a 
          qualified entity under this subsection in the event of a merger 
          or acquisition of the entity in order to ensure that the 
          requirements under this subsection will continue to be met.
              ``(5) Report to congress.--Not later than 18 months after 
          the date of enactment of this subsection, and annually 
          thereafter, the Secretary shall submit to the Committee on 
          Health, Education, Labor, and Pensions of the Senate and the 
          Committee on Energy and Commerce of the House of 
          Representatives a report containing a description of the pilot 
          projects being conducted pursuant to this subsection, including 
          for each pilot project--
                      ``(A) how the project is being implemented in 
                  accordance with paragraph (3) and the contractor or 
                  grantee as applicable;
                      ``(B) the number of manufacturers that have agreed 
                  to participate;
                      ``(C) the data sources used;
                      ``(D) the devices or device categories involved; 
                  and
                      ``(E) the number of patients involved.
              ``(6) Compliance with requirements for records or reports 
          on devices.--The participation of a manufacturer in a pilot 
          project under this subsection shall not affect the eligibility 
          of such manufacturer to participate in any quarterly reporting 
          program implemented under this Act. The Secretary may determine 
          that, for the specified time period to be determined by the 
          Secretary, a manufacturer's participation in a pilot project 
          under this subsection may meet certain other requirements of 
          this section or section 522 if--
                      ``(A) the project has demonstrated success in 
                  capturing relevant adverse event information; and
                      ``(B) the Secretary has established procedures for 
                  making adverse event and safety information collected 
                  from the pilot public, to the extent possible, if 
                  collected pursuant to this section or section 522.
              ``(7) Privacy requirements.--With respect to the pilot 
          projects conducted pursuant to this subsection--
                      ``(A) individual identifiable health information 
                  shall not be disclosed when presenting any information 
                  from such project; and
                      ``(B) such projects shall comply with section 
                  264(c) of the Health Insurance Portability and 
                  Accountability Act of 1996 (42 U.S.C. 1320d-2 note) and 
                  sections 552 and 552a of title 5, United States Code.
              ``(8) Other compliance.--Any pilot program undertaken in 
          coordination with the comprehensive system described in 
          paragraph (1)(C), including pilot projects under this 
          subsection, that relates to the use of real world evidence for 
          devices shall comply with paragraph (1)(B), the conditions 
          listed in subparagraphs (A) and (B) of paragraph (3), and 
          paragraphs (4), (5), (6), and (7).
              ``(9) Sunset.--This subsection shall cease to have force or 
          effect on October 1, 2022.''.
      (b) Report.--Not later than January 31, 2021, the Secretary of 
  Health and Human Services, acting through the Commissioner of Food and 
  Drugs, shall conduct a review through an independent third party to 
  evaluate the strengths, limitations, and appropriate use of evidence 
  collected pursuant to real world evidence pilot projects described in 
  the letters described in section 201(b) of the Medical Device User Fee 
  Amendments of 2017 and subsection (i) of section 519 of the Federal 
  Food, Drug, and Cosmetic Act (21 U.S.C. 360i), as amended by subsection 
  (a), for informing premarket and postmarket decisionmaking for multiple 
  device types, and to determine whether the methods, systems, and 
  programs in such pilot projects efficiently generate reliable and 
  timely evidence about the effectiveness or safety surveillance of 
  devices.
target: Medical Device Safety Monitoring Act This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to support pilot projects in order to provide timely and reliable information on the safety and effectiveness of marketed medical devices. The projects must: (1) be designed to generate safety and active surveillance data, (2) inform support for safety and active surveillance activities, (3) be coordinated with a system for evaluating medical device technology that operates under a board with representation from consumer groups and device manufacturers, and (4) use electronic health data. The FDA may determine that a manufacturer's participation in a pilot project satisfies requirements regarding reporting or postmarket surveillance if the project captures adverse event information and the FDA has established procedures to publish safety information from the project. Not later than January 31, 2021, the FDA must evaluate real world evidence pilot projects, such as the ones supported by this bill, for their ability to inform decision-making and efficiently generate evidence about the safety or effectiveness of medical devices.
feat_title: Medical Device Safety Monitoring Act