[Congressional Record Volume 141, Number 170 (Tuesday, October 31, 1995)]
[Senate]
[Pages S16422-S16425]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. WELLSTONE:
  S. 1369. 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 Resource.


   the medical technology, public health, and innovation act of 1995

  Mr. WELLSTONE. Mr. President, the legislation I am introducing today 
would take a significant and responsible step toward improving the 
effectiveness, timeliness, and predictability of the FDA review process 
for medical devices.
  Over the past 9 months, I have met with numerous representatives of 
Minnesota's medical device industry, patient advocacy groups, 
clinicians, and officials at 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.
  Two weeks ago I visited SpineTech, which is a perfect example of 
Minnesota's burgeoning, world-famous medical device industry. It was 
formed in 1991 with 4 people, funded by venture capital, and it now 
employs more than 40 people. It manufacturers a breakthrough disc 
replacement technology which has been studied in clinical trials for 3 
years. The technology, used for individuals with chronic low-back pain, 
has been shown to result in shorter hospital stays, less invasive 
surgery and lower medical costs than the alternative therapy.
  SpineTech filed its premarket approval application in January of this 
year. The application has not yet been accepted by the FDA and thus the 
premarket approval process has not yet even officially begun. The 
average total elapsed time for FDA review of PMA applications is now 
about 823 days. The technology has been available in every other 
advanced industrialized country for the past 2 years.
  The technologies that the FDA regulates are changing rapidly. We 
cannot afford a regulatory system 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 risk and rewards of streamlining 
all aspects of how FDA does its job--including the approval process for 
breakthrough products.
  The legislation that I will be introducing would begin to address 
these objectives 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 and promote 
global harmonization and interantional trade. 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 so important that I have even included what would 
usually be management decisions in the legislation. This bill includes 
provisions for periodic meetings betwen 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 device 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. 
Enabling the FDA to focus its attention where the real risks are will 
not only streamline the approval process but also benefit consumers and 
patients.
  Finally, I want to be clear that this legislation is a work in 
progress. I look forward to working with Senator Kassebaum, the 
chairman of the Labor and Human Resources Committee, and my colleagues 
on the committee on the concepts included in my proposal. I will work 
vigorously to ensure they are included in any comprehensive FDA 
legislation considered by the Senate both this year and in the future. 
I look forward to continuing to work on these issues with Minnesotans 
and to pressing ahead next year on whatever we cannot accomplish this 
year. Clearly there are actions Congress can take to improve the FDA 
without scarificing the assurances of safety that all Americans depend 
on.
  Mr. President, 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. 1369

       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 1995''.
       (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:

[[Page S16423]]

       (1) While the United States appropriately puts a top 
     priority on ensuring 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 United States 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 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, together with a perceived adversarial 
     relationship with the Food and Drug Administration, 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) redefining clinical testing requirements to reflect the 
     nature of device evolution; and
       (4) targeting the use of Food and Drug Administration 
     resources on those devices that are likely to have serious 
     adverse health consequences.

     SEC. 3. PERFORMANCE STANDARDS.

       Section 514 (21 U.S.C. 360d) is amended by adding at the 
     end thereof the following new subsection:


            ``establishment and adoption of other standards

       ``(c)(1) The Secretary--
       ``(A) may establish pursuant to subsection (b) performance 
     standards to assist in determining the safety or 
     effectiveness of class III devices under section 515; and
       ``(B) may amend or revoke the performance standards 
     established under subparagraph (A).
       ``(2) The Secretary shall, within 365 days of the date of 
     enactment of this subsection, adopt performance standards 
     established by nationally and internationally recognized 
     standard-setting entities and use the standards when 
     applicable to assist in determining the safety and 
     effectiveness of class III devices under section 515.
       ``(3) The Secretary may not require, as the condition for 
     approving a premarket approval application under section 515, 
     the conformity of a class III device with a performance 
     standard established or adopted pursuant to paragraph (1) or 
     (2), respectively, if the applicant submits data other than 
     that required by the performance standard to demonstrate a 
     reasonable assurance of the safety and effectiveness of the 
     device.
       ``(4) The Secretary, in lieu of requiring data 
     demonstrating the conformity of a class III device with a 
     standard described in paragraph (1) and (2), shall accept 
     certification by the applicant that the device conforms with 
     each standard identified in the application.
       ``(5) The Secretary may revoke the performance standards 
     adopted under paragraph (2).
       ``(6) A performance standard established under this 
     subsection for a device--
       ``(A) shall include provisions to provide reasonable 
     assurance of the safe and effective performance of the 
     device;
       ``(B) shall, where necessary to provide reasonable 
     assurance of the safe and effective performance of the 
     device, include--
       ``(i) provisions with respect to the construction, 
     components, ingredients, and properties of the device and the 
     compatibility of the device with power systems and 
     connections to the systems;
       ``(ii) provisions for the testing (on a sample basis or, if 
     necessary, on an individual basis) of the device or, if it is 
     determined that no other more practicable means are available 
     to the Secretary to assure the conformity of the device to 
     the standard, provisions for the testing (on sample basis or, 
     if necessary, on an individual basis) of the device by the 
     Secretary or by another person at the direction of the 
     Secretary;
       ``(iii) provisions for the measurement of the performance 
     characteristics of the device;
       ``(iv) provisions requiring that the results of each or 
     certain of the tests of the device required to be made under 
     clause (ii) demonstrate that the device is in conformity with 
     those portions of the standard for which the test or tests 
     were required; and
       ``(v) a provision requiring that the sale and distribution 
     of the device be restricted to the extent that the sale and 
     distribution of the device is restricted under a regulation 
     under section 520(e); and
       ``(C) shall, where appropriate, require the use and 
     prescribe the form and content of labeling for the proper 
     installation, maintenance, operation, and use of the 
     device.''.

     SEC. 4. PREMARKET APPROVAL.

       (a) Application.--Section 515(c) (21 U.S.C. 360e(c)) is 
     amended--
       (1) in paragraph (1)--
       (A) by striking subparagraph (D); and
       (B) by redesignating subparagraphs (E), (F), and (G) as 
     subparagraphs (D), (E), and (F), respectively; and
       (2) by adding at the end thereof the following new 
     paragraphs:
       ``(3)(A) An applicant--
       ``(i) shall include in an application described in 
     paragraph (1) an identifying reference to any applicable 
     performance standard established or adopted under paragraph 
     (1) or (2) of section 514(c), respectively; and
       ``(ii) shall include in the application--
       ``(I) a certification by the applicant as described in 
     section 514(c)(4), that the device complies with the 
     applicable performance standard; or
       ``(II) data to support the safety or effectiveness of the 
     device.
       ``(B)(i) Except as provided in clause (ii), the Secretary 
     may not require an applicant who submits an application for 
     premarket approval for a class III device under paragraph (1) 
     to submit preclinical data and information regarding the 
     device relevant to a performance standard established or 
     adopted under paragraph (1) or (2) of section 514(c), 
     respectively, if such standard defines performance or other 
     specifications for the device, and the applicant certifies 
     that the device conforms to the standard.
       ``(ii) The Secretary may require an applicant described in 
     clause (i) to submit preclinical data and information 
     regarding a class III device if additional information or 
     data are necessary to protect patient safety.
       ``(C) The Secretary shall require an applicant who 
     certifies that a device conforms to an applicable performance 
     standard established or adopted under paragraph (1) or (2) of 
     section 514(c), respectively to maintain data demonstrating 
     such conformance for a period of time that is equal to the 
     period of time for the design and expected life of the device 
     and to make the data available to the Secretary upon request.
       ``(D) The Secretary may deny, withdraw, or temporarily 
     suspend approval of a premarket approval application for a 
     class III device if--
       ``(i) the Secretary determines that the device does not 
     conform to an applicable performance standard (on which the 
     applicant relied) established or adopted under paragraph (1) 
     or (2) of section 514(c), respectively; and
       ``(ii) such conformance is considered by the Secretary to 
     be material in approving the device.
       ``(4) The Secretary shall accept retrospective or 
     historical clinical data as a control or for use in 
     determining whether there is a reasonable assurance of device 
     safety and effectiveness if the data are available and the 
     effects of the device on disease progression are clearly 
     defined and well understood.
       ``(5) The Secretary may not require the sponsor of an 
     application to conduct clinical trials for a device using 
     randomized controls unless--
       ``(A)(i) such controls are scientifically and ethically 
     feasible;
       ``(ii) the effects of the device on disease progression are 
     not clearly defined and well understood as determined by the 
     Secretary; and
       ``(iii) retrospective or historical data are not available 
     that meet the standards of the Secretary for quality and 
     completeness; or
       ``(B) such controls are necessary to support specific 
     marketing claims.
       ``(6) The Secretary may not require in a supplement to a 
     premarket approval application data from randomized clinical 
     trials for a modification to a device if--
       ``(A) the modification does not substantially and adversely 
     affect safety or effectiveness; and
       ``(B) the modified device has the same intended use and is 
     intended for similar patient populations as the approved 
     device.''.
       (b) Action on Application.--Section 515(d) (21 U.S.C. 
     360e(d)) is amended--
       (1) in paragraph (1)(A), by striking ``paragraph (2) of 
     this subsection'' each place it appears and inserting 
     ``paragraph (6)'';
       (2) by redesignating paragraphs (2) and (3) as paragraphs 
     (6) and (7), respectively; and
       (3) by inserting after paragraph (1) the following new 
     paragraphs:
       ``(2) Each premarket approval application and supplement 
     received by the Secretary under subsection (c) shall be 
     reviewed in the following manner to achieve final action on 
     the application within 180 days of the receipt of the 
     application:
       ``(A) The Secretary shall make a determination within 30 
     days of the receipt of an application filed under subsection 
     (c) of whether the application satisfies the content 
     requirements of paragraphs (1) and (3) of subsection (c) and 
     applicable regulations, and 

[[Page S16424]]

     the Secretary shall notify the applicant of the determination 
     and whether the application has been accepted or has not been 
     accepted for review for premarket approval. If the Secretary 
     fails to notify the applicant within the 30-day period that 
     the application is not sufficiently complete to permit a 
     substantive review, the application shall be considered as 
     filed by the Secretary.
       ``(B) The Secretary shall, within 45 days after the date of 
     the acceptance of an application for review under 
     subparagraph (A)--
       ``(i) provide the applicant the opportunity for a meeting 
     (or teleconference) with the Secretary to--
       ``(I) inform the applicant of the general progress and 
     status of the application;
       ``(II) advise the applicant of deficiencies in the 
     application that have not been communicated to the applicant.

     The applicant shall have the right to be informed in writing 
     with respect to the information communicated to the applicant 
     during the meeting or teleconference under subclauses (I) and 
     (II).
       ``(ii) determine whether an advisory panel should be 
     convened by the Secretary to review the application or to 
     consider an issue related to the application.
       ``(C) The Secretary shall, within 90 days after the date of 
     the acceptance of an application for review under 
     subparagraph (A) provide an applicant the opportunity for a 
     meeting (or teleconference) with the Secretary to--
       ``(i) inform the applicant of the general progress and 
     status of the application;
       ``(ii) review actions taken by the applicant to correct 
     deficiencies identified at the 45-day meeting described in 
     subparagraph (B);
       ``(iii) advise the applicant of the deficiencies in the 
     application that have not been communicated to the applicant; 
     and
       ``(iv) review the proposed labeling for the device.

     The applicant shall have the right to be informed in writing 
     with respect to the information communicated to the applicant 
     during the meeting or teleconference under clauses (i) 
     through (iv).
       ``(D)(i) When an advisory panel is convened under 
     subparagraph (B)(ii) to review an application or to consider 
     an issue related to the application, the Secretary shall 
     within 15 days after the close of the advisory panel meeting 
     provide the applicant the opportunity for a meeting (or 
     teleconference) with the Secretary to identify any remaining 
     issues with respect to the approval of the application.
       ``(ii) If an advisory panel is not convened under 
     subparagraph (B)(ii), the Secretary shall, within 120 days 
     after the date of the acceptance of an application for review 
     under subparagraph (A), provide the applicant the opportunity 
     for a meeting (or teleconference) with the Secretary to--
       ``(I) inform the applicant of the general progress and 
     status of the application;
       ``(II) review the actions taken to correct deficiencies 
     identified in the application at the 90-day meeting described 
     in subparagraph (C); and
       ``(III) advise the applicant of the deficiencies in the 
     application that have not been communicated to the applicant.
       ``(iii) The applicant shall have the right to be informed 
     in writing with respect to the information communicated to 
     the applicant during the meeting or teleconference under 
     clauses (i) and (ii).
       ``(E) The Secretary shall, within 150 days after the date 
     of the acceptance of an application for review under 
     subparagraph (A), notify the applicant of the decision of the 
     Secretary to approve or disapprove the application.
       ``(F) The Secretary shall exclude the time that an 
     applicant takes to respond to the Secretary's requests for 
     additional data or information in determining when the 45-
     day, 90-day, 120-day and 150-day periods described in 
     subparagraphs (B), (C), (D), and (E) expire.
       ``(3) 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.
       ``(4)(A) The Secretary shall annually publish a status 
     report on the premarket clearance or approval of applications 
     and other device submissions.
       ``(B) The report described in subparagraph (A) shall 
     include--
       ``(i) a specific statement from the Secretary concerning 
     the performance of the Food and Drug Administration in 
     reducing the backlog in the reviewing of applications for 
     premarket clearance or approval for a device and meeting 
     statutory time limitations applicable to the review of the 
     applications;
       ``(ii) with respect to devices, data (which shall be 
     provided by the Center for Devices and Radiological Health 
     and each division of the Office of Device Evaluation of the 
     Center for Devices and Radiological Health) on--
       ``(I) the number of premarket approval applications, 
     supplements, premarket notifications, and applications for 
     investigational device exemptions, not accepted for filing by 
     the Secretary;
       ``(II) the total time (beginning on the date of the filing 
     of an application and ending on the date of the clearance or 
     approval of the application) required to review the premarket 
     approval applications, supplements, premarket notifications, 
     and applications for investigational device exemptions;
       ``(III) the total time (excluding the time periods 
     permitted for an applicant to prepare and submit to the 
     Secretary responses or additional information or data 
     requested by the Secretary) as calculated by the Food and 
     Drug Administration to complete the review of each premarket 
     approval application, supplement, premarket notification, and 
     application for investigational device exemption;
       ``(IV) the number of adverse decisions made with respect to 
     the applications and supplements described in subclause (II);
       ``(V) the number of nonapprovable letters for device 
     submissions;
       ``(VI) the number of deficiency letters for device 
     submissions;
       ``(VII) the number of times applicants are required to 
     supply information during the review of an application or 
     supplement described in subclause (II); and
       ``(VIII) the performance of the actions described in 
     paragraph (2), including performance information with respect 
     to the number of premarket approval applications that were or 
     were not reviewed within the time limitations described in 
     such paragraph and the time necessary to carry out each of 
     the actions; and
       ``(iii) baseline data for the data described in subclauses 
     (I) through (VII) of clause (ii) for the preceding year.
       ``(5) The Secretary shall complete the review of all 
     premarket approval supplements that do not contain clinical 
     data within 90 days of the receipt of a supplement that has 
     been accepted for filing.''.
       (c) Elimination of Premarket Approval of Supplements.--The 
     Secretary of Health and Human Services shall eliminate 
     premarket approval of supplements that relate to 
     manufacturing and product changes of a device that can be 
     demonstrated through appropriate protocols or other methods 
     to not affect adversely the safety or effectiveness of a 
     device. The Secretary of Health and Human Services shall 
     require the manufacturer of a device to submit to the 
     Secretary of Health and Human Services any information relied 
     upon to support a device-related change that is not subject 
     to premarket approval of a supplement to an application 
     approved under section 515 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360e). The information shall be made 
     a part of the device master record. The information shall be 
     maintained for a period of time equal to the period of time 
     for the design and expected life of the device, but not less 
     than 2 years after the date of release of the device for 
     commercial distribution by the manufacturer.

     SEC. 5. PREMARKET NOTIFICATION REQUIREMENTS.

       (a) Exemption for Class I and II Devices.--Section 510 (21 
     U.S.C. 360) is amended by adding at the end thereof the 
     following new subsection:
       ``(l) Within 365 days of the date of enactment of this 
     section, the Secretary shall exempt from the notification 
     requirement under subsection (k) class I and II devices that 
     should not be subject to the notification requirement because 
     such notification is not necessary to provide a reasonable 
     assurance of the safety and effectiveness of the devices. 
     Prior to making such determination, the Secretary shall 
     provide an opportunity for notice and comment with respect to 
     the appropriateness of the exemption for the class I and 
     II devices.''.
       (b) Limitation on Notification.--
       (1) In general.--The Secretary of Health and Human Services 
     shall not enforce the requirement for additional 
     notifications under section 510(k) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360(k)) for a change or 
     modification to a device initially classified under section 
     513(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     360c(f)) that--
       (A) is other than a major change or a major modification in 
     the intended use;
       (B) is supported by nonclinical data or information, when 
     appropriate; and
       (C) can be shown to not adversely affect the safety and 
     effectiveness of the device.
       (2) Maintenance of notification data.--The Secretary of 
     Health and Human Services shall require the manufacturer of a 
     device to submit to the Secretary of Health and Human 
     Services all data and information relied upon to document 
     that a change or modification of a device described in 
     paragraph (1) does not require an additional notification 
     under section 510(k). The data and information shall be made 
     a part of the device master record. The data and information 
     shall be maintained for a period of time equal to the period 
     of time for the design and expected life of the device, but 
     not less than 2 years after the date of release of the device 
     for commercial distribution by the manufacturer.

     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 new 
     paragraph:
       ``(4) The Secretary shall, within 120 days of 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 studies under this subsection as follows:
       ``(A) The regulation shall include provisions that require 
     the Secretary to permit 

[[Page S16425]]

     the sponsor to meet with the Secretary prior to the 
     submission of an application to develop a protocol for a 
     study subject to the regulation, that require that the 
     protocol shall be agreed upon in writing by the sponsor and 
     the Secretary, and that set forth a time limitation for the 
     sponsor to conduct a followup of a study.
       ``(B) The regulation shall require the Secretary to permit 
     developmental changes in devices subject to the regulation 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.

     The regulation shall require that such a change be documented 
     in records the applicant is required to maintain with respect 
     to the investigational device exemption.
       ``(C) The regulation shall provide for the use of an 
     investigational device for diagnosis or treatment use under a 
     protocol or investigational device exemption if the following 
     requirements are met:
       ``(i) The device is intended to treat or diagnose a serious 
     or immediately life-threatening disease.
       ``(ii) There is no comparable or satisfactory device or 
     other therapy available to treat or diagnose that disease in 
     the intended patient population.
       ``(iii) The device is under investigation in a controlled 
     clinical trial under an investigational device exemption in 
     effect for the trial or all clinical trials for the device 
     have been completed.
       ``(iv) The sponsor of the controlled clinical trial is 
     actively pursuing marketing approval of the investigational 
     device with due diligence.
       ``(D) The regulation shall require the Secretary to consult 
     with advisory panels, which have the appropriate expertise, 
     with respect to the establishment of an appropriate time 
     limitation for the conduct of a followup study by the sponsor 
     of the study.
       (b) Conforming Amendments.--Section 517(a)(7) of the 
     Federal Food, Drug, and Cosmetic Act (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. ESTABLISHMENT OF A POLICY AND PERFORMANCE REVIEW 
                   PANEL.

       Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 901 et seq.) is amended by adding at the end thereof 
     the following new section:

     ``SEC. 906. POLICY AND PERFORMANCE REVIEW PANEL.

       ``(a) Establishment.--There is established a panel to be 
     known as the Food and Drug Policy and Performance Review 
     Panel (hereafter referred to in this section as the `Panel').
       ``(b) Membership.--The members of the Panel shall be 
     appointed by the Secretary in accordance with subsection 
     (d)(1) and shall include--
       ``(1) individuals with expertise in medical, scientific, 
     and health policy and regulatory issues;
       ``(2) representatives of industry, voluntary health 
     associations, and patient advocacy groups; and
       ``(3) representatives of the Food and Drug Administration.
       ``(c) Terms.--
       ``(1) In general.--Each member of the Panel shall serve for 
     a term of not more than 3 years and the terms of office of 
     such members shall be staggered.
       ``(2) Reappointment.--Each member of the Panel may be 
     reappointed, but may not serve more than 3 consecutive terms.
       ``(3) Vacancies.--Any vacancy in the Panel shall not affect 
     the powers of the Panel and shall be filled in the same 
     manner as the original appointment.
       ``(d) Organizational Structure.--
       ``(1) In general.--The Chairperson of the Panel shall 
     organize the Panel in a manner that will ensure that there is 
     a portion of the membership of the Panel monitoring the 
     activities of each Center within the Food and Drug 
     Administration. The membership of the Panel shall be composed 
     of individuals with expertise necessary to ensure appropriate 
     review of the performance of each Center.
       ``(2) Definition.--For the purposes of this section, the 
     term `Center' means the Center for Devices and Radiological 
     Health, Center for Drug Evaluation and Research, Center for 
     Biologics Evaluation and Research, Center for Food Safety and 
     Applied Nutrition, Center for Veterinary Medicine, and Center 
     for Toxicological Research.
       ``(e) Chairperson and Vice Chairperson.--The Secretary 
     shall select a Chairperson and Vice Chairperson from among 
     the members of the Panel.
       ``(f) Initial Meeting.--Not later than 30 days after the 
     date on which all members of the Panel have been appointed, 
     the Panel shall hold its first meeting.
       ``(g) Meetings.--The Panel shall meet at the call of the 
     Chairperson.
       ``(h) Quorum.--A majority of the members of the Panel shall 
     constitute a quorum, but a lesser number of members may hold 
     hearings.
       ``(i) Duties.--The Panel shall--
       ``(1) monitor the activities carried out by the Secretary 
     through the Commissioner of Food and Drugs;
       ``(2) review the performance of the Food and Drug 
     Administration to determine if the Food and Drug 
     Administration is carrying out its mission to protect and 
     promote the public health and is developing appropriate 
     policy and effective regulations to carry out its mission;
       ``(3) review the performance of each Center in accordance 
     with subsection (d)(1);
       ``(4) meet at least twice annually with appropriate 
     management officials of the Food and Drug Administration and 
     representatives of each Center;
       ``(5) participate in the development of agency guidelines; 
     and
       ``(6) seek to facilitate the international harmonization of 
     regulatory requirements, while ensuring that a product that 
     is subject to the provisions of this Act, and that is 
     marketed in the United States, is safe and effective.
       ``(j) Report.--The Panel shall annually prepare and submit 
     to the Committee on Commerce of the House of Representatives 
     and the Committee on Labor and Human Resources of the Senate 
     a report that evaluates the performance of the Food and Drug 
     Administration (including a description of the activities 
     that the Food and Drug Administration has successfully or 
     unsuccessfully carried out) and includes a recommendation on 
     the administrative modifications needed to improve such 
     performance.
       ``(k) Hearings.--The Panel may hold such hearings, sit and 
     act at such times and places, take such testimony, and 
     receive such evidence as the Panel considers advisable to 
     carry out the purposes of this Act.
       ``(l) Information From Federal Agencies.--The Panel may 
     secure directly from any Federal department or agency such 
     information as the Panel considers necessary to carry out the 
     provisions of this Act. Upon request of the Chairperson of 
     the Panel, the head of such department or agency shall 
     furnish such information to the Panel.
       ``(m) Postal Services.--The Panel may use the United States 
     mails in the same manner and under the same conditions as 
     other departments and agencies of the Federal Government.
       ``(n) Detail of Government Employees.--Any Federal 
     Government employee may be detailed to the Panel without 
     reimbursement, and such detail shall be without interruption 
     or loss of civil service status or privilege.
       ``(o) Procurement of Temporary and Intermittent Services.--
     The Chairperson of the Panel may procure temporary and 
     intermittent services under section 3109(b) of title 5, 
     United States Code, at rates for individuals which do not 
     exceed the daily equivalent of the annual rate of basic pay 
     prescribed for level V of the Executive Schedule under 
     section 5316 of such title.
       ``(p) Termination of the Panel.--The termination provisions 
     of section 14 of the Federal Advisory Committee Act (5 U.S.C. 
     App.) shall not apply to the Panel.''.
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