[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[S. 870 Introduced in Senate (IS)]







105th CONGRESS
  1st Session
                                 S. 870

  To amend the Federal Food, Drug, and Cosmetic Act to facilitate the 
   development, approval, and use of medical devices to maintain and 
 improve the public health and quality of life of individuals, and for 
                            other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 10, 1997

 Mr. Wellstone introduced the following bill; which was read twice and 
         referred to the Committee on Labor and Human Resources

_______________________________________________________________________

                                 A BILL


 
  To amend the Federal Food, Drug, and Cosmetic Act to facilitate the 
   development, approval, and use of medical devices to maintain and 
 improve the public health and quality of life of individuals, and for 
                            other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE AND REFERENCE.

    (a) Short Title.--This Act may be cited as the ``Medical 
Technology, Public Health, and Innovation Act of 1997''.
    (b) Reference.--Whenever in this Act an amendment or repeal is 
expressed in terms of an amendment to, or a repeal of, a section or 
other provision, the reference shall be considered to be made to a 
section or other provision of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321 et seq.).

SEC. 2. FINDINGS; MISSIONS STATEMENT.

    (a) Findings.--The Congress finds the following:
            (1) While the United States appropriately puts a top 
        priority on the regulation of medical technologies to ensure 
        the safety and efficacy of medical technologies that are 
        introduced into the marketplace, the administration of such 
        regulatory effort is causing the United States to lose its 
        leadership role in producing innovative, top-quality medical 
        devices.
            (2) One of the key components of the medical device 
        regulatory process that contributes to the United States losing 
        its leadership role in medical device development is the 
        inordinate amount of time it takes for medical technologies to 
        be reviewed by the Food and Drug Administration.
            (3) The most important result of the United States losing 
        its leadership role is that patients in the United States do 
        not have access to new medical technology in a timely manner.
            (4) Delayed patient access to new medical technology 
        results in lost opportunities to save lives, to reduce 
        hospitalization and recovery time, and to improve the quality 
        of life of patients.
            (5) The economic benefits that the United States medical 
        device industry, which is composed principally of smaller 
        companies, has provided through growth in jobs and global trade 
        are threatened by the slow and unpredictable regulatory process 
        at the Food and Drug Administration.
            (6) The pace and predictability of the medical device 
        regulatory process are in part responsible for the increasing 
        tendency of United States medical device companies to shift 
        research, product development, and manufacturing offshore, at 
        the expense of American jobs, patients, and leading edge 
        clinical research.
    (b) Mission Statement.--This legislation seeks to improve the 
timeliness, effectiveness, and predictability of the medical device 
approval process for the benefit of United States patients and the 
United States economy by--
            (1) providing for the use of nationally and internationally 
        recognized performance standards to assist the Food and Drug 
        Administration in determining the safety and effectiveness of 
        medical devices;
            (2) facilitating communication between medical device 
        companies and the Food and Drug Administration;
            (3) targeting the use of Food and Drug Administration 
        resources on medical devices that are likely to have serious 
        adverse health consequences; and
            (4) requiring the Food and Drug Administration to determine 
        the least costly, most efficient approach to reasonably 
        assuring the safety and effectiveness of devices.

SEC. 3. DEVICE PERFORMANCE STANDARDS.

    (a) Alternative Procedure.--Section 514 (21 U.S.C. 360d) is amended 
by adding at the end the following:

                ``recognition of a performance standard

    ``(c)(1)(A) The Secretary may, through publication in the Federal 
Register, issue notices identifying and listing nationally and 
internationally recognized performance standards for which persons may 
provide a certification of a device's conformity under paragraph (3) in 
order to meet the premarket submission requirements or other 
requirements under the Act to which the standards are applicable.
    ``(B) Any person may elect to utilize data other than data required 
by the standards described in subparagraph (A) to meet any requirement 
under the Act to which the standards are applicable.
    ``(2) The Secretary may remove from the list of standards described 
in paragraph (1) a standard that the Secretary determines is no longer 
appropriate for making determinations with respect to the regulation of 
devices.
    ``(3)(A) A person may provide a certification that a device 
conforms to an applicable standard listed under paragraph (1) to meet 
the requirements described in paragraph (1) and the Secretary shall 
accept such certification.
    ``(B) The Secretary may, at any time, request a person who submits 
a certification described in subparagraph (A) to submit the data or 
information that the person relied on in making the certification.
    ``(C) A person who submits a certification described in 
subparagraph (A) shall maintain the data and information upon which the 
certification was made for a period of 2 years after the submission of 
the certification or a time equal to the expected design life of a 
device, whichever is longer.''.
    (b) Section 301.--Section 301 (21 U.S.C. 331) is amended by adding 
at the end the following:
    ``(x) The falsification of a certification submitted under section 
514(c)(3) or the failure or refusal to provide data or information 
requested by the Secretary under such section.''.
    (c) Section 501.--Section 501(e) (21 U.S.C. 351(e)) is amended by 
striking ``established'' and inserting ``established or listed''.

SEC. 4. PREMARKET APPROVAL.

    (a) Application.--Section 515(c) (21 U.S.C. 360e(c)) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (F), by striking ``; and'' and 
                inserting a semicolon;
                    (B) in subparagraph (G), by striking ``require.'' 
                and inserting ``require; and''; and
                    (C) by adding at the end the following:
            ``(H) an identifying reference to any performance standard 
        listed under section 514(c) that is applicable to such 
        device.''.
            (2) by adding at the end the following:
    ``(3) The Secretary shall accept historical clinical data as a 
control for use in determining whether there is a reasonable assurance 
of safety and effectiveness of a device in a case in which the effects 
of the progression of a disease are clearly defined and well 
understood.
    ``(4) The Secretary may not require the sponsor of an application 
to conduct clinical trials for a device using randomized controls 
unless the controls--
            ``(A) are necessary;
            ``(B) are scientifically and ethically feasible; and
            ``(C) other less burdensome and controls, such as 
        historical controls, are not available to permit a 
        determination of a reasonable assurance of safety and 
        effectiveness.''.
    (b) Action on Application.--Section 515(d) (21 U.S.C. 360e(d)) is 
amended--
            (1) in paragraph (1)(A)--
                    (A) by striking ``paragraph (2) of this 
                subsection'' each place it appears and inserting 
                ``paragraph (8)''; and
                    (B) by adding at the end the following flush 
                paragraph:
``In making a determination to approve or deny an application, the 
Secretary shall rely on the conditions of use proposed in the labeling 
of device as the basis for determining whether or not there is a 
reasonable assurance of safety and effectiveness. If, based on a fair 
evaluation of all material facts, the proposed labeling of the device 
is neither false nor misleading in any particular, the Secretary shall 
not consider conditions of use not included in such labeling in making 
the determination.'';
            (2) by redesignating paragraphs (2) and (3) as paragraphs 
        (8) and (9), respectively; and
            (3) by inserting after paragraph (1) the following:
    ``(2) Each application received under subsection (c) shall be 
reviewed in a manner to achieve final action within the 180-day period 
described in subparagraph (A), and the 180-day period may not be 
altered for any reason without the written consent of an applicant.
    ``(3)(A) Not later than 100 days after the receipt of an 
application that has been filed by the Secretary because the 
application satisfies the content requirements of subsection (c)(1), 
the Secretary shall meet with the applicant and disclose each 
deficiency relating to the application that would preclude approval of 
the application under paragraph (1).
    ``(B) The applicant shall have the right to be informed in writing 
with respect to the information communicated to the applicant during 
the meeting.
    ``(4) To permit better treatment or better diagnoses of life-
threatening or irreversibly debilitating diseases or conditions, the 
Secretary shall expedite the review for devices--
            ``(A) representing breakthrough technologies;
            ``(B) offering significant advantages over existing 
        approved alternatives; or
            ``(C) for which accelerated availability is in the best 
        interest of the public health.
    ``(5) The Secretary shall complete the review of all supplemental 
applicants to an application approved under paragraph (1) that do not 
contain clinical data within 90 days after the receipt of a 
supplemental that has been accepted for filing.''
    ``(6)(A) A supplemental application shall be required for any 
change to a device subject to an approved application under this 
subsection if the change affects safety or effectiveness, unless the 
change is a modification in a manufacturing procedures or method of 
manufacturing and the holder of an approved application submits a 
notice to the Secretary that describes the change and informs the 
Secretary that the change has been made under the requirements of 
section 520(f).
    ``(B)(i) In reviewing a supplement to an approved application for 
an incremental change to the design of a device that affects safety or 
effectiveness, the Secretary shall approve the supplement if--
            ``(I) nonclinical data demonstrate that a design 
        modification creates the intended additional capacity, 
        function, or performance of the device; and
            ``(II) clinical data from the approved application and any 
        supplements to the approved application provide a reasonable 
        assurance of safety and effectiveness.
    ``(ii) The Secretary may require, when necessary, additional 
clinical data to evaluate the design modification to provide a 
reasonable assurance of safety and effectiveness.
    ``(7) Any representation in promotional materials for a device 
subject to an approved application under this subsection shall not be 
subject to premarket approval under this section, unless such 
representations establish new conditions of use. Any representations 
made in promotional materials for devices subject to an approved 
application shall be supported by appropriate data or information that 
can substantiate the representations at the time such representations 
are made.''.
    (c) Withdrawal or Temporary Suspension of Approval of 
Application.--Section 5155(e)(1) (21 U.S.C. 360e(1)) is amended in 
subparagraph (G) by inserting after the word ``effect'' the words ``or 
listed.''

SEC. 5. PREMARKET NOTIFICATION.

    (a) Exemption of Certain Devices.--Section 510 (21 U.S.C. 360) is 
amended--
            (1) in subsection (k), by striking ``intended for human 
        use'' and inserting ``intended for human use (except a device 
        that is classified into class I under section 513 or 520 or a 
        device that is classified into class II under section 513 or 
        520, and is exempt from the requirements of this subsection 
        under subsection (l))'';
            (2) by adding at the end of subsection (k) (as amended by 
        paragraph (1)) the following flush sentence:
``The Secretary shall review the notification required by this 
subsection and make a determination under section 513(f)(1)(A) within 
90 days after receiving the notification.''; and
            (3) by adding at the end the following:
    ``(1)(A) Within 30 days after the date of enactment of this 
subsection, the Secretary shall develop and publish in the Federal 
Register a list of each type of class II device that does not require a 
report under subsection (k) to provide reasonable assurance of safety 
and effectiveness. Each type of class II device identified by the 
Secretary not to require the report shall be exempt from the 
requirement to file a report under subsection (k) as of the date of the 
publication of the list in the Federal Register.
    ``(B) Beginning on the date that is 1 day after the date of the 
publication of a list under this subsection, any person may petition 
the Secretary to exempt a type of class II device from the requirement 
of subsection (k). The Secretary shall respond to the petition within 
120 days after the receipt of the petition and determine whether or not 
to grant the petition in whole or in part.''.
    (b) Special Rule Relating to Exemption of Class I Devices From 
510(k) Notifications.--The exemption of a class I device from the 
notification requirement of section 510(k) shall not apply to a class I 
device that is life sustaining or life saving or that is intended to be 
implanted into the human body.

SEC. 6. INVESTIGATIONAL DEVICE EXEMPTION.

    (a) Regulations.--Section 520(g) (21 U.S.C. 360j(g)) is amended--
            (1) by redesignating paragraphs (4) and (5) as paragraphs 
        (5) and (6), respectively; and
            (2) by inserting after paragraph (3) the following:
    ``(4) The Secretary shall, within 120 days after the date of 
enactment of this paragraph, by regulation, amending the content of 
part 812 of title 21 of the Code of Federal Regulations, amend the 
procedures with respect to the approval of clinical studies under this 
subsection as follows:
            ``(A) The Secretary shall permit the sponsor of an 
        investigation to meet with the Secretary prior to the 
        submission of an application to develop a protocol for a 
        clinical study subject to the regulation and require that the 
        protocol be agreed upon in writing by the sponsor and the 
        Secretary.
            ``(B)(i) The Secretary shall permit developmental changes 
        to devices in response to information gathered during the 
        course of an investigation without requiring an additional 
        approval of an application for an investigational device 
        exemption, or the approval of a supplement to the application, 
        if the changes meet the following requirements:
                    ``(I) The changes do not constitute a significant 
                change in the design of the product or a significant 
                change in basic principles of operation.
                    ``(II) The changes do not adversely affect patient 
                safety.
            ``(ii) The Secretary shall require that each such change 
        shall be documented with information describing the change and 
        the basis of the sponsor of application for concluding that the 
        change does not constitute a significant change in design or 
        operating principles, and that the change does not adversely 
        affect patient safety.''.
    (b) Conforming Amendments.--Section 517(a)(7) (21 U.S.C. 
360g(a)(7)) is amended--
            (1) by striking ``section 520(g)(4)'' and inserting 
        ``section 520(g)(5)''; and
            (2) by striking ``section 520(g)(5)'' and inserting 
        ``section 520(g)(6)''.

SEC. 7 PRODUCT REVIEW.

    Section 513 (21 U.S.C. 360c) is amended by--
            (1) in subsection (a)(3)(A)--
                    (A) by striking ``including clinical investigations 
                where appropriate'' and inserting ``including 1 or more 
                clinical investigations where appropriate'';
                    (B) by adding at the end the following: ``When 
                evaluating the type and amount of data necessary to 
                find a reasonable assurance of device effectiveness for 
                an approval under section 515, the Secretary shall 
                consider the extent to which reliance on postmarket 
                controls may contribute to such assurance and expedite 
                effectiveness determinations without increasing 
                regulatory burdens on persons who submit applications 
                under section 515(c).'';
            (2) in subsection (a)(3), by adding at the end the 
        following:
    ``(C)(i) The Secretary upon the request of any person intending to 
submit an application under section 515 shall meet with the person to 
determine the type of valid scientific evidence within the meaning of 
subparagraphs (A) and (B) that will be necessary to demonstrate the 
effectiveness of a device for the conditions of use proposed by such 
person to support an approval of an application.
    ``(ii) Within 30 days after such meeting, the Secretary shall 
specify in writing the type of valid scientific evidence that will 
provide a reasonable assurance that a device is effective under the 
conditions of use proposed by the person.
    ``(iii) Any clinical data, including 1 or more well-controlled 
investigations, specified by the Secretary for demonstrating a 
reasonable assurance of device effectiveness shall reflect the 
Secretary's determination that such data are necessary to establish 
device effectiveness and that no other less burdensome means of 
evaluating device effectiveness are available which would have a 
reasonable likelihood of resulting in an approval.
    ``(2) The determination of the Secretary with respect to the 
specification of the valid scientific evidence under clause (ii) shall 
be binding upon the Secretary, unless such determination by the 
Secretary would be contrary to the public health''; and
            (3) in subsection (i), by adding at the end the following:
    ``(C) To facilitate reviews of reports submitted to the Secretary 
under section 510(k), the Secretary shall consider the extent to which 
reliance on postmarket controls may expedite the classification of 
devices under subsection (f)(1).
    ``(D) Whenever the Secretary requests information to demonstrate 
that devices with differing technological characteristics are 
substantially equivalent, the Secretary shall only request information 
that is necessary to making substantial equivalence determinations. In 
making such requests, the Secretary shall consider the least burdensome 
means of demonstrating substantial equivalence and request information 
accordingly.
    ``(E) Any determinations of substantial equivalence by the 
Secretary shall be based upon the intended uses proposed in labeling 
submitted in a report under section 510(k).
    ``(F) Any representations made in promotional materials for devices 
shall not require a report under section 510(k), unless such 
representations establish new intended uses for a legally marketed 
device.''.
                                 <all>