[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2737 Introduced in Senate (IS)]

<DOC>






114th CONGRESS
  2d Session
                                S. 2737

                 To improve medical device innovation.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 17, 2016

 Ms. Klobuchar (for herself and Mr. Roberts) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
                 To improve medical device innovation.

    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 ``Improving Medical Device Innovation 
Act''.

SEC. 2. RECOGNITION OF STANDARDS.

    (a) In General.--Section 514(c) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360d(c)) is amended--
            (1) in paragraph (1), by inserting after subparagraph (B) 
        the following new subparagraphs:
                    ``(C)(i) Any person may submit a request for 
                recognition under subparagraph (A) of all or part of an 
                appropriate standard established by a nationally or 
                internationally recognized standard organization.
                    ``(ii) Not later than 60 calendar days after the 
                Secretary receives such a request, the Secretary 
                shall--
                            ``(I) make a determination to recognize 
                        all, part, or none of the standard that is the 
                        subject of the request; and
                            ``(II) issue to the person who submitted 
                        such request a response in writing that states 
                        the Secretary's rationale for that 
                        determination, including the scientific, 
                        technical, regulatory, or other basis for such 
                        determination.
                    ``(iii) The Secretary shall take such actions as 
                may be necessary to implement all or part of a standard 
                recognized under subclause (I) of clause (ii), in 
                accordance with subparagraph (A).
                    ``(D) The Secretary shall make publicly available, 
                in such manner as the Secretary determines appropriate, 
                the rationale for recognition of all, part, or none of 
                a standard, including the scientific, technical, 
                regulatory, or other basis for the decision regarding 
                such recognition.''; and
            (2) by adding at the end the following:
            ``(4) Training on use of standards.--The Secretary shall 
        provide to all employees of the Food and Drug Administration 
        who review premarket submissions for devices periodic training 
        on the concept and use of recognized standards for purposes of 
        meeting a premarket submission requirement or other applicable 
        requirement under this Act, including standards relevant to an 
        employee's area of device review.''.
    (b) Guidance.--The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall review and update, if 
necessary, previously published guidance and standard operating 
procedures identifying the principles for recognizing standards, and 
for withdrawing the recognition of standards, under section 514(c) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)), taking 
into account the experience with and reliance on a standard by foreign 
regulatory authorities and the device industry, and whether recognition 
of a standard will promote harmonization among regulatory authorities 
in the regulation of devices.

SEC. 3. CERTAIN CLASS I AND CLASS II DEVICES.

    (a) Class I Devices.--Section 510(l) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(l)) is amended--
            (1) by striking ``A report under subsection (k)'' and 
        inserting ``(1) A report under subsection (k)''; and
            (2) by adding at the end the following new paragraph:
            ``(2) Not later than 120 calendar days after the date of 
        enactment of the Improving Medical Device Innovation Act and at 
        least once every 5 years thereafter, as the Secretary 
        determines appropriate, the Secretary shall identify, through 
        publication in the Federal Register, any type of class I device 
        that the Secretary determines no longer requires a report under 
        subsection (k) to provide reasonable assurance of safety and 
        effectiveness. Upon such publication--
                    ``(A) each type of class I device so identified 
                shall be exempt from the requirement for a report under 
                subsection (k); and
                    ``(B) the classification regulation applicable to 
                each such type of device shall be deemed amended to 
                incorporate such exemption.''.
    (b) Class II Devices.--Section 510(m) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360(m)) is amended--
            (1) by striking paragraph (1) and inserting the following 
        new paragraph:
            ``(1) The Secretary shall--
                    ``(A) not later than 90 days after the date of 
                enactment of the Improving Medical Device Innovation 
                Act and at least once every 5 years thereafter, as the 
                Secretary determines appropriate--
                            ``(i) publish in the Federal Register a 
                        notice that contains a list of each type of 
                        class II device that the Secretary determines 
                        no longer requires a report under subsection 
                        (k) to provide reasonable assurance of safety 
                        and effectiveness; and
                            ``(ii) provide for a period of not less 
                        than 60 calendar days for public comment 
                        beginning on the date of the publication of 
                        such notice; and
                    ``(B) not later than 210 calendar days after the 
                date of enactment of the Improving Medical Device 
                Innovation Act, publish in the Federal Register a list 
                representing the Secretary's final determination with 
                respect to the devices contained in the list published 
                under subparagraph (A).''; and
            (2) in paragraph (2)--
                    (A) by striking ``1 day after the date of 
                publication of a list under this subsection,'' and 
                inserting ``1 calendar day after the date of 
                publication of the final list under paragraph 
                (1)(B),''; and
                    (B) by striking ``30-day period'' and inserting 
                ``60-calendar-day period''; and
                    (C) by adding at the end the following new 
                paragraph:
            ``(3) Upon the publication of the final list under 
        paragraph (1)(B)--
                    ``(A) each type of class II device so listed shall 
                be exempt from the requirement for a report under 
                subsection (k); and
                    ``(B) the classification regulation applicable to 
                each such type of device shall be deemed amended to 
                incorporate such exemption.''.

SEC. 4. CLASSIFICATION PANELS.

    (a) Classification Panels.--Paragraph (5) of section 513(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended--
            (1) by striking ``(5)'' and inserting ``(5)(A)''; and
            (2) by adding at the end the following:
                    ``(B) When a device is specifically the subject of 
                review by a classification panel, the Secretary shall--
                            ``(i) ensure that adequate expertise is 
                        represented on the classification panel to 
                        assess--
                                    ``(I) the disease or condition 
                                which the device is intended to cure, 
                                treat, mitigate, prevent, or diagnose; 
                                and
                                    ``(II) the technology of the 
                                device; and
                            ``(ii) provide an opportunity for the 
                        person whose device is specifically the subject 
                        of panel review to provide recommendations on 
                        the expertise needed among the voting members 
                        of the panel.
                    ``(C) For purposes of subparagraph (B)(i), the term 
                `adequate expertise' means that the membership of the 
                classification panel includes--
                            ``(i) two or more voting members, with a 
                        specialty or other expertise clinically 
                        relevant to the device under review; and
                            ``(ii) at least one voting member who is 
                        knowledgeable about the technology of the 
                        device.
                    ``(D) The Secretary shall provide an annual 
                opportunity for patients, representatives of patients, 
                and sponsors of medical device submissions to provide 
                recommendations for individuals with appropriate 
                expertise to fill voting member positions on 
                classification panels.''.
    (b) Panel Review Process.--Section 513(b)(6) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360c(b)(6)) is amended--
            (1) in subparagraph (A)(iii), by inserting before the 
        period at the end ``, including by designating a representative 
        who will be provided a time during the panel meeting to address 
        the panel individually (or accompanied by experts selected by 
        such representative) for the purpose of correcting 
        misstatements of fact or providing clarifying information, 
        subject to the discretion of the panel chairperson''; and
            (2) by striking subparagraph (B) and inserting the 
        following new subparagraph:
                    ``(B)(i) Any meeting of a classification panel with 
                respect to the review of a device shall--
                            ``(I) provide adequate time for initial 
                        presentations by the person whose device is 
                        specifically the subject of such review and by 
                        the Secretary; and
                            ``(II) provide adequate time for and 
                        encourage free and open participation by all 
                        interested persons.
                    ``(ii) Following the initial presentations 
                described in clause (i), the panel may--
                            ``(I) pose questions to the designated 
                        representative described in subparagraph 
                        (A)(iii); and
                            ``(II) consider the responses to such 
                        questions in the panel's review of the 
                        device.''.

SEC. 5. POSTMARKET PILOT TO IMPROVE MEDICAL DEVICE REPORTING.

    (a) Pilot Projects.--
            (1) In general.--In order to improve the value and 
        efficiency of reporting so as to advance the objectives of 
        section 519(a) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 360i(a)), within one year of the date of enactment of 
        this Act, the Secretary of Health and Human Services shall 
        establish one or more pilot projects, in coordination with 
        device manufacturers, to explore and evaluate the use of 
        alternative methods of compliance with such subsection for 
        manufacturers of devices described in section 513(a)(1)(C) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        360c(a)(1)(C)).
            (2) Voluntary participation.--Participation in such pilot 
        projects shall be voluntary for device manufacturers. The 
        Secretary may establish the conditions for such voluntary 
        participation and may establish a process for authorizing 
        participation.
            (3) Purposes.--The pilot projects established under 
        paragraph (1) shall be designed to--
                    (A) test methods of reporting for one or more 
                device types, with priority given to devices for which 
                device manufacturers submit a relatively high volume of 
                reports under the regulations implementing section 
                519(a) of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 360i(a));
                    (B) evaluate forms of data monitoring and reporting 
                that improve the usability of report data by focusing 
                on events and information that are most relevant to 
                reasonably assuring the safety and effectiveness of the 
                device;
                    (C) identify methods of reporting that will be 
                least burdensome for device manufacturers; and
                    (D) evaluate methods that are alternative to, and 
                do not duplicate, compliance with requirements of part 
                803 of title 21, Code of Federal Regulations (or 
                successor regulations).
            (4) Notification to congress.--The Secretary of Health and 
        Human Services shall notify the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives not later than 18 
        months after the date of enactment of this Act of the number of 
        manufacturers that have agreed to participate in a pilot 
        project under this subsection with the Secretary of Health and 
        Human Services.
            (5) Rule of construction.--Nothing in this subsection shall 
        limit the authority of the Secretary of Health and Human 
        Services to provide for alternative methods of medical device 
        reporting under part 803 of title 21, Code of Federal 
        Regulations (or successor regulations), including such methods 
        described in this subsection.
            (6) Compliance with requirements for records or reports on 
        devices.--
                    (A) In general.--A device manufacturer that 
                participates in a pilot project under this subsection 
                shall be required to comply with all applicable 
                provisions of section 519 of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 360i), and implementing 
                regulations, except as described in subparagraph (B).
                    (B) Conditional exemption.--The Secretary may 
                determine that, for a specified time period to be 
                determined by the Secretary, a manufacturer 
                participating in a pilot project under this subsection 
                is exempt from certain provisions of section 519(a) of 
                the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                360i(a)), and implementing regulations, if such 
                manufacturer complies with the conditions set forth in 
                a pilot project under this subsection.
    (b) GAO Review.--
            (1) Review of pilot projects.--The Comptroller General of 
        the United States shall conduct a review of the pilot projects 
        established under subsection (a), and of the reporting system 
        under part 803 of title 21, Code of Federal Regulations (or 
        successor regulations).
            (2) Report.--Not later than January 31, 2021, the 
        Comptroller General of the United States shall submit to 
        Congress a report containing the results of the review 
        described in paragraph (1). Such report shall analyze the 
        value, efficiency, and effectiveness of reporting methods under 
        subsections (a) and (b) of section 519 of Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 360i) and identify any 
        recommendations for statutory amendments that would enhance the 
        objectives of section 519(a) of such Act.
                                 <all>