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

<DOC>





                                                       Calendar No. 426
114th CONGRESS
  2d 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, Mr. Franken, Mr. Kirk, Mr. Enzi, and Mr. 
  Alexander) introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

                             April 18, 2016

              Reported by Mr. Alexander, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 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,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``FDA Device Accountability 
Act of 2015''.</DELETED>

<DELETED>SEC. 2. ENSURING LEAST BURDENSOME MEANS OF EVALUATING 
              DEVICES.</DELETED>

<DELETED>    (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:</DELETED>
<DELETED>    ``(j) Training and Oversight of Least Burdensome 
Requirements.--</DELETED>
        <DELETED>    ``(1) Training and assessment.--The Secretary 
        shall--</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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--
        </DELETED>
                <DELETED>    ``(A) conduct an audit of the training 
                described in paragraph (1)(A);</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(D) within 30 calendar days of 
                completion of the audit, make such audit available--
                </DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(ii) on the Internet website of 
                        the Food and Drug Administration.''.</DELETED>
<DELETED>    (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:</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(C) Nothing in this paragraph alters the standards for 
premarket approval of a device.</DELETED>
<DELETED>    ``(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.''.</DELETED>
<DELETED>    (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:</DELETED>
        <DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 3. PERMITTING NON-LOCAL INSTITUTIONAL REVIEW 
              BOARDS.</DELETED>

<DELETED>    (a) In General.--Section 520 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360(j)) is amended--</DELETED>
        <DELETED>    (1) in subsection (g)(3)--</DELETED>
                <DELETED>    (A) by striking ``local'' each place it 
                appears; and</DELETED>
                <DELETED>    (B) in subparagraph (A)(i), by striking 
                ``which has been''; and</DELETED>
        <DELETED>    (2) in subsection (m)(4)--</DELETED>
                <DELETED>    (A) by striking ``local'' each place it 
                appears; and</DELETED>
                <DELETED>    (B) by amending subparagraph (A) to read 
                as follows:</DELETED>
        <DELETED>    ``(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''.</DELETED>
<DELETED>    (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).</DELETED>

<DELETED>SEC. 4. CLARIFYING CLIA WAIVER STUDY DESIGN GUIDANCE FOR IN 
              VITRO DIAGNOSTICS.</DELETED>

<DELETED>    (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--</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (2) includes guidance on the appropriate use of 
        comparable performance between a waived user and a moderately 
        complex laboratory user to demonstrate accuracy.</DELETED>
<DELETED>    (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.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``FDA Device Accountability Act of 
2016''.

SEC. 2. USE OF NONLOCAL INSTITUTIONAL REVIEW BOARDS FOR REVIEW OF 
              INVESTIGATIONAL DEVICE EXEMPTIONS AND HUMAN DEVICE 
              EXEMPTIONS.

    Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j) is amended--
            (1) in subsection (g)(3)--
                    (A) in subparagraph (A)(i)--
                            (i) by striking ``local''; and
                            (ii) by striking ``which has been''; and
                    (B) in subparagraph (B), by striking ``a local 
                institutional'' and inserting ``an institutional''; and
            (2) in subsection (m)(4)--
                    (A) by striking subparagraph (A) and inserting the 
                following new subparagraph:
                    ``(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) in subparagraph (B), by striking ``a local 
                institutional'' and inserting ``an institutional''; and
                    (C) in the matter following subparagraph (B), by 
                striking ``local''.

SEC. 3. 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, acting through the Commissioner of Food and Drugs, 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 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, acting through the Commissioner of Food and Drugs, shall 
finalize the draft guidance published under subsection (a) not later 
than 1 year after the comment period for such draft guidance closes.

SEC. 4. 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 18 months after the 
        date of enactment of the FDA Device Accountability Act of 2016, 
        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), including the effectiveness of such 
                training in implementing the least burdensome 
                requirements;
                    ``(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 decisionmaking;
                    ``(C) include in such audit a list of the 
                measurement tools the Secretary uses to assess the 
                implementation of the least burdensome requirements, 
                including those referenced in paragraph (1)(B) and 
                section 517A(a)(3), and may also provide feedback on 
                the effectiveness of such tools in the implementation 
                of the least burdensome requirements;
                    ``(D) summarize the findings of such audit in a 
                final audit report; and
                    ``(E) within 30 calendar days of completion of such 
                final audit report, make such final audit report 
                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) For purposes of this paragraph, the Secretary 
                shall consider the role of postmarket information in 
                determining the least burdensome means of demonstrating 
                a reasonable assurance of device safety and 
                effectiveness.
                    ``(D) Nothing in this paragraph may alter the 
                standards for premarket approval of a device.''.
    (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 a brief statement regarding how the least burdensome 
        requirements were considered and applied consistent with 
        section 513(i)(1)(D), section 513(a)(3)(D), and section 
        515(c)(5), as applicable.''.
                                                       Calendar No. 426

114th CONGRESS

  2d Session

                                S. 1622

_______________________________________________________________________

                                 A BILL

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

_______________________________________________________________________

                             April 18, 2016

                       Reported with an amendment