[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 1069 Introduced in Senate (IS)]

<DOC>






115th CONGRESS
  1st Session
                                S. 1069

  To establish pilot projects in order to provide timely and reliable 
  information on the safety and effectiveness of cleared or approved 
                                devices.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 8, 2017

  Mr. Casey (for himself, Ms. Warren, and Mr. Franken) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  To establish pilot projects in order to provide timely and reliable 
  information on the safety and effectiveness of cleared or approved 
                                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 ``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.
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