[Congressional Record Volume 143, Number 80 (Tuesday, June 10, 1997)]
[Senate]
[Pages S5460-S5463]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. WELLSTONE:
  S. 870. 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; to the Committee on Labor and 
Human Resources.


   THE MEDICAL TECHNOLOGY, PUBLIC HEALTH, AND INNOVATION ACT OF 1997

  Mr. WELLSTONE. Mr. President, the legislation that I am introducing 
today, the Medical Technology, Public Health and Innovation Act of 
1997, takes a significant step toward improving the effectiveness, 
timeliness, and predictability of the FDA review process for medical 
devices.
  It is important that we improve the system for device approval in 
order to provide access to optimal technology to American consumers. We 
need to do this in order to promote the public health. We must also 
maintain protections for consumers, which are provided by the FDA's 
oversight of device manufacturing, development, and marketing. This 
legislation maintains those protections, while allowing for new 
efficiencies within the FDA.
  Over the past 2 years, I have met with numerous representatives of 
Minnesota's medical device industry, patient advocates, clinicians, and 
officials from the FDA, and have concluded that there are indeed steps 
that Congress should take to make the regulatory process for medical 
devices more efficient. Minnesotans want the FDA not only to protect 
public health, but also to promote public health. They want to know not 
only that new technologies will be safe, but that they will be 
available to them in a timely manner. Many of Minnesota's medical 
device manufacturers, researchers, clinicians, and patients in need of 
new and improved health care technology have become increasingly 
concerned about the regulatory environment at the FDA. While there have 
been some improvements in the device review process, there is still a 
need to increase communication between the FDA and industry; to 
decrease review times; and to have consistency in the review process.
  These needs are highlighted by the following example. A plant 
operated by a Minnesota-based device company was developing a new 
treatment for aortic aneurysms, which would require less invasive 
measures than are currently used. The company developed a protocol for 
testing its product, submitted the protocol to the FDA and was told by 
the reviewer that the protocol was invalid. The reviewer suggested a 
different protocol and the company followed it. Upon completion of the 
clinical trial, the company submitted the required data to the FDA. The 
original reviewer was on an extended leave of absence, so the data went 
to a different reviewer. The new reviewer deemed the protocol that was 
used to be invalid, and requested a new clinical trial, which basically 
followed the protocol that had been rejected by the first reviewer. The 
company was forced to do a new trial, which resulted in significant 
delays in getting this important product to market for patient use. I 
am certain that this is but one of many examples of inconsistently 
applied processes that delay the release of life-saving technology 
to the consumer.

  The technologies that the FDA regulates are changing rapidly. We 
cannot afford a regulatory system that is ill-equipped to speed these 
advances. As a result, both Congress and the Administration are 
reexamining the paradigms that have governed the FDA. Our challenge 
will be to define FDA's mission and scope of responsibility, as well as 
to give guidance on an appropriate balance between the risks and 
rewards of streamlining all aspects of how FDA does its job--including 
the approval process for breakthrough products.
  The legislation that I am introducing would begin to address these 
issues in three important ways:
  First, it would enable the FDA to adopt nationally and 
internationally recognized performance standards to improve the 
transparency and effectiveness of the device review process.

[[Page S5461]]

 Resource constraints and the time-consuming rulemaking process have 
precluded FDA promulgation of performance standards in the past. This 
legislation would allow the FDA, when appropriate, to simply adopt 
consensus standards that are already being used by most of the world 
and use those standards to assist in determining the safety and 
effectiveness of class III medical devices. The FDA could require 
additional data from a manufacturer relevant to an aspect of a device 
covered by an adopted performance standard if necessary to protect 
patient safety. Currently, the lack of clear performance standards for 
class III medical devices is a barrier to the improvement of the 
quality and timeliness of the premarket approval process.
  Second, it would improve communication between the industry and the 
FDA and the predictability of the review process. I believe that these 
two factors are extremely important. The bill includes provisions for 
meetings between the applicant and the FDA to ensure that applicants 
are promptly informed of any deficiencies in their application, that 
questions that can be answered easily would be addressed right away, 
and that applicants would be well informed about the status of their 
application. I believe that improving communication between the FDA and 
industry would result in greater compliance with regulations and that 
this will ultimately benefit consumers and patients.
  Third, the legislation would help the FDA focus its resources more 
appropriately. PMA supplements or 510(k)'s that relate only to changes 
that can be shown to not adversely affect the safety or effectiveness 
of the device would not require premarket approval or notification. 
Manufacturers would instead make information and data supporting the 
change part of the master record at the FDA. In addition the FDA would 
be able to exempt from premarket notification requirements those class 
II devices for which such requirements are unnecessary to ensure the 
public health without first having to go through the time consuming and 
bureaucratic process of reclassifying them to class I. The FDA would 
also have the option of relying on postmarket controls classifying 
devices. Enabling the FDA to focus its attention where the real risks 
are will not only streamline the approval process but also benefit 
consumers.
  I look forward to working with Senator Jeffords, the chairman of the 
Labor and Human Resources Committee, and my other colleagues on the 
Committee on the concepts included in my proposal. I will work 
vigorously to ensure that they are included in FDA legislation 
considered by the Senate this year. I look forward to continuing to 
work on these issues with Minnesotans. Clearly, there are actions that 
Congress can take to improve the FDA without sacrificing the assurance 
of safety that all Americans depend on.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                 S. 870

       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 provisions 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 of 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, 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)--
       (B) in subparagraph (F), by striking ``; and'' and 
     inserting a semicolon;
       (C) in subparagraph (G), by striking ``require.'' and 
     inserting ``require; and''; and
       (D) 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 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. 
     30e(d)) is amended--

[[Page S5462]]

       (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.'';
       (3) 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 supplement 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 procedure 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 515(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 of 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 510K 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).

[[Page S5463]]

       ``(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.''.
                                 ______