[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1622 Introduced in Senate (IS)]

114th CONGRESS
  1st Session
                                S. 1622

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
                                devices.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 18, 2015

 Mr. Burr (for himself 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 amend the Federal Food, Drug, and Cosmetic Act with respect to 
                                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 ``FDA Device Accountability Act of 
2015''.

SEC. 2. ENSURING LEAST BURDENSOME MEANS OF EVALUATING DEVICES.

    (a) Training and Oversight of Least Burdensome Requirements.--
Section 513 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360c) is amended by adding at the end the following:
    ``(j) Training and Oversight of Least Burdensome Requirements.--
            ``(1) Training and assessment.--The Secretary shall--
                    ``(A) ensure that each employee of the Food and 
                Drug Administration who is involved in the review of 
                premarket submissions, including supervisors, receives 
                training regarding the meaning and implementation of 
                the least burdensome requirements under subsections 
                (a)(3)(D) and (i)(1)(D) and section 515(c)(5); and
                    ``(B) periodically assess the implementation of the 
                least burdensome requirements, including the employee 
                training under subparagraph (A) to ensure that the 
                least burdensome requirements are fully and 
                consistently applied.
            ``(2) Ombudsman audit.--Not later than 180 calendar days 
        after the date of enactment of the FDA Device Accountability 
        Act of 2015, the ombudsman for any organizational unit of the 
        Food and Drug Administration responsible for the premarket 
        review of devices shall--
                    ``(A) conduct an audit of the training described in 
                paragraph (1)(A);
                    ``(B) include in such audit interviews of persons 
                who are representatives of the device industry 
                regarding their experience in the device premarket 
                review process, including with respect to the 
                application of least burdensome concepts to premarket 
                review and the application of postmarket requirements 
                to facilitate premarket decisionmaking;
                    ``(C) include in such audit an assessment of the 
                measurement tools the Secretary uses to assess the 
                implementation of the least burdensome requirements, 
                including the effectiveness of such tools and the 
                effectiveness of the implementation of the least 
                burdensome requirements; and
                    ``(D) within 30 calendar days of completion of the 
                audit, make such audit available--
                            ``(i) to the Committee on Health, 
                        Education, Labor, and Pensions of the Senate 
                        and the Committee on Energy and Commerce of the 
                        House of Representatives; and
                            ``(ii) on the Internet website of the Food 
                        and Drug Administration.''.
    (b) Premarket Applications.--Section 515(c) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360e(c)) is amended by adding at the 
end the following:
    ``(5)(A) In requesting additional information with respect to an 
application under this section, the Secretary shall consider the least 
burdensome appropriate means necessary to demonstrate a reasonable 
assurance of device safety and effectiveness.
    ``(B) For purposes of subparagraph (A) the term `necessary' means 
the minimum required information that would support a determination by 
the Secretary that an application provides a reasonable assurance of 
the safety and effectiveness of the device.
    ``(C) Nothing in this paragraph alters the standards for premarket 
approval of a device.
    ``(D) For purposes of this paragraph, the Secretary shall consider 
whether the least burdensome means of demonstrating a reasonable 
assurance of device safety and effectiveness would be achieved through 
reliance on postmarket information.''.
    (c) Rationale for Significant Decisions Regarding Devices.--Section 
517A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g-
1(a)) is amended by adding at the end the following:
            ``(3) Application of least burdensome requirements.--The 
        substantive summary required under this subsection shall 
        include an explanation of how the least burdensome requirements 
        were considered and applied consistent with section 
        513(i)(1)(D) and section 513(a)(3)(D) and section 515(c)(5), as 
        applicable.''.

SEC. 3. PERMITTING NON-LOCAL INSTITUTIONAL REVIEW BOARDS.

    (a) In General.--Section 520 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(j)) is amended--
            (1) in subsection (g)(3)--
                    (A) by striking ``local'' each place it appears; 
                and
                    (B) in subparagraph (A)(i), by striking ``which has 
                been''; and
            (2) in subsection (m)(4)--
                    (A) by striking ``local'' each place it appears; 
                and
                    (B) by amending subparagraph (A) to read as 
                follows:
            ``(A) in facilities in which clinical testing of devices is 
        supervised by an institutional review committee established in 
        accordance with the regulations of the Secretary; and''.
    (b) Regulations.--Not later than 1 year after the date of the 
enactment of this Act, the Secretary of Health and Human Services shall 
revise or issue such regulations or guidance as may be necessary to 
carry out the amendments made by subsection (a).

SEC. 4. CLARIFYING CLIA WAIVER STUDY DESIGN GUIDANCE FOR IN VITRO 
              DIAGNOSTICS.

    (a) Draft Revised Guidance.--Not later than 1 year after the date 
of the enactment of this Act, the Secretary of Health and Human 
Services shall publish a draft guidance that--
            (1) revises section ``V. Demonstrating Insignificant Risk 
        of an Erroneous Result'' - ``Accuracy'' of the guidance 
        entitled ``Recommendations for Clinical Laboratory Improvement 
        Amendments of 1988 (CLIA) Waiver Applications for Manufacturers 
        of In Vitro Diagnostic Devices'' and dated January 30, 2008; 
        and
            (2) includes guidance on the appropriate use of comparable 
        performance between a waived user and a moderately complex 
        laboratory user to demonstrate accuracy.
    (b) Final Revised Guidance.--The Secretary of Health and Human 
Services shall finalize the draft guidance published under subsection 
(a) not later than 1 year after the comment period for such draft 
guidance closes.
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