[House Report 105-307]
[From the U.S. Government Publishing Office]



105th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES

 1st Session                                                    105-307
_______________________________________________________________________


 
          MEDICAL DEVICE REGULATORY MODERNIZATION ACT OF 1997
                                _______
                                

October 6, 1997.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

  Mr. Bliley, from the Committee on Commerce, submitted the following

                              R E P O R T

                             together with

                            ADDITIONAL VIEWS

                        [To accompany H.R. 1710]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Commerce, to whom was referred the bill 
(H.R. 1710) to amend the Federal Food, Drug, and Cosmetic Act 
to facilitate the development, clearance, and use of devices to 
maintain and improve the public health and quality of life of 
the citizens of the United States, having considered the same, 
report favorably thereon with an amendment and recommend that 
the bill as amended do pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     2
Purpose and Summary..............................................    13
Background and Need for Legislation..............................    13
Hearings.........................................................    15
Committee Consideration..........................................    15
Rollcall Votes...................................................    15
Committee Oversight Findings.....................................    16
Committee on Government Reform and Oversight.....................    16
New Budget Authority and Tax Expenditures........................    16
Committee Cost Estimate..........................................    16
Congressional Budget Office Estimate.............................    16
Federal Mandates Statement.......................................    19
Advisory Committee Statement.....................................    19
Constitutional Authority Statement...............................    19
Applicability to Legislative Branch..............................    19
Section-by-Section Analysis of the Legislation...................    19
Changes in Existing Law Made by the Bill, As Reported............    34
Additional Views.................................................    57

    The amendment is as follows:
    Strike out all after the enacting clause and insert in lieu 
thereof the following:

SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CONTENTS.

  (a) Short Title.--This Act may be cited as the ``Medical Device 
Regulatory Modernization Act of 1997''.
  (b) Reference.--Whenever in this Act an amendment or repeal is 
expressed in terms of an amendment to, or repeal of, a section or other 
provision, the reference shall be considered to be made to that section 
or other provision of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321 et seq.).
  (c) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; references; table of contents.
Sec. 2. FDA mission and annual report.
Sec. 3. Dispute resolution.
Sec. 4. Investigational device exemptions; expanded access.
Sec. 5. Special review for certain devices.
Sec. 6. Expanding humanitarian use of devices.
Sec. 7. Device standards.
Sec. 8. Scope of review.
Sec. 9. Premarket notification.
Sec. 10. Classification panels.
Sec. 11. Premarket approval.
Sec. 12. Accreditation for accredited persons.
Sec. 13. Preamendment devices.
Sec. 14. Device tracking.
Sec. 15. Postmarket surveillance.
Sec. 16. Harmonization.
Sec. 17. Reports.
Sec. 18. Information system.
Sec. 19. Practice of medicine.
Sec. 20. Clarification of definition.
Sec. 21. Labeling and advertising regarding compliance with statutory 
requirements.
Sec. 22. Noninvasive blood glucose meter.
Sec. 23. Rule of construction.

SEC. 2. FDA MISSION AND ANNUAL REPORT.

  (a) Mission.--Section 903 (21 U.S.C. 393) is amended by redesignating 
subsections (b) and (c) as subsections (c) and (d), respectively, and 
by adding after subsection (a) the following:
  ``(b) Mission.--The Food and Drug Administration shall promote the 
public health by promptly and efficiently reviewing clinical research 
and taking appropriate action on the marketing of regulated products in 
a timely manner, and with respect to such products shall protect the 
public health by ensuring that--
          ``(1) foods are safe, wholesome, sanitary, and properly 
        labeled;
          ``(2) human and veterinary drugs are safe and effective;
          ``(3) there is reasonable assurance of safety and 
        effectiveness of devices intended for human use;
          ``(4) cosmetics are safe and properly labeled; and
          ``(5) public health and safety are protected from electronic 
        product radiation.
The Food and Drug Administration shall participate with other countries 
to reduce the burden of regulation, harmonize regulatory requirements, 
and achieve appropriate reciprocal arrangements.''.
  (b) Annual Report.--Section 903 (21 U.S.C. 393), as amended by 
subsection (a), is amended by adding at the end the following:
  ``(e) Annual Report.--The Secretary shall, simultaneously with the 
submission each year of the budget for the Food and Drug 
Administration, submit to the Committee on Commerce of the House of 
Representatives and the Committee on Labor and Human Resources of the 
Senate an annual report which shall--
          ``(1) review the performance of the Food and Drug 
        Administration in meeting its mission and the development of 
        Food and Drug Administration policies to implement such 
        mission;
          ``(2) review the performance of the Food and Drug 
        Administration in meeting its own performance standards, 
        including its own outcome measurements, and statutory deadlines 
        for the approval of products or for other purposes contained in 
        this Act;
          ``(3) describe the staffing and resources of the Food and 
        Drug Administration;
          ``(4)(A) list each bilateral and multinational meeting held 
        by the Food and Drug Administration to address methods and 
        approaches to reduce the burden of regulation, to harmonize 
        regulation, and to seek appropriate reciprocal arrangements, 
        (B) describe the goals, activities, and accomplishments of the 
        Food and Drug Administration in such meetings, and (C) list 
        issues that the Food and Drug Administration is considering or 
        has presented for each such meeting; and
          ``(5) summarize and explain each instance in the previous 
        fiscal year in which an application received under section 
        515(c) was not reviewed in a manner to achieve final action on 
        such application within 180 days of its receipt.''.

SEC. 3. DISPUTE RESOLUTION.

  Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after 
section 506 the following:
                          ``dispute resolution
  ``Sec. 506A. If, regarding an obligation under this Act, there is a 
scientific controversy between the Secretary and a person who is a 
sponsor, applicant, or manufacturer, and no specific provision of this 
Act or regulation promulgated under this Act provides a right of review 
of the matter in controversy, the Secretary shall, by regulation, 
establish a procedure under which such sponsor, applicant, or 
manufacturer may request a review of such controversy by an appropriate 
scientific advisory panel under section 515(g)(2)(B). Such review shall 
take place in a timely manner. The Secretary shall promulgate such 
regulations not later than 180 days after the date of the enactment of 
the Medical Device Regulatory Modernization Act of 1997.''.

SEC. 4. INVESTIGATIONAL DEVICE EXEMPTIONS; EXPANDED ACCESS.

  Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at the end 
the following:
  ``(6)(A) Not later than 120 days after the date of the enactment of 
the Medical Device Regulatory Modernization Act of 1997, the Secretary 
shall by regulation establish, with respect to a device for which an 
exemption under this subsection is in effect, the following:
          ``(i) Procedures and conditions under which the Secretary 
        will, without requiring an additional approval of an 
        application for an exemption or the approval of a supplement to 
        such an application, permit--
                  ``(I) developmental changes in the device that do not 
                constitute a significant change in design or in basic 
                principles of operation and that are made in response 
                to information gathered during the course of an 
                investigation; and
                  ``(II) changes or modifications to clinical protocols 
                that do not affect the validity of data or information 
                resulting from the completion of an approved protocol 
                and do not alter the relationship of likely patient 
                risk to benefit relied upon to approve a protocol.
          ``(ii) Procedures and conditions under which the Secretary 
        will, outside of an approved investigational protocol (subject 
        to compliance with regulations for the protection of patients), 
        permit uses of the device in the diagnosis, monitoring, or 
        treatment of diseases or conditions that are life-threatening 
        or could be irreversibly debilitating, when--
                  ``(I) the treating physician determines that the 
                investigational use of the device likely will provide a 
                benefit; that the risk of not using the device exceeds 
                the probable risk of using the device; and that there 
                is no legally marketed device alternative for the 
                satisfactory treatment or diagnosis of such disease or 
                condition;
                  ``(II) the Secretary determines that there is 
                sufficient evidence of safety and effectiveness to 
                support the investigational use of the device in the 
                case described in subclause (I);
                  ``(III) the Secretary determines that the 
                investigational use of the device will not interfere 
                with the initiation, conduct, or completion of clinical 
                investigations to support marketing approval; and
                  ``(IV) the sponsor, or clinical investigator, of the 
                investigational use of the device submits to the 
                Secretary a clinical protocol consistent with the 
                provisions of paragraph (3) and any regulations 
                promulgated under such paragraph describing the 
                investigational use of devices in a single patient or a 
                small group of patients.
  ``(B) Regulations under subparagraph (A)(i) shall provide that a 
change or modification described in such subparagraph is not permitted 
unless, not later than 5 days after making the change or modification, 
a notice of the change or modification is submitted to the Secretary.
  ``(C) Regulations under subparagraph (A)(ii) shall provide that, 
under appropriate conditions described by the Secretary in the 
regulations, the Secretary will authorize the shipment of 
investigational devices (as defined in the regulations) for the 
diagnosis, monitoring, or treatment of a serious disease or condition 
in emergency situations.
  ``(7)(A) In the case of a person intending to investigate the safety 
or effectiveness of a class III device or an implantable device, the 
Secretary shall ensure that the person has an opportunity, prior to 
submitting an application to the Secretary or to an institutional 
review board, to submit to the Secretary, for review, an 
investigational plan (including a clinical protocol). If the applicant 
requests a meeting with the Secretary regarding such review, the 
Secretary shall meet with the applicant not later than 30 days after 
receiving the request for the meeting.
  ``(B) Agreements regarding the parameters of an investigational plan 
(including clinical protocol) that are reached between the Secretary 
and a sponsor or applicant shall be reduced to writing and made part of 
the administrative record by the Secretary. Such agreements shall not 
be changed, except--
          ``(i) with the written agreement of the sponsor or applicant; 
        or
          ``(ii) pursuant to a decision, made in accordance with 
        subparagraph (C) by the director of the office in which the 
        device involved is reviewed, that a substantial scientific 
        issue essential to determining the safety or effectiveness of 
        the device involved has been identified.
  ``(C) A decision under subparagraph (B)(ii) by the director shall be 
in writing, and may be made only after the Secretary has provided to 
the sponsor or applicant an opportunity for a meeting at which the 
director and the sponsor or applicant are present and at which the 
director documents the scientific issue involved.''.

SEC. 5. SPECIAL REVIEW FOR CERTAIN DEVICES.

  Section 515(d) (21 U.S.C. 360e(d)) is amended--
          (1) by redesignating paragraphs (2) and (3) as paragraphs (3) 
        and (4), respectively; and
          (2) by adding at the end the following:
  ``(5) In order to provide for more effective treatment or diagnosis 
of life-threatening or irreversibly debilitating human diseases or 
conditions, the Secretary shall provide review priority for devices--
          ``(A) representing breakthrough technologies,
          ``(B) for which no approved alternatives exist,
          ``(C) which offer significant advantages over existing 
        approved alternatives, or
          ``(D) the availability of which is in the best interest of 
        the patients.''.

SEC. 6. EXPANDING HUMANITARIAN USE OF DEVICES.

  (a) Section 520(m).--Section 520(m) (21 U.S.C. 360j(m)) is amended--
          (1) in paragraph (2), by inserting after and below 
        subparagraph (C) the following:
``The request shall be in the form of an application to the Secretary. 
Within 60 days of the date of the receipt of an application, the 
Secretary shall issue an order approving or denying the application, 
except that if the Secretary convenes a scientific advisory panel, the 
Secretary shall within 120 days of the receipt of an application issue 
such order.'';
          (2) by amending paragraph (5) to read as follows:
  ``(5) The Secretary may suspend or withdraw an exemption from the 
effectiveness requirements of sections 514 and 515 for a humanitarian 
device, after providing notice and an opportunity for an informal 
hearing, if any condition for granting such exemption for such device 
set forth in paragraphs (2) through (4) no longer is met.''; and
          (3) by amending paragraph (6) to read as follows:
  ``(6) The Secretary may require a person granted an exemption under 
paragraph (2) to demonstrate continued compliance with the requirements 
of this subsection if the Secretary believes such demonstration to be 
necessary to protect the public health or if the Secretary has reason 
to believe that the criteria for the exemption are no longer met.''.
  (b) Regulations.--Any provision in a regulation included in title 21 
of the Code of Federal Regulations pertaining to humanitarian devices 
which is inconsistent with the amendments made by subsection (a) shall 
be deemed rescinded on the date of the enactment of this Act. The 
Secretary shall amend regulations pertaining to humanitarian devices to 
conform with the amendments made by subsection (a).

SEC. 7. DEVICE STANDARDS.

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

                   ``Listing of Recognized Standards

  ``(c)(1) The Secretary shall issue notices identifying and adopting 
applicable nationally or internationally recognized standards (or 
portions of such standards) to which a person may self-certify 
compliance for the purpose of demonstrating a reasonable assurance that 
a device is safe or effective or to determine compliance with any 
requirement of this Act. Such notices shall be published in the Federal 
Register, and the Secretary shall provide an opportunity for public 
comment on the standards involved.
  ``(2) The Secretary shall accept a certification that a device 
conforms with each type of standard referenced in subsection (a) and 
identified in such certification to the extent such standard applies, 
except that the Secretary may, at any time, require the person who 
submitted the certification to submit the data and information which 
such person relied upon in making such certification, and may reject 
the certification if the Secretary determines that the data and 
information do not demonstrate compliance with the standards identified 
in the certification. Such person shall maintain the data and 
information for a period of 2 years after the submission of the 
certification, or for the expected design life of the device, whichever 
is later.
  ``(3) The Secretary may remove from the list of standards adopted 
under subsection (a) a standard (or portion of a standard) which the 
Secretary determines is not reliable for the purpose set out in such 
subsection.
  ``(4) In the case of a person who does not self-certify compliance 
pursuant to paragraph (1) regarding a device, the person may elect to 
utilize data other than those required by standards under paragraph (1) 
to demonstrate a reasonable assurance of the safety or effectiveness of 
the device.''.
  (b) Prohibited Acts.--Section 301 (21 U.S.C. 331) is amended by 
adding at the end the following:
  ``(x) The falsification of a certification under section 514(c) or 
the failure or refusal to provide data or information required by the 
Secretary under such section.''.
  (c) Adulterated Devices.--Section 501(e) (21 U.S.C. 351(e)) is 
amended by striking ``subject to a performance standard'' and all that 
follows and inserting the following: ``subject to a performance 
standard established under subsection (b) of section 514, unless such 
device is in all respects in conformity with such standard; or subject 
to a standard listed under subsection (c) of such section (in the case 
of a person who has self-certified to such standard), unless such 
device is in all respects in conformity with such standard.''.
  (d) Conforming Amendments.--
          (1) Definition of class ii device.--Section 513(a)(1)(B) (21 
        U.S.C. 360c(a)(1)(B) is amended by inserting after 
        ``performance standards,'' the following: ``the listing of 
        standards under section 514(c),'' .
          (2) Relationship to performance standards.--Section 514(a) 
        (21 U.S.C. 360d(a)) is amended--
                  (A) in paragraph (1), in the second sentence, by 
                striking ``under this section'' and inserting ``under 
                subsection (b)'';
                  (B) in paragraph (2), in the matter preceding 
                subparagraph (A), by striking ``under this section'' 
                and inserting ``under subsection (b)'';
                  (C) in paragraph (3), by striking ``under this 
                section'' and inserting ``under subsection (b)''; and
                  (D) in paragraph (4), in the matter preceding 
                subparagraph (A), by striking ``this section'' and 
                inserting ``this subsection and subsection (b)''.

SEC. 8. SCOPE OF REVIEW.

  (a) Section 513(a).--Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is 
amended--
          (1) in subparagraph (A) by inserting ``one or more'' before 
        ``clinical investigations''; and
          (2) by adding at the end the following:
  ``(C) In making a determination of a reasonable assurance of the 
effectiveness of a device for which an application under section 515 
has been submitted, the Secretary shall consider whether the extent of 
data that otherwise would be required for approval of the application 
with respect to effectiveness can be reduced through reliance on 
postmarket controls.
  ``(D)(i) Upon the request of any person intending to submit an 
application under section 515, the Secretary shall, not later than 30 
days after receiving such request, 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 proposed conditions of use. Within 30 
days of such meeting, the Secretary shall identify, and confirm in 
writing, the type of valid scientific evidence that will provide a 
reasonable assurance that a device is effective under the proposed 
conditions of use.
  ``(ii) Agreements under section 515 regarding the parameters of valid 
scientific evidence for a device that are reached between the Secretary 
and a sponsor or applicant shall be reduced to writing and made part of 
the administrative record by the Secretary. Such agreements shall not 
be changed, except--
          ``(I) with the written agreement of the sponsor or applicant; 
        or
          ``(II) pursuant to a decision, made in accordance with clause 
        (iii) by the director of the office in which the device 
        involved is reviewed, that a substantial scientific issue 
        essential to determining the safety or effectiveness of the 
        device has been identified.
  ``(iii) A decision under clause (ii) by the director shall be in 
writing, and may be made only after the Secretary has provided to the 
sponsor or applicant an opportunity for a meeting at which the director 
and the sponsor or applicant are present and at which the director 
documents the scientific issue involved.''.
  (b) Section 513(i).--Section 513(i)(1) (21 U.S.C. 360c(i)(1)) is 
amended 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) of this section.
  ``(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 request, the Secretary shall consider the least burdensome means 
of demonstrating substantial equivalence and request information 
accordingly.
  ``(E)(i) Any determination by the Secretary of the intended use of a 
device shall be based upon the proposed labeling submitted in a report 
for the device under section 510(k), unless the director of the 
organizational unit responsible for regulating devices (in this 
subparagraph referred to as the `Director'), after providing an 
opportunity for consultation with the person who submitted such report, 
determines and states in writing (I) that there is a reasonable 
likelihood that the device will be used for an intended use not 
identified in the proposed labeling for the device, and (II) on the 
basis of data or the absence of data, that such use could cause harm.
  ``(ii) Such determination shall--
          ``(I) be provided to the person who submitted the report 
        within 10 days from the date of the notification of the 
        Director's concerns regarding the proposed labeling;
          ``(II) specify limitations on the device's labeling which 
        proscribe the use not included in proposed labeling; and
          ``(III) find the device substantially equivalent when the 
        labeled intended use and the technological characteristics of 
        the device relative to a legally marketed device conform with 
        the requirements of subparagraph (A).
  ``(iii) The responsibilities of the Director under this subparagraph 
may not be delegated.
  ``(iv) This subparagraph has no legal effect after the expiration of 
the five-year period beginning on the date of the enactment of the 
Medical Device Regulatory Modernization Act of 1997.''.
  (c) Section 515(d).--Section 515(d) (21 U.S.C. 360e(d)) is amended--
          (1) in paragraph (1)(A), by adding after and below clause 
        (ii) the following:
``In making the determination whether to approve or deny the 
application, the Secretary shall rely on the conditions of use included 
in the proposed labeling as the basis for determining whether or not 
there is a reasonable assurance of safety and effectiveness, if the 
proposed labeling is neither false nor misleading. In determining 
whether or not such labeling is false or misleading, the Secretary 
shall fairly evaluate all material facts pertinent to the proposed 
labeling.''; and
          (2) by adding after paragraph (5) (as added by section 5(2)) 
        the following:
  ``(6)(A)(i) A supplemental application shall be required for any 
change to a device subject to an approved application under this 
subsection that affects safety or effectiveness, unless such change is 
a modification in a manufacturing procedure or method of manufacturing 
and the holder of the approved application submits a written notice to 
the Secretary that describes in detail the change, summarizes the data 
or information supporting the change, and informs the Secretary that 
the change has been made under the requirements of section 520(f).
  ``(ii) The holder of an approved application who submits a notice 
under clause (i) with respect to a manufacturing change of a device may 
distribute the device 30 days after the date on which the Secretary 
receives the notice, unless the Secretary within such 30-day period 
notifies the holder that the notice is not adequate and describes such 
further information or action that is required for acceptance of such 
change. If the Secretary notifies the holder that a premarket approval 
supplement is required, the Secretary shall review the supplement 
within 135 days after the receipt of the supplement. The time used by 
the Secretary to review the notice of the manufacturing change shall be 
deducted from the 135-day review period if the notice meets appropriate 
content requirements for premarket approval supplements.
  ``(B)(i) Subject to clause (ii), 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 such supplement if--
          ``(I) nonclinical data demonstrate that the design 
        modification creates the intended additional capacity, 
        function, or performance of the device; and
          ``(II) clinical data from the approved application and any 
        supplement to the approved application provide a reasonable 
        assurance of safety and effectiveness for the changed device.
  ``(ii) The Secretary may require, when necessary, additional clinical 
data to evaluate the design modification of the device to provide a 
reasonable assurance of safety and effectiveness.''.

SEC. 9. PREMARKET NOTIFICATION.

  (a) Section 510.--Section 510 (21 U.S.C. 360) is amended--
          (1) in subsection (k)--
                  (A) in the matter preceding paragraph (1), by adding 
                after ``report to the Secretary'' the following: ``or 
                person who is accredited under section 712(a)''; and
                  (B) by adding after and below paragraph (2) the 
                following:
``Such a report is not required for a device intended for human use 
that is exempted from the requirements of this subsection under 
subsection (l) or is classified into class I under section 513. The 
exception established in the preceding sentence does not apply to any 
class I device that is intended to be life supporting or life 
sustaining or is intended for a use which is of substantial importance 
in preventing impairment of human health, or to any class I device that 
presents a potential unreasonable risk of illness or injury. With 
respect to a person who is accredited under section 712(a), such 
accredited person shall review a report under this subsection that is 
received by such person and shall submit, not later than 60 days after 
receiving the report, to the Secretary such person's recommendation for 
action to be taken by the Secretary on the report.''; and
          (2) by adding after subsection (k) the following subsection:
  ``(l) Not later than 30 days after the date of the enactment of the 
Medical Device Regulatory Modernization Act of 1997, the Secretary 
shall 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 listed by the Secretary 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. Beginning on the date that is 1 day 
after the date of the publication of the list, any person may petition 
the Secretary to exempt a type of class II device from the reporting 
requirement of subsection (k). The Secretary shall publish in the 
Federal Register notice of the intent of the Secretary to exempt the 
device, or of the petition, and provide a 30-day period for public 
comment. If the Secretary fails to respond to a petition within 120 
days of receiving it, the petition shall be deemed to be granted.''.
  (b) Initial Classification.--Section 513(f) (21 U.S.C. 360c(f)) is 
amended--
          (1) in the second sentence of paragraph (1) by striking the 
        period at the end and inserting the following: ``unless within 
        30 days of receiving an order classifying the device into class 
        III the person who submits a report under section 510(k) for 
        such device requests review with respect to the classification 
        of the device and a final order of classification from the 
        Secretary. Such person shall submit to the Secretary data and 
        information supporting the classification of the device into 
        class I or II. After the request, a device classified into 
        class III under this paragraph remains in class III, but shall 
        not be deemed to be finally classified until the Secretary has 
        determined the classification of the device based on the 
        classification criteria set forth in subparagraphs (A) through 
        (C) of subsection (a)(1), within 60 days of receiving the 
        request to review and classify a device. Any device found under 
        this paragraph not to be substantially equivalent to a device 
        described in subparagraph (A)(i) and which is classified by the 
        Secretary into class III may not be commercially distributed in 
        commerce before it is approved under section 515.''; and
          (2) by adding at the end the following:
  ``(4) The Secretary may not withhold a determination of the initial 
classification of a device under paragraph (1) because of a failure to 
comply with any provision of this Act unrelated to a substantial 
equivalence decision, including a finding that the facility in which 
the device is manufactured is not in compliance with good manufacturing 
requirements as set forth in regulations of the Secretary under section 
520(f) (other than a finding that the failure to comply with such 
regulations is directly related to the safety or effectiveness of the 
device).''.
  (c) Section  513.--Section 513(i)(1) (21 U.S.C. 360c(i)), as amended 
by section 8(b), is amended--
          (1) in subparagraph (A)(ii)(I), by striking ``clinical data'' 
        and inserting ``appropriate clinical or scientific data'' and 
        by inserting ``or a person accredited under section 712'' after 
        ``Secretary'';
          (2) in subparagraph (A)(ii)(II), by striking ``efficacy'' and 
        inserting ``effectiveness''; and
          (3) by adding at the end of paragraph (1) the following:
  ``(F) For purposes of subparagraph (A), the term `legally marketed 
device' includes any device introduced into interstate commerce for 
commercial distribution before May 28, 1976, and any device determined 
to be substantially equivalent to such device which has not been 
removed from the market by an order of the Secretary or a judicial 
order because it is not safe or not effective.
  ``(G) Not later than 270 days after the date of the enactment of the 
Medical Device Regulatory Modernization Act of 1997, the Secretary 
shall issue guidance specifying the general principles that the 
Secretary will consider in determining when a specific intended use of 
a device is not reasonably included within a general use of such device 
for purposes of a determination of substantial equivalence under 
subsection (f) or section 520(l).''.
  (d) Sunset.--The amendments made by subsections (a)(1)(A) and (c)(1), 
to the extent that they relate to an accredited person under section 
712 of the Federal Food, Drug, and Cosmetic Act, shall be of no force 
or effect upon the expiration of 7 years from the date of the enactment 
of this Act.

SEC. 10. CLASSIFICATION PANELS.

  Section 513(b) (21 U.S.C. 360c(b)) is amended by adding at the end 
the following:
  ``(5) Classification panels covering each type of device shall be 
scheduled to meet at such times as may be appropriate for the Secretary 
to meet applicable statutory deadlines.
  ``(6)(A) Any person whose device is specifically the subject of 
review by a classification panel shall have the same rights as the 
Secretary regarding--
          ``(i) access to data and information submitted to a 
        classification panel (except for data and information that are 
        not available for public disclosure under section 552 of title 
        5, United States Code);
          ``(ii) the submission, for review by a classification panel, 
        of information that is based on the data or information 
        provided in the application submitted under section 515 by the 
        person, which information shall be submitted to the Secretary 
        for prompt transmittal to the classification panel; and
          ``(iii) the participation of the persons at meetings of the 
        panel.
  ``(B) Any meetings of a classification panel shall provide adequate 
time for initial presentations and for response to any differing views 
by persons whose devices are specifically the subject of a 
classification panel review, and shall encourage free and open 
participation by all interested persons.
  ``(7) After receiving from a classification panel the conclusions and 
recommendations of the panel on a matter that the panel has reviewed, 
the Secretary shall review the conclusions and recommendations, shall 
make a final decision on the matter in accordance with section 
515(d)(2), and shall notify the affected persons of the decision in 
writing and, if the decision differs from the conclusions and 
recommendations of the panel, shall include the reasons for the 
difference.
  ``(8) A scientific advisory panel under this subsection shall not be 
subject to the annual chartering and annual report requirements of the 
Federal Advisory Committee Act.''.

SEC. 11. PREMARKET APPROVAL.

  Section 515(d) (21 U.S.C. 360e(d)), as amended by section 5(1), is 
amended by inserting after paragraph (1) the following:
  ``(2) Each application received under subsection (c) shall be 
reviewed in a manner to achieve final action on such application within 
180 days of its receipt. At the request of the applicant, the Secretary 
shall meet with an applicant under such an application within 90 days 
of the date of the application's submission.''.

SEC. 12. ACCREDITATION FOR ACCREDITED PERSONS.

  (a) Amendment.--Subchapter A of chapter VII is amended by adding at 
the end the following:
                          ``accredited persons
  ``Sec. 712. (a) In General.--The Secretary shall, not later than 1 
year after the date of the enactment of the Medical Device Regulatory 
Modernization Act of 1997, accredit persons for the purpose of 
reviewing and initially classifying devices under section 513(f)(1) 
that are subject to a report under section 510(k). An accredited person 
may not be used to perform a review of a class III device, or a class 
II device which is intended to be permanently implantable or life 
sustaining or life supporting.
  ``(b) Accreditation.--
          ``(1) Programs.--The Secretary shall provide for such 
        accreditation through programs administered by the Food and 
        Drug Administration, other government agencies, or by other 
        qualified nongovernment organizations.
          ``(2) Accreditation.--
                  ``(A) General rule.--Not later than 180 days after 
                the date of the enactment of the Medical Device 
                Regulatory Modernization Act of 1997, the Secretary 
                shall establish and publish in the Federal Register 
                requirements to accredit or deny accreditation to 
                persons who request to perform the duties specified in 
                subsection (a). The Secretary shall respond to a 
                request for accreditation within 60 days of the receipt 
                of the request. The accreditation of such person shall 
                specify the particular activities under subsection (a) 
                for which such person is accredited.
                  ``(B) Withdrawal of accreditation.--The Secretary may 
                withdraw accreditation of any person accredited under 
                this paragraph, after providing notice and an 
                opportunity for an informal hearing, when such person 
                acts or fails to act in a manner that is inconsistent 
                with the purposes of this section or poses a threat to 
                public health.
                  ``(C) Performance auditing.--To ensure that persons 
                accredited under this section will continue to meet the 
                standards of accreditation, the Secretary shall--
                          ``(i) make onsite visits on a periodic basis 
                        to each accredited person to audit the 
                        performance of such person; and
                          ``(ii) take such additional measures as the 
                        Secretary determines to be appropriate.
                  ``(D) Annual report.--The Secretary shall include in 
                the annual report required under section 903(e)(2) the 
                names of all accredited persons and the particular 
                activities under subsection (a) for which each such 
                person is accredited and the name of each accredited 
                person whose accreditation has been withdrawn during 
                the year.
          ``(3) Qualifications.--An accredited person shall, at a 
        minimum, meet the following requirements:
                  ``(A) Such person shall be an independent 
                organization which is not owned or controlled by a 
                manufacturer, supplier, or vendor of devices and which 
                has no organizational, material, or financial 
                affiliation with such a manufacturer, supplier, or 
                vendor.
                  ``(B) Such person shall be a legally constituted 
                entity permitted to conduct the activities for which it 
                seeks accreditation.
                  ``(C) Such person shall not engage in the design, 
                manufacture, promotion, or sale of devices.
                  ``(D) Such person shall be operated in accordance 
                with generally accepted professional and ethical 
                business practices and shall agree in writing that as a 
                minimum it will--
                          ``(i) certify that reported information 
                        accurately reflects data reviewed;
                          ``(ii) limit work to that for which 
                        competence and capacity are available;
                          ``(iii) treat information received, records, 
                        reports, and recommendations as proprietary 
                        information;
                          ``(iv) promptly respond and attempt to 
                        resolve complaints regarding its activities for 
                        which it is accredited; and
                          ``(v) protect against the use, in carrying 
                        out subsection (a) with respect to a device, of 
                        any officer or employee of the person who has a 
                        financial conflict of interest regarding the 
                        device, and annually make available to the 
                        public disclosures of the extent to which the 
                        person, and the officers and employees of the 
                        person, have maintained compliance with 
                        requirements under this clause relating to 
                        financial conflicts of interest.
          ``(4) Selection of accredited persons.--The Secretary shall 
        provide each person who chooses to use an accredited person to 
        receive a section 510(k) report a panel of at least 2 or more 
        accredited persons from which the regulated person may select 1 
        for a specific regulatory function.''.
  (b) Conforming Amendment.--Section 301 (21 U.S.C. 321), as amended by 
section 7(b), is amended by adding at the end the following:
  ``(y) In the case of a drug, device, or food--
          ``(1) the submission of a report or recommendation by a 
        person accredited under section 712 that is false or misleading 
        in any material respect;
          ``(2) the disclosure by a person accredited under section 712 
        of confidential commercial information or any trade secret 
        without the express written consent of the person who submitted 
        such information or secret to such person; or
          ``(3) the receipt by a person accredited under section 712 of 
        a bribe in any form or the doing of any corrupt act by such 
        person associated with a responsibility delegated to such 
        person under this Act.''.
  (c) Sunset.--The amendments made by subsections (a) and (b) to the 
extent they relate to an accredited person under section 712 of the 
Federal Food, Drug, and Cosmetic Act shall be of no force or effect 
upon the expiration of 7 years from the date of the enactment of this 
Act.
  (d) Report.--Not later than 5 years after the date of the enactment 
of this Act, the Comptroller General of the United States shall report 
to the Committee on Commerce of the House of Representatives and the 
Committee on Labor and Human Resources of the Senate on the use of 
accredited persons under section 712 of the Federal Food, Drug, and 
Cosmetic Act, the extent to which such use was helpful in the 
implementation of such Act, and the extent to which such use promoted 
actions which were contrary to the purposes of such Act.

SEC. 13. PREAMENDMENT DEVICES.

  Section 515(i) (21 U.S.C. 360e(i)) is amended to read as follows:

                               ``Revision

  ``(i) Not later than 180 days after the date of the enactment of the 
Medical Device Regulatory Modernization Act of 1997, the Secretary 
shall publish in the Federal Register a list of the types of devices 
classified into class III under section 513(d), which are not subject 
to a regulation under subsection (b), and for which the Secretary has 
determined after classification of such devices that premarket approval 
is unnecessary to protect the public health. Each such type of device 
listed in the Federal Register publication shall be reclassified into 
class II or class I, as appropriate.''.

SEC. 14. DEVICE TRACKING.

  Subsection (e) of section 519 (21 U.S.C. 360i) is amended to read as 
follows:

                           ``Device Tracking

  ``(e) The Secretary may by order require a manufacturer to adopt a 
method of tracking a class II or class III device--
          ``(1) the failure of which would be reasonably likely to have 
        serious adverse health consequences; or
          ``(2) which is--
                  ``(A) intended to be an implantable device, or
                  ``(B) a life sustaining or life supporting device 
                used outside a device user facility.''.

SEC. 15. POSTMARKET SURVEILLANCE.

  Section 522 (21 U.S.C. 360l) is amended to read as follows:
                       ``postmarket surveillance
  ``Sec. 522. (a) In General.--The Secretary may by order require a 
manufacturer to conduct postmarket surveillance for any device of the 
manufacturer which is a class II or class III device the failure of 
which would be reasonably likely to have serious adverse health 
consequences or which is intended to be--
          ``(1) an implantable device, or
          ``(2) a life-sustaining or life-supporting device used 
        outside a device user facility.
  ``(b) Surveillance Approval.--Each manufacturer required to conduct a 
surveillance of a device shall, within 30 days of receiving an order 
from the Secretary prescribing that the manufacturer is required under 
this section to conduct such surveillance, submit, for the approval of 
the Secretary, a plan for the required surveillance. The Secretary, 
within 60 days of the receipt of such plan, shall determine if the 
person designated to conduct the surveillance has appropriate 
qualifications and experience to undertake such surveillance and if 
such plan will result in information necessary to determine the 
occurrence of unforeseen events. The Secretary, in consultation with 
the manufacturer, may by order require a prospective surveillance 
period of up to 36 months. Any determination by the Secretary that a 
longer period is necessary shall be made by mutual agreement between 
the Secretary and the manufacturer or, if no agreement can be reached, 
after the completion of a dispute resolution process as described in 
section 506A.''.

SEC. 16. HARMONIZATION.

  (a) Section 520(f).--Section 520(f)(1)(B) (21 U.S.C. 360j(f)(1)(B)) 
is amended by striking ``and'' at the end of clause (i), by striking 
the period at the end of clause (ii) and inserting ``; and'' and by 
adding after clause (ii) the following:
          ``(iii) ensure that such regulation conforms, to the extent 
        practicable, with internationally recognized standards defining 
        quality systems, or parts thereof, for medical devices.''.
  (b) Section 803.--Section 803 (21 U.S.C. 383) is amended by adding at 
the end the following:
  ``(c)(1) The Secretary shall participate in meetings with 
representatives of other countries to discuss methods and approaches to 
reduce the burden of regulation and harmonize regulatory requirements 
if the Secretary determines that such harmonization continues consumer 
protections consistent with the purposes of this Act. The Secretary 
shall, not later than 180 days after the date of enactment of the 
Medical Device Regulatory Modernization Act of 1997, make public a plan 
that establishes a framework for achieving mutual recognition of good 
manufacturing practices inspections.
  ``(2) The Secretary shall report to the Committee on Commerce of the 
House of Representatives and the Committee on Labor and Human Resources 
of the Senate at least 60 days before executing any bilateral or 
multilateral agreement under paragraph (1).''.

SEC. 17. REPORTS.

  (a) Reports.--Section 519 (21 U.S.C. 360i) is amended--
          (1) in subsection (a)--
                  (A) in the matter preceding paragraph (1), by 
                striking ``manufacturer, importer, or distributor'' and 
                inserting ``manufacturer or importer''; and
                  (B) by striking paragraph (9) and inserting the 
                following:
          ``(9) shall require distributors to keep records and make 
        such records available to the Secretary upon request.'';
          (2) by striking subsection (d); and
          (3) in subsection (f), by striking ``, importer, or 
        distributor'' each place it appears and inserting ``or 
        importer''.
  (b) Registration.--Section 510(g) (21 U.S.C. 360(g)) is amended--
          (1) by redesignating paragraph (4) as paragraph (5);
          (2) by inserting after paragraph (3) the following:
          ``(4) any distributor who acts as a wholesale distributor of 
        devices, and who does not manufacture, repackage, process, or 
        relabel a device; or''; and
          (3) by adding at the end the following flush sentence:
``In this subsection, the term `wholesale distributor' means any person 
who distributes a device from the original place of manufacture to the 
person who makes the final delivery or sale of the device to the 
ultimate consumer or user.''.
  (c) Device User Facilities.--
          (1) In general.--Section 519(b) (21 U.S.C. 360i(b)) is 
        amended--
                  (A) in paragraph (1)(C)--
                          (i) in the first sentence, by striking ``a 
                        semi-annual basis'' and inserting ``an annual 
                        basis'';
                          (ii) in the second sentence, by striking 
                        ``and July 1''; and
                          (iii) by striking the matter after and below 
                        clause (iv); and
                  (B) in paragraph (2)--
                          (i) in subparagraph (A), by inserting ``or'' 
                        after the comma at the end;
                          (ii) in subparagraph (B), by striking ``, 
                        or'' at the end and inserting a period; and
                          (iii) by striking subparagraph (C).
          (2) Sentinel system.--Section 519(b) (21 U.S.C. 360i(b)) is 
        amended--
                  (A) by redesignating paragraph (5) as paragraph (6); 
                and
                  (B) by inserting after paragraph (4) the following 
                paragraph:
  ``(5) With respect to device user facilities that are hospitals or 
nursing homes:
          ``(A) The Secretary shall by regulation plan and implement a 
        program under which the Secretary limits user reporting under 
        paragraphs (1) through (4) to a subset of hospitals and nursing 
        homes that constitutes a representative profile of user reports 
        for device deaths and serious illnesses or serious injuries.
          ``(B) During the period of planning the program under 
        subparagraph (A), paragraphs (1) through (4) continue to apply 
        to such device user facilities.
          ``(C) During the period in which the Secretary is providing 
        for a transition to the full implementation of the program, 
        paragraphs (1) through (4) apply to such facilities except to 
        the extent that the Secretary determines otherwise.
          ``(D) On and after the date on which the program is fully 
        implemented, paragraphs (1) through (4) do not apply to such a 
        facility unless the facility is included in the subset referred 
        to in subparagraph (A).
          ``(E) Not later than one year after the date of the enactment 
        of the Medical Device Regulatory Modernization Act of 1997, the 
        Secretary shall submit to the Committee on Commerce of the 
        House of Representatives, and to the Committee on Labor and 
        Human Resources of the Senate, a report describing the plan 
        developed by the Secretary under subparagraph (A) and the 
        progress that has been made toward the implementation of the 
        plan.''.

SEC. 18. INFORMATION SYSTEM.

  Chapter IX is amended by adding at the end the following section:

``SEC. 906. INFORMATION SYSTEM.

  ``The Secretary shall, with respect to devices, establish and 
maintain an information system to track the status and progress of each 
application or submission submitted to the Secretary requesting agency 
action. The system shall permit access by the applicant under 
conditions specified by the Secretary.''.

SEC. 19. PRACTICE OF MEDICINE.

  Chapter IX, as amended by section 18, is amended by adding at the end 
the following:

``SEC. 907. PRACTICE OF MEDICINE.

  ``Nothing in this Act shall be construed to limit or interfere with 
the authority of a health care practitioner to prescribe or administer 
any legally marketed device to a patient for any condition or disease 
within a legitimate health care practitioner-patient relationship. This 
section shall not limit any existing authority of the Secretary to 
establish and enforce restrictions on the sale or distribution, or in 
the labeling, of a device that are part of a determination of 
substantial equivalence, established as a condition of approval, or 
promulgated through regulations. Further, this section shall not change 
any existing prohibition on the promotion of unapproved uses of legally 
marketed devices.''.

SEC. 20. CLARIFICATION OF DEFINITION.

  Section 201(h) (21 U.S.C. 321) is amended by adding at the end the 
following: ``A computer software product shall not be considered a 
device under this paragraph solely on the basis that the primary use of 
such product is related to the provision of health care.''.

SEC. 21. LABELING AND ADVERTISING REGARDING COMPLIANCE WITH STATUTORY 
                    REQUIREMENTS.

  Section 301 (21 U.S.C. 331) is amended by striking paragraph (l).

SEC. 22. NONINVASIVE BLOOD GLUCOSE METER.

  (a) Findings.--The Congress finds that--
          (1) diabetes and its complications are a leading cause of 
        death by disease in America;
          (2) diabetes affects approximately 16,000,000 Americans and 
        another 650,000 will be diagnosed in 1997;
          (3) the total health care-related costs of diabetes total 
        nearly $100,000,000,000 per year;
          (4) diabetes is a disease that is managed and controlled on a 
        daily basis by the patient;
          (5) the failure to properly control and manage diabetes 
        results in costly and often fatal complications including but 
        not limited to blindness, coronary artery disease, and kidney 
        failure;
          (6) blood testing devices are a critical tool for the control 
        and management of diabetes, and existing blood testing devices 
        require repeated piercing of the skin;
          (7) the pain associated with existing blood testing devices 
        creates a disincentive for people with diabetes to test blood 
        glucose levels, particularly children;
          (8) a safe and effective noninvasive blood glucose meter 
        would likely improve control and management of diabetes by 
        increasing the number of tests conducted by people with 
        diabetes, particularly children; and
          (9) the Food and Drug Administration is responsible for 
        reviewing all applications for new medical devices in the 
        United States.
  (b) Sense of Congress.--It is the sense of the Congress that the 
availability of a safe, effective, noninvasive blood glucose meter 
would greatly enhance the health and well-being of all people with 
diabetes across America and the world.

SEC. 23. RULE OF CONSTRUCTION.

  Nothing in this Act or the amendments made by this Act shall be 
construed to affect the question of whether the Secretary of Health and 
Human Services has any authority to regulate any tobacco product, 
tobacco ingredient, or tobacco additive. Such authority, if any, shall 
be exercised under the Federal Food, Drug, and Cosmetic Act as in 
effect on the day before the date of the enactment of this Act.

                          Purpose and Summary

    The purpose of H.R. 1710, the Medical Device Regulatory 
Modernization Act of 1997, is to enact common-sense 
improvements in the current regulatory system that will enable 
the U.S. Food and Drug Administration (FDA) to keep pace with 
medical innovation and enhance patient access to lifesaving, 
life-sustaining, and life-improving medical devices.

                  Background and Need for Legislation

    H.R. 1710, the Medical Device Regulatory Modernization Act 
of 1997, is a compilation of reforms pertaining to existing 
statutory and regulatory requirements concerning medical 
devices. These reforms focus on a number of problems which are 
summarized below.
    The U.S. medical device industry is diverse, consisting of 
thousands of product lines used by more than 50 medical 
specialties in numerous procedures and applications. Most 
product lines generate relatively modest revenues; in fact, 
only an estimated 7 percent of all product line groups have 
annual revenue potential of more than $150 million. As a 
result, the majority of device companies are small (80 percent 
of device firms have fewer than 50 employees; 98 percent have 
fewer than 500) and focus on a single clinical area.
    During this century, major strides in medical technology 
have revolutionized the practice of medicine. In light of 
achievements in such fields as fiber optics, imaging, 
biomaterials, electronics, and biotechnology, today's medical 
technology is faster, more efficient, and more productive than 
ever. These achievements have provided benefits to individual 
patients and to society at large--including better health, more 
cost effective medical treatments, and the return of patients 
to productive lives more quickly.
    However, in many areas, the current regulatory system is 
not keeping pace with medical innovation. For FDA approval, a 
medical device company must submit one of two applications: a 
510(k), or a premarket approval (PMA). A 510(k) is submitted 
for devices that are ``substantially equivalent to'' a device 
placed on the market prior to 1976. A PMA application, which 
must often be supported by extensive clinical data, is required 
when a device is unlike an already marketed device or 
represents a breakthrough medical technology. In a number of 
cases, for both 510(k) and PMA products, increased requirements 
that are burdensome, expensive, and time-consuming have delayed 
patients' access to promising new devices.
    A total of 5,297 510(k) applications were filed with the 
FDA in FY 1996, down significantly from 6,056 in FY 1995 and 
7,022 in FY 1989. In FY 1996, it took the FDA an average of 110 
days to carry out a 510(k) review, not including the time when 
a review was put on hold for manufacturer input of additional 
information. However, the total average review time, including 
such holds (FDA time), was 145 days. The FDA has made recent 
progress in improving review times. For FY 1997, the average 
510(k) review time was 130 days total time (97 days ``FDA 
time''). 5,049 510(k) applications were submitted in FY 1997. 
In addition, the review backlog has been eliminated. However, 
510(k) total review times remain longer than the 90 days called 
for under the Federal Food, Drug, and Cosmetic Act (FFDCA).

                                           510(k) AVERAGE REVIEW TIMES                                          
                                                    [In days]                                                   
----------------------------------------------------------------------------------------------------------------
                                                                                   Fiscal years--               
                                                                 -----------------------------------------------
                                                                   1991    1992    1993    1994    1995    1996 
----------------------------------------------------------------------------------------------------------------
Statutory Review Time...........................................      90      90      90      90      90      90
FDA Time........................................................      81     102     162     184     137     110
Total Time......................................................     102     126     195     216     178     145
Applications Submitted..........................................   5,770   6,509   6,288   6,434   6,056   5,297
----------------------------------------------------------------------------------------------------------------

    With regard to breakthrough devices, 44 PMA applications 
were submitted to the FDA in FY 1996, up from 39 in 1995, but 
down significantly from 84 in 1989. Between 1990 and 1996, 
review times for PMAs of breakthrough devices nearly doubled. 
In FY 1996, it took the FDA an average total time (i.e., actual 
time elapsed from application to approval) of 786 days to 
approve these advanced devices, or more than four times longer 
than the 180 days allowed under the FFDCA. Recent progress has 
been made. In FY 1997, the FDA approved 48 PMAs,taking an 
average total review time of 498 days (375 days ``FDA time''), a 
decline of nearly 37 percent. However, this still is more than double 
the statutory 180-day deadline.

                                            PMA Average Review Times                                            
                                                    [In days]                                                   
----------------------------------------------------------------------------------------------------------------
                                                                                  Fiscal years--                
                                                                 -----------------------------------------------
                                                                   1991    1992    1993    1994    1995    1996 
----------------------------------------------------------------------------------------------------------------
Statutory Review Time...........................................     180     180     180     180     180     180
FDA Time........................................................     335     236     547     649     606     572
Total Time......................................................     633     310     799     823     773     786
Applications Submitted..........................................      75      65      40      43      39      44
----------------------------------------------------------------------------------------------------------------

    The net result of these delays is that American patients do 
not have access to technologies that are often available to 
patients in other countries. This is occurring as companies are 
able to market their products in foreign countries, such as in 
the European Union, before being able to gain FDA approval to 
market them in the United States.

                                Hearings

    In preparation for action on modernization of the Food and 
Drug Administration, the Committee held 17 hearings over the 
last 30 months, including an April 30, 1997, hearing entitled, 
``Medical Devices: Technological Innovation and Patient/
Provider Perspectives.'' The Subcommittee on Health and 
Environment received testimony from the following witnesses: 
Dr. Michael A. Friedman, Lead Deputy Commissioner, Food and 
Drug Administration; Dr. John F. Hansbrough, Director of the 
Regional Burn Center, University of California, San Diego 
Medical Center; Dr. Robert A. Schmidt, Section Chief of 
Mammography, University of Chicago Hospitals; Dr. Joseph M. 
Smith, Assistant Professor of Medicine, Washington University 
School of Medicine; Dr. C. Warren Olanow, Professor and 
Chairman, Department of Neurology, Mount Sinai School of 
Medicine; and Ms. Joy Vaas, Washington, D.C.

                        Committee Consideration

    On September 17, 1997, the Subcommittee on Health and 
Environment met in an open markup session and approved H.R. 
1710 for Full Committee consideration, amended, by a voice 
vote. On September 26, 1997, the Full Committee met in an open 
markup session and ordered H.R. 1710 reported to the House, 
amended, by a voice vote, a quorum being present.

                             Rollcall Votes

    Clause 2(l)(2)(B) of rule XI of the Rules of the House 
requires the Committee to list the recorded votes on the motion 
to report legislation and amendments thereto. There were no 
recorded votes taken in connection with ordering H.R. 1710 
reported or in adopting the amendments. The following are the 
voice votes that were taken in Committee:

                    Voice Votes--September 26, 1997

Bill: H.R. 1710, Medical Device Regulatory Modernization Act of 1997

    Amendment: Amendment in the Nature of a Substitute by Mr. 
Barton.
    Disposition: Agreed to, amended, by a voice vote.
    Amendment: Amendment to the Barton Amendment in the Nature 
of a Substitute by Mr. Waxman re: limiting the role of 
manufacturers in determining the length of postmarket 
surveillance.
    Disposition: Withdrawn, by unanimous consent.
    Amendment: Amendment to the Barton Amendment in the Nature 
of a Substitute by Mr. Barton re: labeling and advertising 
regarding compliance with statutory requirements.
    Disposition: Agreed to, by a voice vote.
    Amendment: Amendment to the Barton Amendment in the Nature 
of a Substitute by Ms. Eshoo re: establishing safeguards in the 
scope of 510(k) application review.
    Disposition: Agreed to, by a voice vote.
    Amendment: Amendment to the Barton Amendment in the Nature 
of a Substitute by Ms. Furse re: add a sense of Congress with 
respect to a noninvasive blood glucose meter.
    Disposition: Agreed to, by a voice vote.
    Amendment: Amendment to the Barton Amendment in the Nature 
of a Substitute by Mr. Klug re: maintaining the classification 
of Class I devices.
    Disposition: Withdrawn, by unanimous consent.
    Amendment: Amendment to the Barton Amendment in the Nature 
of a Substitute by Mr. Markey re: striking the provision on 
device tracking and postmarket surveillance.
    Disposition: Withdrawn, by unanimous consent.
    Amendment: Amendment to the Barton Amendment in the Nature 
of a Substitute by Mr. Waxman re: defining the role of the FDA 
in regulating the practice of medicine.
    Disposition: Withdrawn, by unanimous consent.
    Amendment: Amendment to the Barton Amendment in the Nature 
of a Substitute by Mr. Waxman re: limiting the devices eligible 
for accredited party review.
    Disposition: Withdrawn, by unanimous consent.
    Motion: Motion by Mr. Bliley to order H.R. 1710 reported to 
the House, amended.
    Disposition: Agreed to, by a voice vote, a quorum being 
present.

                      Committee Oversight Findings

    Pursuant to clause 2(l)(3)(A) of rule XI of the Rules of 
the House of Representatives, the Committee has held oversight 
hearings on issues addressed in this legislation.

              Committee on Government Reform and Oversight

    Pursuant to clause 2(l)(3)(D) of rule XI of the Rules of 
the House of Representatives, no oversight findings have been 
submitted to the Committee by the Committee on Government 
Reform and Oversight.

               New Budget Authority and Tax Expenditures

    In compliance with clause 2(l)(3)(B) of rule XI of the 
Rules of the House of Representatives, the Committee finds that 
H.R. 1710, would result in no new or increased budget authority 
or tax expenditures or revenues.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 403 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 2(l)(3)(C) of rule XI of the Rules of 
the House of Representatives, the following is the cost 
estimate provided by the Congressional Budget Office pursuant 
to section 403 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                   Washington, DC, October 1, 1997.
Hon. Tom Bliley,
Chairman, Committee on Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 1710, the Medical 
Device Regulatory Modernization Act of 1997.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Anne Hunt.
            Sincerely,
                                         June E. O'Neill, Director.
    Enclosure.

H.R. 1710--Medical Device Regulatory Modernization Act of 1997

    Summary: H.R. 1710 would amend the Food, Drug and Cosmetic 
Act (FD&CA) and the Public Health Service Act to reform the 
Food and Drug Administration's (FDA's) regulatory and approval 
processes for devices. The bill would also require the FDA to 
meet statutory deadlines for approving some device 
applications. Finally, the FDA would be directed to accredit 
independent entities to review certain device applications. CBO 
estimates that enacting H.R. 1710 would result in net 
additional discretionary spending of $13 million in 1998 and 
$70 million over the 1998-2002 period, assuming appropriation 
of the authorized amounts.
    H.R. 1710 contains no intergovernmental mandates as defined 
in the Unfunded Mandates Reform Act and would impost no costs 
on state, local, or tribal governments. The bill would reduce 
the costs of existing private-sector mandates.
    Estimated cost of the Federal Government: The estimated 
budgetary impact of H.R. 1710 is shown in the following table. 
For the purposes of this estimate, CBO assumes that all amounts 
authorized in the bill would be appropriated by the start of 
each fiscal year and that outlays would follow the historical 
spending patterns for the FDA. The costs of this legislation 
fall within budget function 550 (Health).

----------------------------------------------------------------------------------------------------------------
                                                             By fiscal years, in millions of dollars--          
                                                  --------------------------------------------------------------
                                                     1996     1997     1998     1999     2000     2001     2002 
----------------------------------------------------------------------------------------------------------------
                                        SPENDING SUBJECT TO APPROPRIATION                                       
                                                                                                                
Spending by FDA Under Current Law:                                                                              
    Estimated Authorization Level................      877      887      919      949      982    1,016    1,050
    Estimated Outlays............................      866      895      914      937      971    1,005    1,038
Proposed Changes:                                                                                               
    Estimated Authorization Level................        0        0       13       14       13       14       16
    Estimated Outlays............................        0        0        9       13       13       14       15
Spending by FDA Under H.R. 1710:                                                                                
    Estimated Authorization Level \1\............      877      887      932      963      995    1,030    1,066
    Estimated Outlays............................      866      895      923      950      984    1,019    1,053
----------------------------------------------------------------------------------------------------------------
\1\ The 1996 and 1997 levels are the amounts appropriated for those years.                                      

    Basis of estimate: H.R. 1710 would amend the FDA's approval 
and regulatory processes with the intent of accelerating 
product approvals and reducing regulatory requirements. Under 
this bill, manufacturers of class III devices could petition 
for the reclassification of their products. The bill would 
direct the FDA to comply with statutory deadlines for reviewing 
certain device applications and to accredit third-party 
reviewers. Finally, the proposal would require the FDA to 
establish an information system to track device applications 
and submissions. Other provisions of the bill would have no 
significant budgetary impact.
    Reclassification of Class III Devices. H.R. 1710 would 
change the FDA's current practice of automatically designating 
as class III products new devices that are not substantially 
equivalent to a legally marketed predicate device. Sponsors of 
devices designated as class III could submit to the FDA 
information supporting a class I or II determination, and could 
make a recommendation about the classification of their 
product. The FDA would have 60 days to make a final 
determination on the sponsor's recommendation. This provision 
would reduce the number of premarket applications reviewed by 
the FDA, saving $2 million in 1998 and $12 million over five 
years.
    Enforced Deadlines for FDA Action on Submissions. Under 
this provision, the FDA would be directed to complete action on 
applications for premarket approval (PMA) of class III devices 
within 180 days. This provision would therefore bring the FDA 
into compliance with the statutory deadline for reviewing PMA 
applications.
    Assuming that the volume and quality standards for reviews 
were to remain constant, the FDA would require additional staff 
and resources to reduce its current device review times 
significantly. Because H.R. 1710 would somewhat relax current 
FDA regulations, the number of product applications could 
increase, placing further demands on the agency's resources. 
CBO estimates that the additional personnel and resources 
necessary to meet the proposed deadlines would exceed any 
savings realized through regulatory relief offered by H.R. 
1710. This provision would cost the federal government an 
estimated $11 million in 1998 and $66 million over five years.
    Third-Party Review of Applications. This provision would 
require the FDA to accredit independent entities for reviewing 
and making initial classification recommendations on section 
510(k) device submissions. Devices that are life-sustaining or 
life-supporting, intended for permanent implantation, or 
designated as class III devices would be exempted from this 
provision. The FDA could evaluate the performance of accredited 
reviewers and rescind their accreditation status when 
necessary. CBO estimates that this proposal would save 
approximately $1 million over five years.
    Application Tracking System. H.R. 1710 would direct the FDA 
to establish an information system to track device applications 
and submissions. Based on information from the FDA, CBO 
estimates that the cost of developing and maintaining this 
system would be $4 million in 1998, and $17 million over five 
years.
    Estimated impact on State, local, and tribal governments: 
H.R. 1710 contains no intergovernmental mandates as defined in 
the Unfunded Mandates Reform Act and would impose no costs on 
state, local, or tribal governments.
    Estimated impact on the private sector: In general, H.R. 
1710 reduces the costs of existing private-sector mandates. In 
at least one instance (section 8, Scope of Review) it would 
replace an existing private-sector mandate with new, less 
burdensome requirements. CBO is uncertain whether other 
sections would add to the cost of complying with regulations 
governing the use of unapproved devices for humanitarian 
purposes. In total, however, CBO concludes that the direct cost 
of all private-sector mandates in this bill would be minimal 
and the total effect could be a net reduction in costs imposed 
on the private sector.
    Estimate prepared by: Federal Cost: Anne Hunt. Impact on 
State, Local, and Tribal Governments: Leo Lex. Impact on the 
Private Sector: Anna Cook.
    Estimate approved by: Robert A. Sunshine, Deputy Assistant 
Director for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation. The bill provides that a device classification 
panel shall not be subject to annual chartering and annual 
reporting requirements under the Federal Advisory Committee 
Act.

                   Constitutional Authority Statement

    Pursuant to clause 2(l)(4) of rule XI of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for this legislation is provided in 
Article I, section 8, clause 3, which grants Congress the power 
to regulate commerce with foreign nations, among the several 
States, and with the Indian tribes.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation

Section 1. Short title; references; table of contents

    The short title for this Act is the ``Medical Device 
Regulatory Modernization Act of 1997.'' All references are to 
sections or provisions of the Federal Food, Drug, and Cosmetic 
Act (FFDCA) (21 U.S.C. 321 et seq.), unless otherwise 
specified.

Sec. 2. FDA mission and annual report

    This section establishes a mission statement under section 
903 for the Food and Drug Administration (FDA). The FDA's 
mission is to promote public health by promptly and efficiently 
reviewing and taking action on regulated products and by 
ensuring that (a) foods are safe, wholesome, sanitary and 
properly labeled; (b) human and veterinary drugs are safe and 
effective; (c) there is a reasonable assurance of safety and 
effectiveness of devices intended for human use; (d) cosmetics 
are safe and properly labeled; and (e) public health and safety 
are protected from electronic product radiation.
    The FDA is required to work with other countries to reduce 
regulatory burdens, harmonize regulatory requirements, and 
achieve appropriate reciprocal arrangements.
    Under section 903, the Secretary of Health and Human 
Services (the Secretary) must submit to the House Committee on 
Commerce and the Senate Committee on Labor and Human Resources 
an annual report containing the following: a review of the 
FDA's performance in meeting its mission and in meeting its own 
performance standards and statutory deadlines for the approval 
of products or other activities under the FFDCA; a description 
of staffing and resources of the FDA; and a list of each 
bilateral and multinational meeting the FDA held to address 
issues pertinent to reducing regulatory burdens, harmonizing 
regulation, and seeking appropriate reciprocal arrangements. 
The annual report must also contain a summary explaining each 
instance in the previous fiscal year in which final action on a 
premarket approval application, filed under section 515(c) of 
the FFDCA, was not achieved within 180 days.
    In addition, the Committee requests that the Secretary, in 
keeping with this legislation's focus on improved FDA 
performance, consider the creation of the position of Chief 
Operating Office at the agency. Such a role could facilitate 
the administration of the agency's operations, with possible 
responsibilities including the establishment of standards of 
performance, determination of performance reviews and employee 
compensation, and oversight of audits of the performance of 
reviewers at the FDA.

Sec. 3. Dispute resolution

    Section 3 amends Chapter V by adding a new section 506A to 
require the Secretary to publish regulations relating to 
procedures for resolving a scientific controversy between the 
Secretary and a regulated person for cases where the FFDCA does 
not provide a right of review. The regulations must include 
procedures under which the regulated person may request a 
review of the controversy by an FDA scientific advisory panel. 
The Secretary must promulgate the regulations within 180 days 
of enactment.

Sec. 4. Investigational device exemptions; expanded access

    This section amends Section 520(g) to provide that within 
120 days of enactment, the Secretary must publish regulations 
relating to investigational device exemptions (IDEs), which 
establish procedures under which the Secretary will, without 
requiring an additional approval of an application, permit (1) 
developmental changes in the device that do not constitute a 
significant change in design or in basic principles of 
operation and that are made in response to information gathered 
during the course of an investigation, and (2) changes or 
modifications to clinical protocols that do not affect the 
validity of data and do not alter the relationship of likely 
patient risk to benefit that was relied upon to approve a 
protocol.
    The Secretary must also establish, by regulation, 
procedures and conditions under which the Secretary will permit 
uses of an investigational device for a single patient or a 
small group of patients where (1) a treating physician 
determines that the investigational use of the device likely 
will provide a benefit, that the risk of not using the device 
exceeds the probable risk of using the device, and that there 
is no legally marketed satisfactory alternative; (2) the 
Secretary determines that there is sufficient evidence of 
safety and effectiveness and that the investigational use of 
the device will not interfere with clinical investigations to 
support marketing approval; and (3) the sponsor or investigator 
has filed an appropriate clinical protocol. The Committee notes 
that the FDA's recently issued treatment-IDE regulations 
provide another means for expanded access.
    The regulations under subparagraph (A)(ii) must provide 
that changes to the IDE as established under new subparagraph 
(A)(i) are permitted only if the Secretary is notified within 
five days of the modification. The regulations must also 
provide that, under appropriate conditions, the Secretary will 
authorize the shipment of investigational devices in a medical 
emergency. For class III or implantable devices, the Secretary 
must ensure that the device sponsor has an opportunity to 
preview an investigational plan or clinical protocol with the 
Secretary before submitting it to an institutional review board 
or the Secretary for review. If a preview consultation is 
requested, the Secretary must meet with the applicant within 30 
days of receiving a request. Any agreements that the Secretary 
and device sponsor reach during the consultation must be 
reduced to writing and made part of the Secretary's 
administrative record. Such agreements may be changed with the 
written agreement of the sponsor, or pursuant to a written 
decision by the reviewing office director, after providing the 
sponsor with an opportunity for a meeting, that a substantial 
scientific issue essential to determining the safety or 
effectiveness of the device has been identified.
    In requiring that the Secretary meet with a sponsor to 
discuss a planned protocol, the Committee recognizes that 
valuable resources will be expended by technical experts at the 
FDA and representing the sponsor. The Committee expects, 
therefore, that any such meeting be a productive one. To ensure 
this, the sponsor must have provided the FDA with sufficient 
background and other information so the appropriate FDA 
personnel can be available and prepared for the meeting. The 
FDA is not expected to agree to any meeting requests where 
sponsors have not provided the necessary information.

Sec. 5. Special review for certain devices

    Section 5 amends Section 515 to require the Secretary to 
establish a priority system for reviewing medical devices (A) 
representing breakthrough technologies, (B) for which no 
approved alternatives exist, (C) which offer significant 
advantages over existing approved therapies, or (D) the 
availability of which is in the best interest of patients.

Sec. 6. Expanding humanitarian use of devices

    This section amends Section 520(m) to require that 
applicants seeking a humanitarian exemption for a device must 
submit an application which the Secretary must review and 
approve or disapprove within 60 days, unless a scientific 
advisory panel is convened. If the Secretary convenes a 
scientific advisory panel, the final decision must occur within 
120 days of thesubmission of the application to the Secretary. 
The Secretary may suspend or withdraw a humanitarian device exemption 
if any of the conditions for granting the exemption are not being met. 
Also, the Secretary may require a person to demonstrate continued 
compliance with the requirements for the exemption.
    Provisions of current regulations pertaining to 
humanitarian device exemptions which are inconsistent with 
section 6 are rescinded upon enactment, and the Secretary must 
modify these regulations to accord with this section.

Sec. 7. Device standards

    Section 7 of the bill creates a process whereby the 
Secretary will identify and list in the Federal Register all or 
parts of nationally or internationally recognized standards 
upon which regulated persons may rely to satisfy requirements 
under the FFDCA to which such standards are applicable. 
Conformance with listed standards may be demonstrated with 
certifications that devices conform with standards. For 
example, in a premarket notification, a submitter may satisfy 
an electrical safety requirement by certifying conformance to 
IEC-601, assuming such standard is identified and listed by the 
Secretary. Because standards are of substantially greater 
importance in the international regulatory community than 
before, and because they present opportunities for more 
efficient premarket reviews and a greater potential for use of 
accredited organizations, the Committee believes this provision 
will assist the FDA and device manufacturers in facilitating 
premarket clearances. The Committee believes that integration 
of nationally and internationally recognized standards into the 
Secretary's regulatory approach to devices will improve the 
efficiency and the effectiveness of device regulation, without 
expenditure of significant resources.
    An important feature of this provision is that it does not 
create an obligation that any regulated person rely on a listed 
standard. If a regulated person chooses to rely on a listed 
standard to support the clearance of a premarket notification 
device, that device must conform to any listed standard upon 
which the 510(k) submitter relies. Listed standards may be 
compared to guidance documents, since they do not create an 
obligation for either the FDA or the regulated person. However, 
if a person certifies conformance to such a standard, legal 
responsibility will result. The Committee wishes to emphasize 
that regulated persons may rely on other data or information to 
demonstrate compliance with the FFDCA, including other data or 
information that can be used to establish substantial 
equivalence, notwithstanding the existence of an applicable 
listed standard.
    While the Secretary is required to accept self-
certifications, the Secretary may at any time request that the 
underlying data and information be submitted to support the 
certifications and may reject the certification if the 
submitted data and information do not demonstrate compliance 
with the standards identified in the certification. Regulated 
persons are required to preserve data and information relied 
upon in making a certification for a period of two years or for 
the expected design life of the device, whichever is later. The 
Secretary may remove a standard from the list of adopted 
standards if the Secretary determines that the standard is not 
reliable.
    In addition, section 301 is amended to prohibit regulated 
persons from falsifying certifications or withholding 
information that the Secretary might require under new section 
514(c). Also, the Secretary may enforce the FFDCA against 
persons who represent that a device conforms to a listed 
standard and it does not. Such incorrect representations would 
adulterate a device under section 501(e).
    Finally, the Committee wishes to emphasize that listed 
standards are not necessarily special controls within the 
meaning of section 513(a)(1)(B), and they are not special 
controls when non-substantially-equivalent devices are 
initially classified into class II under section 513(f).

Sec. 8. Scope of review

    This section amends Section 513(a)(3), pertaining to device 
classification. For premarket approval applications (PMAs), the 
Secretary shall evaluate the effectiveness of a device on the 
basis of well-controlled investigations, including one or more 
clinical investigations where appropriate. In reviewing PMAs 
under section 515, the Secretary must consider the extent to 
which data that might otherwise be required to determine 
effectiveness might be reduced through reliance on postmarket 
controls.
    Also, the Secretary must meet with a device sponsor within 
30 days of receiving a request to discuss the type of valid 
scientific evidence needed to demonstrate the effectiveness of 
a device. Within 30 days of the meeting, the Secretary must 
provide the applicant with a written specification of the type 
of evidence needed to provide a reasonable assurance that a 
device is effective under the proposed conditions of use. 
Agreements reached between the Secretary and the applicant must 
be reduced to writing and made part of the Secretary's 
administrative record. The written agreement may not be changed 
unless the applicant agrees or the reviewing office director 
makes a written determination, after providing the sponsor with 
an opportunity for a meeting, that a substantial scientific 
issue essential to determining the safety or effectiveness of 
the device has been identified.
    The amendments to section 513(a)(3) are intended to 
facilitate early and binding determinations of the type of 
scientific evidence necessary to establish a reasonable 
assurance of effectiveness for class III devices which require 
premarket approval. As introduced on May 22, 1997, the original 
H.R. 1710 provision stated, in relevant part: ``Any clinical 
data * * * 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 effectiveness are available that 
would have a reasonable likelihood of resulting in approval.'' 
(Emphasis added). The intention of this original language, 
which also would not have changed the effectiveness standard, 
was to make clear that the FDA should avoid unnecessary over-
regulation of the approval of breakthrough medical devices. In 
deciding to delete the ``no other less burdensome'' language, 
the Committee did not disagree with the intent of the original 
provision; rather the Committee agreed that clear legislative 
history would ensure the same result without creating a 
perception in statute that avoiding a perceived regulatory 
``burden'' is as important as ensuring the safety and 
effectiveness of a medical device.
    The Committee believes that the amendments to section 
513(a)(3) are necessary to and consistent with improving 
communications between the FDA and regulated persons, 
increasing regulatory efficiency, and decreasing the length of 
product review and approval. In particular, the Committee is 
aware of examples where the FDA has requested inappropriate 
types of clinical testing for certain breakthrough devices and 
is concerned about instances in which the agency has required 
sponsors to conduct unnecessary randomized clinical studies to 
demonstrate device effectiveness. Although randomized clinical 
testing may be the best means of demonstrating device 
effectiveness for some products, the Committee is informed that 
such testing is often unnecessary to demonstrate effectiveness 
for many devices.
    Section 513(i) is amended to direct the Secretary to 
consider the extent to which postmarket controls may expedite 
medical device classification. The provision clarifies that 
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. Also, in making such a request, the Secretary 
shall consider the least burdensome means of demonstrating 
substantial equivalence.
    New section 513(i)(1)(E) provides that the Secretary's 
determination of the intended use of a device for purposes of 
determining substantial equivalence with a legally marketed 
device must be based upon the proposed labeling submitted by 
the manufacturer in a 510(k) report unless there is a 
reasonable likelihood that the device will be used for an 
intended use not identified in the proposed labeling and that 
such use could cause harm. Under such circumstances, this 
provision requires the Director of the Office of Device 
Evaluation to provide an opportunity to the submitter of the 
report for consultation about these concerns and to notify the 
submitter within 10 days following that consultation of the 
Director's determination that the unlabeled use could cause 
harm. The provision also clarifies the authority of the 
Secretary to require the label of the device to carry a warning 
or contraindication with respect to the unlabeled use the 
Director has determined could cause harm. Finally, the 
provision requires the Secretary to clear the device for the 
labeled intended use, so long as that labeled use and the 
technological characteristics of the device satisfy the 
requirements for establishing substantial equivalence under 
section 513(i)(1)(A).
    Section 513(i)(1)(E) is most likely to apply to situations 
where a technological change in the device provides the 
Director responsible for clearing the device with reason to 
believe that the device will be used for a use that has not 
been identified on the proposed label, and for which there are 
no, or insufficient, data to establish the safety and 
effectiveness of that device for the unlabeled use.
    Under section 513(i)(1)(E), a device that is substantially 
equivalent to a legally marketed predicate for its labeled 
intended use cannot be kept off the market merely because the 
agencyhas concerns about the harm that could result from an 
unlabeled use. The Director may, however, require limitations in the 
labeling that proscribe the unlabeled use. The Committee believes this 
provision strikes the proper balance between getting devices to the 
market efficiently and protecting the public from harm that may be 
associated with other uses of the device for which there are not data 
establishing safety and effectiveness. The determination that 
limitations about an unlabeled use should be included in labeling for a 
device must be made by the Director of the Office of Device Evaluation 
or a higher level official and cannot be delegated to any employee of 
lesser authority. The Committee believes this level of review is 
essential to ensure that such limitations are required only in those 
circumstances when there is reason to believe, either on the basis of 
data or because of the absence of data, that the use of the device for 
its unlabeled use could cause harm. If the manufacturer of the device 
wishes to have the limiting language removed from the label, the 
manufacturer will be required to file an additional report under 
section 510(k) or a premarket approval application, depending upon the 
nature of the unlabeled use.
    The provision establishing new section 513(i)(1)(E) sunsets 
in five years. At the end of that time period, Congress, the 
industry, the FDA, and the public will be able to determine 
whether this provision has helped to get devices to market more 
efficiently and with adequate public health protection.
    Section 515(d) is amended to specify conditions for 
determining whether to approve or deny a premarket approval 
application (PMA). In making the determination whether to 
approve or deny a PMA, the Secretary must rely on the 
conditions of use included in the proposed labeling unless the 
proposed labeling is false or misleading.
    Under new section 515(d)(6)(A)(i), a supplemental 
application shall be required for any change to a device 
subject to an approved PMA that affects safety or 
effectiveness, unless such change is a modification in a 
manufacturing procedure or method of manufacturing and the 
holder of the approved application submits a written notice to 
the Secretary that describes the change, summarizes the data or 
information supporting the change, and informs the Secretary 
that the change has been made under good manufacturing 
practices. The holder of an approved application who submits a 
notice to modify a device under clause (i) may distribute the 
device within 30 days of notifying the Secretary unless the 
Secretary notifies the applicant that further action is 
required to accept the change. If a premarket approval 
supplement is required, the Secretary must review the 
supplement within 135 days.
    Under new section 515(d)(6)(B), if a supplement for an 
incremental change to the design of a device affects the safety 
and effectiveness of a device, the supplement must be approved 
if nonclinical data demonstrate that the design modification 
enhances device function, and clinical data provide a 
reasonable assurance of safety and effectiveness for the 
changed device.
    This section is intended by the Committee to provide for a 
predictable and dependable structure through which the FDA and 
sponsors of applications for marketing of new products can 
communicate effectively regarding requirements that must be met 
to secure marketing clearance or approval. The Committee 
believes that meetings between the appropriate FDA experts and 
their industry counterparts may provide one avenue to 
successful communication that may result in agreements that can 
expedite a manufacturer's understanding of what information, 
data, or investigations may be needed for any particular 
product. The legislation requires that such meetings be held 
upon the reasonable request of a sponsor or applicant, within a 
specified time frame after such request. By ``reasonable 
request,'' the Committee means that the person requesting the 
meeting must be adequately prepared so that the meeting can be 
productive. Specifically, the person requesting the meeting 
must provide to the FDA a detailed description of the person's 
proposal (whether for clinical protocols or for other studies), 
a detailed description of the person's intended use of the 
product, a proposed plan for completion of studies to 
demonstrate the safety and effectiveness of the product, and 
any other available information about the product that will 
assist FDA experts in providing useful advice and guidance. In 
addition, the person requesting the meeting should provide the 
FDA with the names of all individuals who will represent the 
sponsor or applicant at the meeting, and the position those 
individuals hold in the company or institution.
    The provisions of this section also make clear that the 
FDA, when it has been provided with sufficient information by 
the sponsor or applicant, must respond to meeting requests 
promptly and be prepared to participate in such meetings with a 
view toward reaching the desired conclusion--an agreement 
between the agency and the sponsor or applicant about the data, 
information, or studies needed before marketing approval or 
clearance can be achieved. The Committee intends that when FDA 
officials, including reviewers, provide advice during such 
meetings, and such advice results in an agreement between the 
agency and the sponsor or applicant, the agreement should be 
communicated in writing by the FDA to the sponsor or applicant, 
and should be made part of the agency's administrative record 
related to the particular application or product.
    Although the Committee believes that such agreements should 
be binding on both parties, the Committee also recognizes that 
changes in medical or scientific information, which have a 
direct impact on issues that may have been part of the 
agreement, may occur after the agreement has been reached. In 
addition, the Committee recognizes that, despite everyone's 
best efforts to provide and consider all available information 
at the time of the meeting, there may have been information not 
known to or considered by the FDA (or to the sponsor or 
applicant) which has direct bearing on a decision or agreement 
made at the meeting. This is why the legislation allows for 
changes in any such agreements, based on the fact that a 
substantial scientific issue has come to light after an 
agreement has been reached, which has a direct bearing on the 
determination of the safety or effectiveness of the product. In 
general, changes also can be made if there is agreement between 
the agency and the sponsor or applicant.

Sec. 9. Premarket notification

    Section 9 amends Section 510(k) to provide device 
applicants with the option of submitting a medical device 
notification to either the Secretary or a person accredited 
under new section 712(a). An accredited person must review 
510(k) notifications and submit a recommendation to the 
Secretary within 60 days. The accreditation program established 
under section 712 expires seven years from the date of 
enactment.
    If a device is exempted from reporting requirements under 
new section 510(l) or is classified into class I under section 
513, a notification is not required. Class I devices which are 
intended to be life-supporting, life-sustaining, substantially 
important to preventing impairment of human health, or which 
present an unreasonable risk of injury, shall not be excluded 
from requirements or reports under section 510(k).
    Within 30 days of enactment, the Secretary must publish a 
list of each type of class II device that is exempt from the 
510(k) requirement. After the notice is published, any person 
may petition the Secretary to exempt a class II device from the 
reporting requirement under section 510(k). The Secretary must 
respond to the petition and allow a 30-day public comment 
period. If the Secretary fails to respond to the petition 
within 120 days, the petition shall be deemed to be granted.
    Section 513(f) directs the Secretary to recognize a request 
for reclassification from an applicant whose device is assigned 
to class III pursuant to a not substantially equivalent order 
and who has filed a 510(k) report, providing that such requests 
are received within 30 days of the initial classification 
order. Upon receiving that request, the Secretary must use 
classification criteria set forth in the FFDCA under 
subsections (A) through (C) of 513(a)(1) within 60 days of 
receiving the request to review and classify the device. Any 
device that is not substantially equivalent to an existing 
device and which is classified into class III may not be 
distributed before it is approved under section 515.
    A determination of initial classification of a device may 
not be withheld because of the applicant's failure to comply 
with any provision of the FFDCA that is unrelated to a 
substantial equivalence decision, including noncompliance with 
good manufacturing practices as set forth in regulations under 
section 520(f) (unless such noncompliance is directly related 
to the safety or effectiveness of the device).
    Section 513(i) is amended such that the Secretary or 
accredited organizations may make a determination of 
substantial equivalence on the basis of ``appropriate clinical 
scientific data.''
     The term ``legally marketed device'' includes any device 
marketed before May 28, 1976, and any device found 
substantially equivalent to a device that has not been removed 
from the market for safety or effectiveness reasons.
    Within 270 days of enactment, the Secretary must issue 
guidance specifying the principles that will be considered in 
determining when a specific intended use of a device is not 
reasonably included within a general use of such device for 
purposes of determining substantial equivalence.

Sec. 10. Classification panels

    Under amended section 513(b), the Secretary must convene 
classification panels at such times as to maintain compliance 
with applicable statutory deadlines. Device sponsors have the 
same rights as the Secretary for (i) accessing data and 
information submitted to the classification panel (except for 
information unavailable to the public under section 552 of 
Title 5, United States Code); (ii) submitting written 
information to a classification panel for an application 
submitted under section 515, so long as the information is 
based on the application being considered by the panel (such 
information will be submitted to the Secretary for prompt 
transmittal to the panel); and (iii) participating at panel 
meetings. Classification panels must provide adequate time for 
initial presentations and for responses to different views by 
sponsors. After receiving recommendations and conclusions from 
the classification panel, the Secretary must make a final 
decision on the matter in accordance with section 515(d)(2), 
and must provide written notification to the regulated persons 
affected by the decision. A scientific advisory panel shall not 
be subject to annual chartering and annual reporting 
requirements under the Federal Advisory Committee Act.

Sec. 11. Premarket approval

    Section 11 amends section 515(d) (as amended by section 5) 
by inserting after paragraph (1) a provision for timely medical 
device review. Upon request, the Secretary must meet with an 
applicant who files a premarket approval application within 90 
days of the date the application is submitted. The Secretary 
must review the application and achieve final action within 180 
days of receipt.

Sec. 12. Accreditation for accredited persons

    Section 12 amends Subchapter A of Chapter VII by adding a 
new section 712 which establishes requirements for 
accreditation. Under new section 712, the Secretary must, 
within one year of enactment, accredit persons who will review 
and initially classify devices that are subject to a report 
under section 510(k) of the FFDCA. An accredited person may not 
review a class III device, or class II device that is 
permanently implantable, life-sustaining or life-supporting.
    New section 712(b)(1) directs the Secretary to establish 
through the FDA, or other government agencies or other 
qualified nongovernment agencies, a program for accreditation. 
The Committee emphasizes that the numbers of accredited bodies 
and the kinds of expertise of such bodies will be a function of 
the Secretary's ability to complete the accreditation process, 
as well as of the numbers and kinds of organizations that seek 
accreditation. The Committee does not anticipate that 
accredited organizations will immediately be available for the 
review of every type of medical device eligible under this bill 
for review by accredited bodies. However, the Committee does 
expect the Secretary to proceed promptly and diligently with 
accrediting appropriate, qualified organizations so that this 
pilot program can provide the broadest and most useful 
information.
    Within 180 days of enactment, the Secretary must establish 
and publish in the Federal Register requirements to accredit or 
deny accreditation to persons who request such accreditation. 
The Secretary must respond to a request for accreditation 
within 60 days of receiving the request and include a 
specification of the activities for which the person is 
accredited. When an accredited person acts in a manner 
inconsistent with accreditation purposes or poses a threat to 
public health, accreditation status may be withdrawn from the 
person after that person has been served notice and provided 
with an opportunity for an informal hearing. To ensure that 
accredited persons meet standards of accreditation, the 
Secretary is required to (i) make periodic onsite visits to the 
accredited persons to conduct performance audits, and (ii) take 
additional measures as deemed appropriate.
    Minimum qualifications for accredited persons are (A) 
independence from ownership of or control by a medical device 
affiliate; (B) legal authority to conduct the activities for 
which they seek accreditation; (C) no engagement in the design, 
manufacture, promotion, or sale of devices; and (D) operation 
in accordance with generally accepted professional and ethical 
business practices. The accredited person must agree in writing 
that it will (i) certify that reported information accurately 
reflects data reviewed; (ii) confine its work to those areas in 
which it is competent; (iii) treat information received through 
the pilot program, such as records, reports, and 
recommendations, as proprietary information; (iv) promptly 
respond to and resolve complaints for the activities for which 
it is accredited; and (v) take steps to protect against the use 
of employees who have a financial conflict of interest 
regarding a device, and each year publicly disclose the extent 
to which the organization has complied with financial conflict 
of interest requirements.
    The Secretary must provide applicants with a choice of at 
least two or more accredited persons from which to choose. The 
Committee recognizes that such choices may not be available 
immediately for all types of products, and will be available 
when and to the extent that it has been possible for the 
Secretary to promptly and diligently accredit appropriate 
expert organizations.
    Section 12(b) amends section 301 as amended by new section 
7(b) with a conforming amendment. Additional prohibited acts 
relating to the accreditation program under the FFDCA include 
(A) the submission of a false or misleading report or 
recommendation by an accredited person; (B) the unauthorized 
disclosure of confidential commercial information or any trade 
secrets; and (C) the receipt of a bribe in any form or the 
doing of any corrupt act by an accredited person.
    The amendments establishing the accreditation program under 
the FFDCA shall remain in effect for a period of seven years 
from the date of enactment. Within five years of enactment, the 
Comptroller General of the United States must report to House 
Committee on Commerce and the Senate Committee on Labor and 
Human Resources on the service of accredited persons and the 
extent to which such service was beneficial and/or contrary to 
the purposes of the FFDCA.

Sec. 13. Preamendment devices

    Section 13 amends section 515(i) to direct the Secretary to 
publish in the Federal Register within six months of enactment 
a list of the types of devices classified into class III under 
section 513(d) which are not subject to regulation under 
section 515(b) (that is, which have not been required to submit 
a premarket approval application). Each type of device listed 
in the Federal Register shall be reclassified into class II or 
class I, as appropriate.

Sec. 14. Device tracking

    Section 14 amends section 519 to authorize the Secretary to 
require a manufacturer to track a class II or class III device 
(1) the failure of which would be reasonably likely to have 
serious adverse health consequences, or (2) which is intended 
to be an implantable device or is a life-sustaining or life-
supporting device used outside of a device user facility.

Sec. 15. Postmarket surveillance

    Section 15 amends section 522 of the FFDCA to establish 
that the Secretary has the discretion to order a manufacturer 
to conduct postmarket surveillance for any class II or class 
III device (1) the failure of which would be reasonably likely 
to have serious adverse health consequences, or (2) which is 
intended to be an implantable device or is a life-sustaining or 
life-supporting device used outside of a device user facility.
    Each manufacturer who is required to conduct postmarket 
surveillance of a device must submit a plan within 30 days of 
receiving an order from the Secretary. Within 60 days of 
receiving the postmarket surveillance plan from the 
manufacturer, the Secretary shall determine if the person 
designated to conduct the surveillance is qualified to do so, 
and if the plan will yield the information needed to determine 
the occurrence of unforeseen events. The Secretary, in 
consultation with the manufacturer, may order a surveillance 
period of up to 36 months. Any determination by the Secretary 
that a longer period is necessary shall be made by mutual 
agreement between the Secretary and the manufacturer or, if no 
agreement can be reached, after the completion of a dispute 
resolution process as described in section 3 (``Dispute 
Resolution'') of the bill.

Sec. 16. Harmonization

    This section amends Section 520(f)(1)(B) to ensure that 
regulations for good manufacturing practices conform, to the 
extent practicable, with internationally recognized standards 
defining quality systems, or parts thereof, for medical 
devices.
    Section 803 is amended to require that the Secretary 
participate in multinational meetings to discuss methods and 
approaches to reduce the burden of regulation, harmonize 
regulatory requirements, and seek appropriate reciprocal 
arrangements consistent with the purposes of theFFDCA. Within 
180 days of enactment, the Secretary must publish a plan that 
establishes a framework for achieving mutual recognition of good 
manufacturing practices inspections.
    The Secretary shall report to the House Committee on 
Commerce and the Senate Committee on Labor and Human Resources 
at least 60 days before executing any bilateral or multilateral 
agreement.

Sec. 17. Reports

    Section 17 amends Section 519 to reduce the reporting 
requirements for all distributors of devices. Manufacturers and 
importers, however, are required to comply with the existing 
requirements for medical device reporting. The amendment to 
section 519(a)(9) requires distributors to keep records and 
make them available to the Secretary on request. Because 
distributors will no longer be submitting reports to the 
Secretary, copies of reports would also not be sent to the 
manufacturers. This is not intended to provide the FDA with any 
new statutory authority to require distributors to keep 
additional records; it merely clarifies that existing record 
keeping requirements of section 519(a) continue to apply. This 
provision also removes the registration, listing, and reporting 
requirements for distributors under section 510. Since user 
facilities and manufacturers submit medical device reports to 
the FDA, there is no need for additional reporting by 
distributors. The FDA is urged to allow all record keeping, 
including distributor record keeping, to be accomplished 
through either electronic means or written documentation. The 
FDA is also urged to revise its current regulations on 
distributor record keeping (21 C.F.R. Sec. 804.35(b)) to 
provide that distributors need only keep records of complaints 
for six years from the date a complaint is received by the 
distributor, consistent with the longest statutes of 
limitations under State tort laws. Currently, FDA regulations 
require distributors to keep records for two years from the 
date of the record of complaint or the expected life of the 
device, whichever is greater. It is the intent of the Committee 
to simplify these requirements, since distributors, unlike 
manufacturers, are not able to determine the expected life of a 
device. Since these records will be kept by manufacturers as 
well, it is unnecessarily burdensome for distributors to keep 
these records for other than a fixed period of time.
    The Committee expects the FDA to modify its regulations 
under section 519(f) to ensure that the reports under this 
section are not required from any manufacturer, importer, or 
distributor who also is regulated and required to make such 
reports under the Radiation Control for Health and Safety Act 
of 1968 (21 U.S.C. 360ll).
    Section 519(b) is amended by changing user reporting 
requirements from semi-annual to annual, and by adding a 
requirement that the Secretary plan and implement a sentinel 
system under which the Secretary limits user reporting to a 
subset of hospitals and nursing homes that constitute a 
representative profile of user reports for device deaths and 
serious illnesses or serious injuries. Within one year of 
enactment, the Secretary must submit a report to the House 
Committee on Commerce and the Senate Committee on Labor and 
Human Resources describing the plan for the sentinel system and 
the progress that has been made toward its implementation. The 
Committee expects the Secretary to proceed promptly and 
diligently toward establishing such a sentinel system.
    The Committee requests that the Secretary, in consultation 
with the National Institute for Occupational Safety and Health, 
the FDA, medical experts, and manufacturers, conduct a study of 
topically applied allergenic products used for the diagnosis of 
Type IV allergies (patch tests). To the extent feasible, the 
report should: (1) examine the extent of allergic skin 
reactions and contact dermatitis in the workplace; (2) assess 
the current availability of topically applied allergenic 
products used for the diagnosis of Type IV allergies (patch 
tests), compared with their availability in the 1980s and with 
availability in other countries; and (3) list by year, since 
1970, the number of adverse reaction reports filed with the FDA 
resulting from the use of topically applied allergenic products 
used for the diagnosis of Type IV allergies and describe, to 
the extent possible, whether those adverse reactions resulted 
from commercial allergens or allergens that were individually 
prepared by a patient, physician, pharmacist, or other person. 
The Committee requests that the Secretary submit a report on 
the results of this study to the House Committee on Commerce 
and the Senate Committee on Labor and Human Resources not later 
than one year after enactment of this bill.

Sec. 18. Information system

    Section 18 amends Chapter IX by adding new section 906 
(``Information System'') which requires the Secretary to 
establish an information system to track the status and 
progress of each application or submission that is submitted to 
the FDA for action. Device applicants shall be granted access 
to that system under conditions specified by the Secretary. The 
Committee recognizes that access to such a system must be 
carefully constructed to avoid inappropriate disclosure of 
confidential commercial information.

Sec. 19. Practice of medicine

    Section 19 adds to Chapter IX a new section, Sec. 907. 
Practice of Medicine, to clarify that provisions in the FFDCA 
do not limit or interfere with the authority of a licensed 
health care practitioner to prescribe or administer any legally 
marketed drug or device in the context of a legitimate health 
care practitioner-patient relationship. This section does not 
limit any existing authority of the Secretary to establish and 
enforce restrictions on the sale or distribution, or in the 
labeling, of a device that are part of a determination of 
substantial equivalence, established as a condition of 
approval, or promulgated through regulations. Further, this 
section does not change any existing prohibition on the 
promotion of unapproved uses of legally marketed devices.
    The Committee intends by this provision to emphasize that 
the FDA should not interfere in the practice of medicine. 
Specifically, the Committee notes that the uses of a medical 
device not covered by the label, by a physician using best 
medical judgment in determining how and when to use a medical 
product for the care of a particular patient, is not the 
province of the FDA. The Committee has clarified that the FDA's 
current authority to place restrictions on thelabeling of a 
product, which may deal with the training or other requirements needed 
to use the device safely and effectively, is not limited by this 
provision. However, the Committee does not intend by this clarification 
to sanction or encourage the involvement of the FDA in disputes or 
differences among medical specialists about who may or may not use 
specific medical products. Further, the Committee notes that promotion 
restrictions do not apply to physicians' publishing articles regarding 
off-label uses of products, or presenting information at scientific or 
medical meetings. Finally, the Committee notes that with respect to 
products already on the market, any restrictions on such products which 
may be in their labeling or which may have been placed on the products 
by virtue of conditions of approval or regulations issued by the 
Secretary are not affected by this provision.

Sec. 20. Clarification of definition

    This section amends Section 201(h) to clarify that a 
computer software product is not to be regulated as a device 
solely on the basis that the primary use of the product is 
related to the provision of health care. Software that is used 
simply to archive patient record information or to serve a 
similar library function will not be considered to be a medical 
device, even when such software is used in a hospital and other 
health care settings. However, nothing in this provision is 
intended to limit the FDA's authority to regulate software that 
is used to diagnose, treat, or prevent diseases or other 
conditions. For example, software that would be used in a 
hospital to identify compatible blood prior to transfusion 
would continue to be considered to be a medical device, as 
would other software that modifies information in patient 
records, such as picture archiving and compression systems. It 
is not the Committee's intention to shift the burden from the 
manufacturer to the FDA to demonstrate that a device, including 
stand-alone software, is safe and effective.

Sec. 21. Labeling and advertising regarding compliance with statutory 
        requirements

    Section 21 repeals section 301(l), which prohibits the use 
of any representation or suggestion that a device or drug is 
approved in accordance with the FFDCA.

Sec. 22. Noninvasive blood glucose meter

    This section expresses the sense of Congress that the 
availability of a safe, effective, noninvasive blood glucose 
meter would greatly enhance the health and well-being of all 
people with diabetes across America and the world.

Sec. 23. Rule of construction

    Whether and to what extent, if any, the FDA has authority 
under the FFDCA to regulate tobacco products, tobacco product 
ingredients, or tobacco product additives are questions 
currently under review by the courts. See Coyne Beahm, Inc. v. 
United States Food & Drug Administration, 958 F. Supp. 1060 
(M.D. N.C. 1997), appeals pending, No. 97-1604 (and 
consolidated cases) (4th Cir.). During the deliberations on 
H.R. 1710, concern was expressed that the amendments to the 
FFDCA made by the legislation might be deemed to affect the 
extent of any FDA authority with respect to tobacco products, 
if the courts ultimately uphold the agency's assertion of 
authority to regulate tobacco products. To respond to that 
concern, a section stating a ``rule of construction'' has been 
included in H.R. 1710 to make clear that Congress, through this 
legislation, is taking no position regarding either whether the 
FDA has any authority under the FFDCA to regulate any tobacco 
product, or what the extent of any such authority may be. 
Further, this section ensures that, if the courts ultimately 
determine that the FDA has authority under existing law to 
regulate tobacco products, this legislation does not alter any 
such authority as it may have existed when the FDA adopted its 
tobacco rule, as any such authority may ultimately be construed 
by the courts.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3 of rule XIII of the Rules of the 
House of Representatives, changes in existing law made by the 
bill, as reported, are shown as follows (existing law proposed 
to be omitted is enclosed in black brackets, new matter is 
printed in italic, existing law in which no change is proposed 
is shown in roman):

                  FEDERAL FOOD, DRUG, AND COSMETIC ACT

          * * * * * * *

                        CHAPTER II--DEFINITIONS

          * * * * * * *
  Sec. 201. For the purposes of this Act--
  (a) * * *
          * * * * * * *
  (h) The term ``device'' (except when used in paragraph (n) of 
this section and in sections 301(i), 403(f), 502(c), and 
602(c)) means an instrument, apparatus, implement, machine, 
contrivance, implant, in vitro reagent, or other similar or 
related article, including any component, part, or accessory, 
which is--
          (1) * * *
          * * * * * * *
which does not achieve its primary intended purposes through 
chemical action within or on the body of man or other animals 
and which is not dependent upon being metabolized for the 
achievement of its primary intended purposes. A computer 
software product shall not be considered a device under this 
paragraph solely on the basis that the primary use of such 
product is related to the provision of health care.
          * * * * * * *

               CHAPTER III--PROHIBITED ACTS AND PENALTIES

  Sec. 301. The following acts and the causing thereof are 
hereby prohibited:
  (a) * * *
          * * * * * * *
  [(l) The using, on the labeling of any drug or device or in 
any advertising relating to such drug or device, of any 
representation or suggestion that approval of an application 
with respect to such drug or device is in effect under section 
505, 515, or 520(g), as the case may be, or that such drug or 
device complies with the provisions of such section.]
          * * * * * * *
  (x) The falsification of a certification under section 514(c) 
or the failure or refusal to provide data or information 
required by the Secretary under such section.
  (y) In the case of a drug, device, or food--
          (1) the submission of a report or recommendation by a 
        person accredited under section 712 that is false or 
        misleading in any material respect;
          (2) the disclosure by a person accredited under 
        section 712 of confidential commercial information or 
        any trade secret without the express written consent of 
        the person who submitted such information or secret to 
        such person; or
          (3) the receipt by a person accredited under section 
        712 of a bribe in any form or the doing of any corrupt 
        act by such person associated with a responsibility 
        delegated to such person under this Act.
          * * * * * * *

                      CHAPTER V--DRUGS AND DEVICES

                    Subchapter A--Drugs and Devices

                     adulterated drugs and devices

  Sec. 501. A drug or device shall be deemed to be 
adulterated--
  (a) * * *
          * * * * * * *
  (e) If it is, or purports to be or is represented as, a 
device which is [subject to a performance standard established 
under section 514, unless such device is in all respects in 
conformity with such standard.] subject to a performance 
standard established under subsection (b) of section 514, 
unless such device is in all respects in conformity with such 
standard; or subject to a standard listed under subsection (c) 
of such section (in the case of a person who has self-certified 
to such standard), unless such device is in all respects in 
conformity with such standard.
          * * * * * * *


                           dispute resolution


  Sec. 506A. If, regarding an obligation under this Act, there 
is a scientific controversy between the Secretary and a person 
who is a sponsor, applicant, or manufacturer, and no specific 
provision of this Act or regulation promulgated under this Act 
provides a right of review of the matter in controversy, the 
Secretary shall, by regulation, establish a procedure under 
which such sponsor, applicant, or manufacturer may request a 
review of such controversy by an appropriate scientific 
advisory panel under section 515(g)(2)(B). Such review shall 
take place in a timely manner. The Secretary shall promulgate 
such regulations not later than 180 days after the date of the 
enactment of the Medical Device Regulatory Modernization Act of 
1997.
          * * * * * * *
  Sec. 510. (a) * * *
          * * * * * * *
  (g) The foregoing subsections of this section shall not apply 
to--
          (1) * * *
          * * * * * * *
          (4) any distributor who acts as a wholesale 
        distributor of devices, and who does not manufacture, 
        repackage, process, or relabel a device; or
          [(4)] (5) such other classes of persons as the 
        Secretary may by regulation exempt from the application 
        of this section upon a finding that registration by 
        such classes of persons in accordance with this section 
        is not necessary for the protection of the public 
        health.
In this subsection, the term ``wholesale distributor'' means 
any person who distributes a device from the original place of 
manufacture to the person who makes the final delivery or sale 
of the device to the ultimate consumer or user.
          * * * * * * *
  (k) Each person who is required to register under this 
section and who proposes to begin the introduction or delivery 
for introduction into interstate commerce for commercial 
distribution of a device intended for human use shall, at least 
ninety days before making such introduction or delivery, report 
to the Secretary or person who is accredited under section 
712(a) (in such form and manner as the Secretary shall by 
regulation prescribe)--
          (1) * * *
          * * * * * * *
Such a report is not required for a device intended for human 
use that is exempted from the requirements of this subsection 
under subsection (l) or is classified into class I under 
section 513. The exception established in the preceding 
sentence does not apply to any class I device that is intended 
to be life supporting or life sustaining or is intended for a 
use which is of substantial importance in preventing impairment 
of human health, or to any class I device that presents a 
potential unreasonable risk of illness or injury. With respect 
to a person who is accredited under section 712(a), such 
accredited person shall review a report under this subsection 
that is received by such person and shall submit, not later 
than 60 days after receiving the report, to the Secretary such 
person's recommendation for action to be taken by the Secretary 
on the report.
  (l) Not later than 30 days after the date of the enactment of 
the Medical Device Regulatory Modernization Act of 1997, the 
Secretary shall 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 listed by the 
Secretary 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. Beginning on the date that is 1 
day after the date of the publication of the list, any person 
may petition the Secretary to exempt a type of class II device 
from the reporting requirement of subsection (k). The Secretary 
shall publish in the Federal Register notice of the intent of 
the Secretary to exempt the device, or of the petition, and 
provide a 30-day period for publiccomment. If the Secretary 
fails to respond to a petition within 120 days of receiving it, the 
petition shall be deemed to be granted.
          * * * * * * *

            classification of devices intended for human use

                             Device Classes

    Sec. 513. (a)(1) There are established the following 
classes of devices intended for human use:
          (A) * * *
          (B) Class ii, special controls.--A device which 
        cannot be classified as a class I device because the 
        general controls by themselves are insufficient to 
        provide reasonable assurance of the safety and 
        effectiveness of the device, and for which there is 
        sufficient information to establish special controls to 
        provide such assurance, including the promulgation of 
        performance standards, the listing of standards under 
        section 514(c), postmarket surveillance, patient 
        registries, development and dissemination of guidelines 
        (including guidelines for the submission of clinical 
        data in premarket notification submissions in 
        accordance with section 510(k)), recommendations, and 
        other appropriate actions as the Secretary deems 
        necessary to provide such assurance. For a device that 
        is purported or represented to be for a use in 
        supporting or sustaining human life, the Secretary 
        shall examine and identify the special controls, if 
        any, that are necessary to provide adequate assurance 
        of safety and effectiveness and describe how such 
        controls provide such assurance.
          * * * * * * *
  (3)(A) Except as authorized by subparagraph (B), the 
effectiveness of a device is, for purposes of this section and 
sections 514 and 515, to be determined, in accordance with 
regulations promulgated by the Secretary, on the basis of well-
controlled investigations, including one or more clinical 
investigations where appropriate, by experts qualified by 
training and experience to evaluate the effectiveness of the 
device, from which investigations it can fairly and responsibly 
be concluded by qualified experts that the device will have the 
effect it purports or is represented to have under the 
conditions of use prescribed, recommended, or suggested in the 
labeling of the device.
          * * * * * * *
  (C) In making a determination of a reasonable assurance of 
the effectiveness of a device for which an application under 
section 515 has been submitted, the Secretary shall consider 
whether the extent of data that otherwise would be required for 
approval of the application with respect to effectiveness can 
be reduced through reliance on postmarket controls.
  (D)(i) Upon the request of any person intending to submit an 
application under section 515, the Secretary shall, not later 
than 30 days after receiving such request, 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 proposed 
conditions of use. Within 30 days of such meeting, the 
Secretary shall identify, and confirm in writing, the type of 
valid scientific evidence that will provide a reasonable 
assurance that a device is effective under the proposed 
conditions of use.
  (ii) Agreements under section 515 regarding the parameters of 
valid scientific evidence for a device that are reached between 
the Secretary and a sponsor or applicant shall be reduced to 
writing and made part of the administrative record by the 
Secretary. Such agreements shall not be changed, except--
          (I) with the written agreement of the sponsor or 
        applicant; or
          (II) pursuant to a decision, made in accordance with 
        clause (iii) by the director of the office in which the 
        device involved is reviewed, that a substantial 
        scientific issue essential to determining the safety or 
        effectiveness of the device has been identified.
  (iii) A decision under clause (ii) by the director shall be 
in writing, and may be made only after the Secretary has 
provided to the sponsor or applicant an opportunity for a 
meeting at which the director and the sponsor or applicant are 
present and at which the director documents the scientific 
issue involved.
  (b)(1) * * *
          * * * * * * *
  (5) Classification panels covering each type of device shall 
be scheduled to meet at such times as may be appropriate for 
the Secretary to meet applicable statutory deadlines.
  (6)(A) Any person whose device is specifically the subject of 
review by a classification panel shall have the same rights as 
the Secretary regarding--
          (i) access to data and information submitted to a 
        classification panel (except for data and information 
        that are not available for public disclosure under 
        section 552 of title 5, United States Code);
          (ii) the submission, for review by a classification 
        panel, of information that is based on the data or 
        information provided in the application submitted under 
        section 515 by the person, which information shall be 
        submitted to the Secretary for prompt transmittal to 
        the classification panel; and
          (iii) the participation of the persons at meetings of 
        the panel.
  (B) Any meetings of a classification panel shall provide 
adequate time for initial presentations and for response to any 
differing views by persons whose devices are specifically the 
subject of a classification panel review, and shall encourage 
free and open participation by all interested persons.
  (7) After receiving from a classification panel the 
conclusions and recommendations of the panel on a matter that 
the panel has reviewed, the Secretary shall review the 
conclusions and recommendations, shall make a final decision on 
the matter in accordance with section 515(d)(2), and shall 
notify the affected persons of the decision in writing and, if 
the decision differs from the conclusions and recommendations 
of the panel, shall include the reasons for the difference.
  (8) A scientific advisory panel under this subsection shall 
not be subject to the annual chartering and annual report 
requirements of the Federal Advisory Committee Act.
          * * * * * * *
  (f)(1) Any device intended for human use which was not 
introduced or delivered for introduction into interstate 
commerce for commercial distribution before the date of the 
enactment of this section is classified in class III unless--
          (A) the device--
                  (i) is within a type of device (I) which was 
                introduced or delivered for introduction into 
                interstate commerce for commercial distribution 
                before such date and which is to be classified 
                pursuant to subsection (b), or (II) which was 
                not so introduced or delivered before such date 
                and has been classified in class I or II, and
                  (ii) is substantially equivalent to another 
                device within such type, or
          (B) the Secretary in response to a petition submitted 
        under paragraph (2) has classified such device in class 
        I or II.
A device classified in class III under this paragraph shall be 
classified in that class until the effective date of an order 
of the Secretary under paragraph (2) classifying the device in 
class I or II[.] unless within 30 days of receiving an order 
classifying the device into class III the person who submits a 
report under section 510(k) for such device requests review 
with respect to the classification of the device and a final 
order of classification from the Secretary. Such person shall 
submit to the Secretary data and information supporting the 
classification of the device into class I or II. After the 
request, a device classified into class III under this 
paragraph remains in class III, but shall not be deemed to be 
finally classified until the Secretary has determined the 
classification of the device based on the classification 
criteria set forth in subparagraphs (A) through (C) of 
subsection (a)(1), within 60 days of receiving the request to 
review and classify a device. Any device found under this 
paragraph not to be substantially equivalent to a device 
described in subparagraph (A)(i) and which is classified by the 
Secretary into Class III may not be commercially distributed in 
commerce before it is approved under section 515.
          * * * * * * *
  (4) The Secretary may not withhold a determination of the 
initial classification of a device under paragraph (1) because 
of a failure to comply with any provision of this Act unrelated 
to a substantial equivalence decision, including a finding that 
the facility in which the device is manufactured is not in 
compliance with good manufacturing requirements as set forth in 
regulations of the Secretary under section 520(f) (other than a 
finding that the failure to comply with such regulations is 
directly related to the safety or effectiveness of the device).
          * * * * * * *

                        Substantial Equivalence

    (i)(1)(A) For purposes of determinations of substantial 
equivalence under subsection (f) and section 520(l), the term 
``substantially equivalent'' or ``substantial equivalence'' 
means, with respect to a device being compared to a predicate 
device, that the device has the same intended use as the 
predicate device and that the Secretary by order has found that 
the device--
          (i) has the same technological characteristics as the 
        predicate device, or
          (ii)(I) has different technological characteristics 
        and the information submitted that the device is 
        substantially equivalent to the predicate device 
        contains information, including [clinical data] 
        appropriate clinical or scientific data if deemed 
        necessary by the Secretary or a person accredited under 
        section 712, that demonstrates that the device is as 
        safe and effective as a legally marketed device, and 
        (II) does not raise different questions of safety and 
        [efficacy] effectiveness than the predicate device.
          * * * * * * *
  (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) 
of this section.
  (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 request, 
the Secretary shall consider the least burdensome means of 
demonstrating substantial equivalence and request information 
accordingly.
  (E)(i) Any determination by the Secretary of the intended use 
of a device shall be based upon the proposed labeling submitted 
in a report for the device under section 510(k), unless the 
director of the organizational unit responsible for regulating 
devices (in this subparagraph referred to as the ``Director''), 
after providing an opportunity for consultation with the person 
who submitted such report, determines and states in writing (I) 
that there is a reasonable likelihood that the device will be 
used for an intended use not identified in the proposed 
labeling for the device, and (II) on the basis of data or the 
absence of data, that such use could cause harm.
  (ii) Such determination shall--
          (I) be provided to the person who submitted the 
        report within 10 days from the date of the notification 
        of the Director's concerns regarding the proposed 
        labeling;
          (II) specify limitations on the device's labeling 
        which proscribe the use not included in proposed 
        labeling; and
          (III) find the device substantially equivalent when 
        the labeled intended use and the technological 
        characteristics of the device relative to a legally 
        marketed device conform with the requirements of 
        subparagraph (A).
  (iii) The responsibilities of the Director under this 
subparagraph may not be delegated.
  (iv) This subparagraph has no legal effect after the 
expiration of the five-year period beginning on the date of the 
enactment of the Medical Device Regulatory Modernization Act of 
1997.
  (F) For purposes of subparagraph (A), the term ``legally 
marketed device'' includes any device introduced into 
interstate commerce for commercial distribution before May 28, 
1976, and any device determined to be substantially equivalent 
to such device which has not been removed from the market by an 
order of the Secretary or a judicial order because it is not 
safe or not effective.
  (G) Not later than 270 days after the date of the enactment 
of the Medical Device Regulatory Modernization Act of 1997, the 
Secretary shall issue guidance specifying the general 
principles that the Secretary will consider in determining when 
a specific intended use of a device is not reasonably included 
within a general use of such device for purposes of a 
determination of substantial equivalence under subsection (f) 
or section 520(l).
          * * * * * * *

                         performance standards

                        Provisions of Standards

  Sec. 514. (a)(1) The special controls required by section 
513(a)(1)(B) shall include performance standards for a class II 
device if the Secretary determines that a performance standard 
is necessary to provide reasonable assurance of the safety and 
effectiveness of the device. A class III device may also be 
considered a class II device for purposes of establishing a 
standard for the device [under this section] under subsection 
(b) if the device has been reclassified as a class II device 
under a regulation under section 513(e) but such regulation 
provides that the reclassification is not to take effect until 
the effective date of such a standard for the device.
  (2) A performance standard established [under this section] 
under subsection (b) for a device--
          (A) * * *
          * * * * * * *
  (3) The Secretary shall provide for periodic evaluation of 
performance standards established [under this section] under 
subsection (b) to determine if such standards should be changed 
to reflect new medical, scientific, or other technological 
data.
  (4) In carrying out his duties under [this section] this 
subsection and subsection (b), the Secretary shall, to the 
maximum extent practicable--
          (A) * * *
          * * * * * * *

                    Listing of Recognized Standards

  (c)(1) The Secretary shall issue notices identifying and 
adopting applicable nationally or internationally recognized 
standards (or portions of such standards) to which a person may 
self-certify compliance for the purpose of demonstrating a 
reasonable assurance that a device is safe or effective or to 
determine compliance with any requirement of this Act. Such 
notices shall be published in the Federal Register, and the 
Secretary shall provide an opportunity for public comment on 
the standards involved.
  (2) The Secretary shall accept a certification that a device 
conforms with each type of standard referenced in subsection 
(a) and identified in such certification to the extent such 
standard applies, except that the Secretary may, at any time, 
require the person who submitted the certification to submit 
the data and information which such person relied upon in 
making such certification, and may reject the certification if 
the Secretary determines that the data and information do not 
demonstrate compliance with the standards identified in the 
certification. Such person shall maintain the data and 
information for a period of 2 years after the submission of the 
certification, or for the expected design life of the device, 
whichever is later.
  (3) The Secretary may remove from the list of standards 
adopted under subsection (a) a standard (or portion of a 
standard) which the Secretary determines is not reliable for 
the purpose set out in such subsection.
  (4) In the case of a person who does not self-certify 
compliance pursuant to paragraph (1) regarding a device, the 
person may elect to utilize data other than those required by 
standards under paragraph (1) to demonstrate a reasonable 
assurance of the safety or effectiveness of the device.

                           premarket approval

                          General Requirement

  Sec. 515. (a) * * *
          * * * * * * *

            Action on an Application for Premarket Approval

  (d)(1)(A) As promptly as possible, but in no event later than 
one hundred and eighty days after the receipt of an application 
under subsection (c) (except as provided in section 
520(l)(3)(D)(ii) or unless, in accordance with subparagraph 
(B)(i), an additional period as agreed upon by the Secretary 
and the applicant), the Secretary, after considering the report 
and recommendation submitted under paragraph (2) of such 
subsection, shall--
          (i) issue an order approving the application if he 
        finds that none of the grounds for denying approval 
        specified in paragraph (2) of this subsection applies; 
        or
          (ii) deny approval of the application if he finds 
        (and sets forth the basis for such finding as part of 
        or accompanying such denial) that one or more grounds 
        for denial specified in paragraph (2) of this 
        subsection apply.
In making the determination whether to approve or deny the 
application, the Secretary shall rely on the conditions of use 
included in the proposed labeling as the basis for determining 
whether or not there is a reasonable assurance of safety and 
effectiveness, if the proposed labeling is neither false nor 
misleading. In determining whether or not such labeling is 
false or misleading, the Secretaryshall fairly evaluate all 
material facts pertinent to the proposed labeling.
          * * * * * * *
    (2) Each application received under subsection (c) shall be 
reviewed in a manner to achieve final action on such 
application within 180 days of its receipt. At the request of 
the applicant, the Secretary shall meet with an applicant under 
such an application within 90 days of the date of the 
application's submission.
    [(2)] (3) The Secretary shall deny approval of an 
application for a device if, upon the basis of the information 
submitted to the Secretary as part of the application and any 
other information before him with respect to such device, the 
Secretary finds that--
        (A) * * *
          * * * * * * *
    [(3)] (4) An applicant whose application has been denied 
approval may, by petition filed on or before the thirtieth day 
after the date upon which he receives notice of such denial, 
obtain review thereof in accordance with either paragraph (1) 
or (2) of subsection (g), and any interested person may obtain 
review, in accordance with paragraph (1) or (2) of subsection 
(g), of an order of the Secretary approving an application.
    (5) In order to provide for more effective treatment or 
diagnosis of life-threatening or irreversibly debilitating 
human diseases or conditions, the Secretary shall provide 
review priority for devices--
          (A) representing breakthrough technologies,
          (B) for which no approved alternatives exist,
          (C) which offer significant advantages over existing 
        approved alternatives, or
          (D) the availability of which is in the best interest 
        of the patients.
    (6)(A)(i) A supplemental application shall be required for 
any change to a device subject to an approved application under 
this subsection that affects safety or effectiveness, unless 
such change is a modification in a manufacturing procedure or 
method of manufacturing and the holder of the approved 
application submits a written notice to the Secretary that 
describes in detail the change, summarizes the data or 
information supporting the change, and informs the Secretary 
that the change has been made under the requirements of section 
520(f).
    (ii) The holder of an approved application who submits a 
notice under clause (i) with respect to a manufacturing change 
of a device may distribute the device 30 days after the date on 
which the Secretary receives the notice, unless the Secretary 
within such 30-day period notifies the holder that the notice 
is not adequate and describes such further information or 
action that is required for acceptance of such change. If the 
Secretary notifies the holder that a premarket approval 
supplement is required, the Secretary shall review the 
supplement within 135 days after the receipt of the supplement. 
The time used by the Secretary to review the notice of the 
manufacturing change shall be deducted from the 135-day review 
period if the notice meets appropriate content requirements for 
premarket approval supplements.
    (B)(i) Subject to clause (ii), 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 such supplement if--
          (I) nonclinical data demonstrate that the design 
        modification creates the intended additional capacity, 
        function, or performance of the device; and
          (II) clinical data from the approved application and 
        any supplement to the approved application provide a 
        reasonable assurance of safety and effectiveness for 
        the changed device.
    (ii) The Secretary may require, when necessary, additional 
clinical data to evaluate the design modification of the device 
to provide a reasonable assurance of safety and effectiveness.
          * * * * * * *

                               [Revision

    [(i)(1) Before December 1, 1995, the Secretary shall by 
order require manufacturers of devices, which were introduced 
or delivered for introduction into interstate commerce for 
commercial distribution before May 28, 1976, and which are 
subject to revision of classification under paragraph (2), to 
submit to the Secretary a summary of and citation to any 
information known or otherwise available to the manufacturer 
respecting such devices, including adverse safety or 
effectiveness information which has not been submitted under 
section 519. The Secretary may require the manufacturer to 
submit the adverse safety or effectiveness data for which a 
summary and citation were submitted, if such data are available 
to the manufacturer.
    [(2) After the issuance of an order under paragraph (1) but 
before December 1, 1995, the Secretary shall publish a 
regulation in the Federal Register for each device--
          [(A) which the Secretary has classified as a class 
        III device, and
          [(B) for which no final regulation has been 
        promulgated under section 515(b),
revising the classification of the device so that the device is 
classified into class I or class II, unless the regulation 
requires the device to remain in class III. In determining 
whether to revise the classification of a device or to require 
a device to remain in class III, the Secretary shall apply the 
criteria set forth in section 513(a). Before the publication of 
a regulation requiring a device to remain in class III or 
revising its classification, the Secretary shall publish a 
proposed regulation respecting the classification of a device 
under this paragraph and provide reasonable opportunity for the 
submission of comments on any such regulation. No regulation 
requiring a device to remain in class III or revising its 
classification may take effect before the expiration of 90 days 
from the date of its publication in the Federal Register as a 
proposed regulation.
    [(3) The Secretary shall, as promptly as is reasonably 
achievable, but not later than 12 months after the effective 
date of the regulation requiring a device to remain in class 
III, establish a schedule for the promulgation of a section 
515(b) regulation for each device which is subject to the 
regulation requiring the device to remain in class III.]

                                Revision

    (i) Not later than 180 days after the date of the enactment 
of the Medical Device Regulatory Modernization Act of 1997, the 
Secretary shall publish in the Federal Register a list of the 
types of devices classified into class III under section 
513(d), which are not subject to a regulation under subsection 
(b), and for which the Secretary has determined after 
classification of such devices that premarket approval is 
unnecessary to protect the public health. Each such type of 
device listed in the Federal Register publication shall be 
reclassified into class II or class I, as appropriate.
          * * * * * * *

                     records and reports on devices

                              General Rule

    Sec. 519. (a) Every person who is a [manufacturer, 
importer, or distributor] manufacturer or importer of a device 
intended for human use shall establish and maintain such 
records, make such reports, and provide such information, as 
the Secretary may by regulation reasonably require to assure 
that such device is not adulterated or misbranded and to 
otherwise assure its safety and effectiveness. Regulations 
prescribed under the preceding sentence--
        (1) * * *
          * * * * * * *
          [(9) shall require distributors who submit such 
        reports to submit copies of the reports to the 
        manufacturer of the device for which the report was 
        made.]
          (9) shall require distributors to keep records and 
        make such records available to the Secretary upon 
        request.
In prescribing such regulations, the Secretary shall have due 
regard for the professional ethics of the medical profession 
and the interests of patients. The prohibitions of paragraph 
(7) of this subsection continue to apply to records, reports, 
and information concerning any individual who has been a 
patient, irrespective of whether or when he ceases to be a 
patient.

                              User Reports

    (b)(1)(A) * * *
          * * * * * * *
    (C) Each device user facility shall submit to the Secretary 
on [a semi-annual basis] an annual basis a summary of the 
reports made under subparagraphs (A) and (B). Such summary 
shall be submitted on January 1 [and July 1] of each year. The 
summary shall be in such form and contain such information from 
such reports as the Secretary may require and shall include--
          (i) sufficient information to identify the facility 
        which made the reports for which the summary is 
        submitted,
          (ii) in the case of any product which was the subject 
        of a report, the product name, serial number, and model 
        number,
          (iii) the name and the address of the manufacturer of 
        such device, and
          (iv) a brief description of the event reported to the 
        manufacturer.
[The Secretary may by regulation alter the frequency and timing 
of reports required by this subparagraph.]
          * * * * * * *
    (2) The Secretary may not disclose the identity of a device 
user facility which makes a report under paragraph (1) except 
in connection with--
          (A) an action brought to enforce section 301(q), or
          (B) a communication to a manufacturer of a device 
        which is the subject of a report under paragraph (1)[, 
        or].
          [(C) a disclosure required under subsection (a).]
This paragraph does not prohibit the Secretary from disclosing 
the identity of a device user facility making a report under 
paragraph (1) or any information in such a report to employees 
of the Department of Health and Human Services, to the 
Department of Justice, or to the duly authorized committees and 
subcommittees of the Congress.
          * * * * * * *
    (5) With respect to device user facilities that are 
hospitals or nursing homes:
          (A) The Secretary shall by regulation plan and 
        implement a program under which the Secretary limits 
        user reporting under paragraphs (1) through (4) to a 
        subset of hospitals and nursing homes that constitutes 
        a representative profile of user reports for device 
        deaths and serious illnesses or serious injuries.
          (B) During the period of planning the program under 
        subparagraph (A), paragraphs (1) through (4) continue 
        to apply to such device user facilities.
          (C) During the period in which the Secretary is 
        providing for a transition to the full implementation 
        of the program, paragraphs (1) through (4) apply to 
        such facilities except to the extent that the Secretary 
        determines otherwise.
          (D) On and after the date on which the program is 
        fully implemented, paragraphs (1) through (4) do not 
        apply to such a facility unless the facility is 
        included in the subset referred to in subparagraph (A).
          (E) Not later than one year after the date of the 
        enactment of the Medical Device Regulatory 
        Modernization Act of 1997, the Secretary shall submit 
        to the Committee on Commerce of the House of 
        Representatives, and to the Committee on Labor and 
        Human Resources of the Senate, a report describing the 
        plan developed by the Secretary under subparagraph (A) 
        and the progress that has been made toward the 
        implementation of the plan.
    [(5)] (6) For purposes of this subsection:
          (A) The term ``device user facility'' means a 
        hospital, ambulatory surgical facility, nursing home, 
        or outpatient treatment facility which is not a 
        physician's office. The Secretary may by regulation 
        include an outpatient diagnostic facility which is not 
        a physician's office in such term.
          (B) The terms ``serious illness'' and ``serious 
        injury'' mean illness or injury, respectively, that--
                  (i) is life threatening,
                  (ii) results in permanent impairment of a 
                body function or permanent damage to a body 
                structure, or
                  (iii) necessitates medical or surgical 
                intervention to preclude permanent impairment 
                of a body function or permanent damage to a 
                body structure.
          * * * * * * *

                             [Certification

    [(d) Each manufacturer, importer, and distributor required 
to make reports under subsection (a) shall submit to the 
Secretary annually a statement certifying that--
          [(1) the manufacturer, importer, or distributor did 
        file a certain number of such reports, or
          [(2) the manufacturer, importer, or distributor did 
        not file any report under subsection (a).

                            [Device Tracking

    [(e) Every person who registers under section 510 and is 
engaged in the manufacture of--
          [(1) a device the failure of which would be 
        reasonably likely to have serious adverse health 
        consequences and which is (A) a permanently implantable 
        device, or (B) a life sustaining or life supporting 
        device used outside a device user facility, or
          [(2) any other device which the Secretary may 
        designate,
    shall adopt a method of device tracking.]

                            Device Tracking

    (e) The Secretary may by order require a manufacturer to 
adopt a method of tracking a class II or class III device--
          (1) the failure of which would be reasonably likely 
        to have serious adverse health consequences; or
          (2) which is--
                  (A) intended to be an implantable device, or
                  (B) a life sustaining or life supporting 
                device used outside a device user facility.

                  Reports of Removals and Corrections

    (f)(1) Except as provided in paragraph (2), the Secretary 
shall by regulation require a manufacturer[, importer, or 
distributor] or importer of a device to report promptly to the 
Secretary any correction or removal of a device undertaken by 
such manufacturer[, importer, or distributor] or importer if 
the removal or correction was undertaken--
          (A) to reduce a risk to health posed by the device, 
        or
          (B) to remedy a violation of this Act caused by the 
        device which may present a risk to health.
A manufacturer[, importer, or distributor] or importer of a 
device who undertakes a correction or removal of a device which 
is not required to be reported under this paragraph shall keep 
a record of such correction or removal.
    (2) No report of the corrective action or removal of a 
device may be required under paragraph (1) if a report of the 
corrective action or removal is required and has been submitted 
under subsection (a).
    (3) For purposes of paragraphs (1) and (2), the terms 
``correction'' and ``removal'' do not include routine 
servicing.

general provisions respecting control of devices intended for human use

                              General Rule

    Sec. 520. (a) * * *
          * * * * * * *

                Good Manufacturing Practice Requirements

    (f)(1)(A) * * *
    (B) Before the Secretary may promulgate any regulation 
under subparagraph (A) he shall--
          (i) afford the advisory committee established under 
        paragraph (3) an opportunity to submit recommendations 
        to him with respect to the regulation proposed to be 
        promulgated, [and]
          (ii) afford opportunity for an oral hearing[.]; and
          (iii) ensure that such regulation conforms, to the 
        extent practicable, with internationally recognized 
        standards defining quality systems, or parts thereof, 
        for medical devices.
The Secretary shall provide the advisory committee a reasonable 
time to make its recommendation with respect to proposed 
regulations under subparagraph (A).
          * * * * * * *

             Exemption for Devices for Investigational Use

    (g)(1) It is the purpose of this subsection to encourage to 
the extent consistent with the protection of the public health 
and safety and with ethical standards, the discovery and 
development of useful devices intended for human use and to 
that end to maintain optimum freedom for scientific 
investigators in their pursuit of that purpose.
          * * * * * * *
    (6)(A) Not later than 120 days after the date of the 
enactment of the Medical Device Regulatory Modernization Act of 
1997, the Secretary shall by regulation establish, with respect 
to a device for which an exemption under this subsection is in 
effect, the following:
          (i) Procedures and conditions under which the 
        Secretary will, without requiring an additional 
        approval of an application for an exemption or the 
        approval of a supplement to such an application, 
        permit--
                  (I) developmental changes in the device that 
                do not constitute a significant change in 
                design or in basic principles of operation and 
                that are made in response to information 
                gathered during the course of an investigation; 
                and
                  (II) changes or modifications to clinical 
                protocols that do not affect the validity of 
                data or information resulting from the 
                completion of an approved protocol and do not 
                alter the relationship of likely patient risk 
                to benefit relied upon to approve a protocol.
          (ii) Procedures and conditions under which the 
        Secretary will, outside of an approved investigational 
        protocol (subject to compliance with regulations for 
        the protection of patients), permit uses of the device 
        in the diagnosis, monitoring, or treatment of diseases 
        or conditions that are life-threatening or could be 
        irreversibly debilitating, when--
                  (I) the treating physician determines that 
                the investigational use of the device likely 
                will provide a benefit; that the risk of not 
                using the device exceeds the probable risk of 
                using the device; and that there is no legally 
                marketed device alternative for the 
                satisfactory treatment or diagnosis of such 
                disease or condition;
                  (II) the Secretary determines that there is 
                sufficient evidence of safety and effectiveness 
                to support the investigational use of the 
                device in the case described in subclause (I);
                  (III) the Secretary determines that the 
                investigational use of the device will not 
                interfere with the initiation, conduct, or 
                completion of clinical investigations to 
                support marketing approval; and
                  (IV) the sponsor, or clinical investigator, 
                of the investigational use of the device 
                submits to the Secretary a clinical protocol 
                consistent with the provisions of paragraph (3) 
                and any regulations promulgated under such 
                paragraph describing the investigational use of 
                devices in a single patient or a small group of 
                patients.
  (B) Regulations under subparagraph (A)(i) shall provide that 
a change or modification described in such subparagraph is not 
permitted unless, not later than 5 days after making the change 
or modification, a notice of the change or modification is 
submitted to the Secretary.
  (C) Regulations under subparagraph (A)(ii) shall provide 
that, under appropriate conditions described by the Secretary 
in the regulations, the Secretary will authorize the shipment 
of investigational devices (as defined in the regulations) for 
the diagnosis, monitoring, or treatment of a serious disease or 
condition in emergency situations.
  (7)(A) In the case of a person intending to investigate the 
safety or effectiveness of a class III device or an implantable 
device, the Secretary shall ensure that the person has an 
opportunity, prior to submitting an application to the 
Secretary or to an institutional review board, to submit to the 
Secretary, for review, an investigational plan (including a 
clinical protocol). If the applicant requests a meeting with 
the Secretary regarding such review, the Secretary shall meet 
with the applicant not later than 30 days after receiving the 
request for the meeting.
  (B) Agreements regarding the parameters of an investigational 
plan (including clinical protocol) that are reached between the 
Secretary and a sponsor or applicant shall be reduced to 
writing and made part of the administrative record by the 
Secretary. Such agreements shall not be changed, except--
          (i) with the written agreement of the sponsor or 
        applicant; or
          (ii) pursuant to a decision, made in accordance with 
        subparagraph (C) by the director of the office in which 
        the device involved is reviewed, that a substantial 
        scientific issue essential to determining the safety or 
        effectiveness of the device involved has been 
        identified.
  (C) A decision under subparagraph (B)(ii) by the director 
shall be in writing, and may be made only after the Secretary 
has provided to the sponsor or applicant an opportunity for a 
meeting at which the director and the sponsor or applicant are 
present and at which the director documents the scientific 
issue involved.
          * * * * * * *

                     Humanitarian Device Exemption

  (m)(1) To the extent consistent with the protection of the 
public health and safety and with ethical standards, it is the 
purpose of this subsection to encourage the discovery and use 
of devices intended to benefit patients in the treatment and 
diagnosis of diseases or conditions that affect fewer than 
4,000 individuals in the United States.
  (2) The Secretary may grant a request for an exemption from 
the effectiveness requirements of sections 514 and 515 for a 
device for which the Secretary finds that--
          (A) * * *
          * * * * * * *
          (C) the device will not expose patients to an 
        unreasonable or significant risk of illness or injury 
        and the probable benefit to health from the use of the 
        device outweighs the risk of injury or illness from its 
        use, taking into account the probable risks and 
        benefits of currently available devic or alternative 
        forms of treatment.
The request shall be in the form of an application to the 
Secretary. Within 60 days of the date of the receipt of an 
application, the Secretary shall issue an order approving or 
denying the application, except that if the Secretary convenes 
a scientific advisory panel, the Secretary shall within 120 
days of the receipt of an application issue such order.
          * * * * * * *
  [(5) An exemption under paragraph (2) shall be for a term of 
18 months and may only be initially granted in the 5-year 
period beginning on the date regulations under paragraph (6) 
take effect. The Secretary may extend such an exemption for a 
period of 18 months if the Secretary is able to make the 
findings set forth in paragraph (2) and if the applicant 
supplies information demonstrating compliance with paragraph 
(3). An exemption may be extended more than once and may be 
extended after the expiration of such 5-year period.
  [(6) Within one year of the date of the enactment of this 
subsection, the Secretary shall issue regulations to implement 
this subsection.]
  (5) The Secretary may suspend or withdraw an exemption from 
the effectiveness requirements of sections 514 and 515 for a 
humanitarian device, after providing notice and an opportunity 
for an informal hearing, if any condition for granting such 
exemption for such device set forth in paragraphs (2) through 
(4) no longer is met.
  (6) The Secretary may require a person granted an exemption 
under paragraph (2) to demonstrate continued compliance with 
the requirements of this subsection if the Secretary believes 
such demonstration to be necessary to protect the public health 
or if the Secretary has reason to believe that the criteria for 
the exemption are no longer met.
          * * * * * * *

                        [postmarket surveillance

  [Sec. 522. (a) In General.--
          [(1) Required surveillance.--The Secretary shall 
        require a manufacturer to conduct postmarket 
        surveillance for any device of the manufacturer first 
        introduced or delivered for introduction into 
        interstate commerce after January 1, 1991, that--
                  [(A) is a permanent implant the failure of 
                which may cause serious, adverse health 
                consequences or death,
                  [(B) is intended for a use in supporting or 
                sustaining human life, or
                  [(C) potentially presents a serious risk to 
                human health.
          [(2) Discretionary surveillance.--The Secretary may 
        require a manufacturer to conduct postmarket 
        surveillance for a device of the manufacturer if the 
        Secretary determines that postmarket surveillance of 
        the device is necessary to protect the public health or 
        to provide safety or effectiveness data for the device.
  [(b) Surveillance Approval.--Each manufacturer required to 
conduct a surveillance of a device under subsection (a)(1) 
shall, within 30 days of the first introduction or delivery for 
introduction of such device into interstate commerce, submit, 
for the approval of the Secretary, a protocol for the required 
surveillance. Each manufacturer required to conduct a 
surveillance of a device under subsection (a)(2) shall, within 
30 days after receiving notice that the manufacturer is 
required to conduct such surveillance, submit, for the approval 
of the Secretary, a protocol for the required surveillance. The 
Secretary, within 60 days of the receipt of such protocol, 
shall determine if the principal investigator proposed to be 
used in the surveillance has sufficient qualifications and 
experience to conduct such surveillance and if such protocol 
will result in collection of useful data or other information 
necessary to protect the public health and to provide safety 
and effectiveness informationfor the device. The Secretary may 
not approve such a protocol until it has been reviewed by an 
appropriately qualified scientific and technical review committee 
established by the Secretary.]


                        postmarket surveillance


  Sec. 522. (a) In General.--The Secretary may by order require 
a manufacturer to conduct postmarket surveillance for any 
device of the manufacturer which is a class II or class III 
device the failure of which would be reasonably likely to have 
serious adverse health consequences or which is intended to 
be--
          (1) an implantable device, or
          (2) a life-sustaining or life-supporting device used 
        outside a device user facility.
  (b) Surveillance Approval.--Each manufacturer required to 
conduct a surveillance of a device shall, within 30 days of 
receiving an order from the Secretary prescribing that the 
manufacturer is required under this section to conduct such 
surveillance, submit, for the approval of the Secretary, a plan 
for the required surveillance. The Secretary, within 60 days of 
the receipt of such plan, shall determine if the person 
designated to conduct the surveillance has appropriate 
qualifications and experience to undertake such surveillance 
and if such plan will result in information necessary to 
determine the occurrence of unforeseen events. The Secretary, 
in consultation with the manufacturer, may by order require a 
prospective surveillance period of up to 36 months. Any 
determination by the Secretary that a longer period is 
necessary shall be made by mutual agreement between the 
Secretary and the manufacturer or, if no agreement can be 
reached, after the completion of a dispute resolution process 
as described in section 506A.
          * * * * * * *

                     CHAPTER VII--GENERAL AUTHORITY

            Subchapter A--General Administrative Provisions

          * * * * * * *


                           accredited persons


  Sec. 712. (a) In General.--The Secretary shall, not later 
than 1 year after the date of the enactment of the Medical 
Device Regulatory Modernization Act of 1997, accredit persons 
for the purpose of reviewing and initially classifying devices 
under section 513(f)(1) that are subject to a report under 
section 510(k). An accredited person may not be used to perform 
a review of a class III device, or a class II device which is 
intended to be permanently implantable or life sustaining or 
life supporting.
  (b) Accreditation.--
          (1) Programs.--The Secretary shall provide for such 
        accreditation through programs administered by the Food 
        and Drug Administration, other government agencies, or 
        by other qualified nongovernment organizations.
          (2) Accreditation.--
                  (A) General rule.--Not later than 180 days 
                after the date of the enactment of the Medical 
                Device Regulatory Modernization Act of 1997, 
                the Secretary shall establish and publish in 
                the Federal Register requirements to accredit 
                or deny accreditation to persons who request to 
                perform the duties specified in subsection (a). 
                The Secretary shall respond to a request for 
                accreditation within 60 days of the receipt of 
                the request. The accreditation of such person 
                shall specify the particular activities under 
                subsection (a) for which such person is 
                accredited.
                  (B) Withdrawal of accreditation.--The 
                Secretary may withdraw accreditation of any 
                person accredited under this paragraph, after 
                providing notice and an opportunity for an 
                informal hearing, when such person acts or 
                fails to act in a manner that is inconsistent 
                with the purposes of this section or poses a 
                threat to public health.
                  (C) Performance auditing.--To ensure that 
                persons accredited under this section will 
                continue to meet the standards of 
                accreditation, the Secretary shall--
                          (i) make onsite visits on a periodic 
                        basis to each accredited person to 
                        audit the performance of such person; 
                        and
                          (ii) take such additional measures as 
                        the Secretary determines to be 
                        appropriate.
                  (D) Annual report.--The Secretary shall 
                include in the annual report required under 
                section 903(e)(2) the names of all accredited 
                persons and the particular activities under 
                subsection (a) for which each such person is 
                accredited and the name of each accredited 
                person whose accreditation has been withdrawn 
                during the year.
          (3) Qualifications.--An accredited person shall, at a 
        minimum, meet the following requirements:
                  (A) Such person shall be an independent 
                organization which is not owned or controlled 
                by a manufacturer, supplier, or vendor of 
                devices and which has no organizational, 
                material, or financial affiliation with such a 
                manufacturer, supplier, or vendor.
                  (B) Such person shall be a legally 
                constituted entity permitted to conduct the 
                activities for which it seeks accreditation.
                  (C) Such person shall not engage in the 
                design, manufacture, promotion, or sale of 
                devices.
                  (D) Such person shall be operated in 
                accordance with generally accepted professional 
                and ethical business practices and shall agree 
                in writing that as a minimum it will--
                          (i) certify that reported information 
                        accurately reflects data reviewed;
                          (ii) limit work to that for which 
                        competence and capacity are available;
                          (iii) treat information received, 
                        records, reports, and recommendations 
                        as proprietary information;
                          (iv) promptly respond and attempt to 
                        resolve complaints regarding its 
                        activities for which it is accredited; 
                        and
                          (v) protect against the use, in 
                        carrying out subsection (a) with 
                        respect to a device, of any officer or 
                        employee of the person who has a 
                        financial conflict of interest 
                        regarding the device, and annually make 
                        available to the public disclosures of 
                        the extent to which the person, and the 
                        officers and employees of the person, 
                        have maintained compliance with 
                        requirements under this clause relating 
                        to financial conflicts of interest.
          (4) Selection of accredited persons.--The Secretary 
        shall provide each person who chooses to use an 
        accredited person to receive a section 510(k) report a 
        panel of at least 2 or more accredited persons from 
        which the regulated person may select 1 for a specific 
        regulatory function.
          * * * * * * *

                   CHAPTER VIII--IMPORTS AND EXPORTS

          * * * * * * *

                   office of international relations

  Sec. 803. (a) * * *
          * * * * * * *
  (c)(1) The Secretary shall participate in meetings with 
representatives of other countries to discuss methods and 
approaches to reduce the burden of regulation and harmonize 
regulatory requirements if the Secretary determines that such 
harmonization continues consumer protections consistent with 
the purposes of this Act. The Secretary shall, not later than 
180 days after the date of enactment of the Medical Device 
Regulatory Modernization Act of 1997, make public a plan that 
establishes a framework for achieving mutual recognition of 
good manufacturing practices inspections.
  (2) The Secretary shall report to the Committee on Commerce 
of the House of Representatives and the Committee on Labor and 
Human Resources of the Senate at least 60 days before executing 
any bilateral or multilateral agreement under paragraph (1).

                       CHAPTER IX--MISCELLANEOUS

          * * * * * * *

SEC. 903. FOOD AND DRUG ADMINISTRATION.

  (a) In General.--There is established in the Department of 
Health and Human Services the Food and Drug Administration 
(hereinafter in this section referred to as the 
``Administration'').
  (b) Mission.--The Food and Drug Administration shall promote 
the public health by promptly and efficiently reviewing 
clinical research and taking appropriate action on the 
marketing of regulated products in a timely manner, and with 
respect to such products shall protect the public health by 
ensuring that--
          (1) foods are safe, wholesome, sanitary, and properly 
        labeled;
          (2) human and veterinary drugs are safe and 
        effective;
          (3) there is reasonable assurance of safety and 
        effectiveness of devices intended for human use;
          (4) cosmetics are safe and properly labeled; and
          (5) public health and safety are protected from 
        electronic product radiation.
The Food and Drug Administration shall participate with other 
countries to reduce the burden of regulation, harmonize 
regulatory requirements, and achieve appropriate reciprocal 
arrangements.
  [(b)] (c) Commissioner.--
          (1) * * *
          * * * * * * *
  [(c)] (d) Technical and Scientific Review Groups.--The 
Secretary through the Commissioner of Food and Drugs may, 
without regard to the provisions of title 5, United States 
Code, governing appointments in the competitive service and 
without regard to the provisions of chapter 51 and subchapter 
III of chapter 53 of such title relating to classification and 
General Schedule pay rates, establish such technical and 
scientific review groups as are needed to carry out the 
functions of the Administration, including functions under the 
Federal Food, Drug, and Cosmetic Act, and appoint and pay the 
members of such groups, except that officers and employees of 
the United States shall not receive additional compensation for 
service as members of such groups.
  (e) Annual Report.--The Secretary shall, simultaneously with 
the submission each year of the budget for the Food and Drug 
Administration, submit to the Committee on Commerce of the 
House of Representatives and the Committee on Labor and Human 
Resources of the Senate an annual report which shall--
          (1) review the performance of the Food and Drug 
        Administration in meeting its mission and the 
        development of Food and Drug Administration policies to 
        implement such mission;
          (2) review the performance of the Food and Drug 
        Administration in meeting its own performance 
        standards, including its own outcome measurements, and 
        statutory deadlines for the approval of products or for 
        other purposes contained in this Act;
          (3) describe the staffing and resources of the Food 
        and Drug Administration;
          (4)(A) list each bilateral and multinational meeting 
        held by the Food and Drug Administration to address 
        methods and approaches to reduce the burden of 
        regulation, to harmonize regulation, and to seek 
        appropriate reciprocal arrangements, (B) describe the 
        goals, activities, and accomplishments of the Food and 
        Drug Administration in such meetings, and (C) list 
        issues that the Food and Drug Administration is 
        considering or has presented for each such meeting; and
          (5) summarize and explain each instance in the 
        previous fiscal year in which an application received 
        under section 515(c) was not reviewed in a manner to 
        achieve final action on such application within 180 
        days of its receipt.
          * * * * * * *

SEC. 906. INFORMATION SYSTEM.

  The Secretary shall, with respect to devices, establish and 
maintain an information system to track the status and progress 
of each application or submission submitted to the Secretary 
requesting agency action. The system shall permit access by the 
applicant under conditions specified by the Secretary.

SEC. 907. PRACTICE OF MEDICINE.

  Nothing in this Act shall be construed to limit or interfere 
with the authority of a health care practitioner to prescribe 
or administer any legally marketed device to a patient for any 
condition or disease within a legitimate health care 
practitioner-patient relationship. This section shall not limit 
any existing authority of the Secretary to establish and 
enforce restrictions on the sale or distribution, or in the 
labeling, of a device that are part of a determination of 
substantial equivalence, established as a condition of 
approval, or promulgated through regulations. Further, this 
section shall not change any existing prohibition on the 
promotion of unapproved uses of legally marketed devices.
          * * * * * * *

          ADDITIONAL VIEWS OF REPRESENTATIVE EDWARD J. MARKEY

    Medical devices have the power to heal. But they also have 
the power to do great harm and to kill. The FDA has been 
strengthened over the years, in part, because of public outrage 
over medical device tragedies which resulted in unnecessary 
death and suffering. I am troubled by some of the provisions in 
the device bill.
    First, I am disappointed with the provision that permits 
third-party review of devices. I question the need to allow 
private parties who may have a conflict-of-interest to perform 
regulatory reviews of new devices. Such a system invites 
abuses. Despite it's inherent flaws, this provision has managed 
to stay alive in this bill. Also disconcerting is the provision 
in the bill which would severely restrict the autonomy of the 
FDA to investigate those devices which are considered 
``substantially equivalent'' to ones previously approved, even 
when the FDA detects ``suspicious equivocation'' on the part of 
the applicant.
    Finally, the device bill contains two provisions that will 
change from mandatory to discretionary the requirement that 
device manufacturers do tracking and postmarket surveillance of 
their high-risk, life-sustaining or life-supporting devices. If 
these sections of the bill remain, we will actually have 
federal laws still on the books that require all automakers to 
track ignition switches in automobiles, while allowing device 
companies to fail to track the ignition switches in pacemakers. 
This would be laughable if it were not so close to becoming the 
law of the land.
    I offered an amendment at the full Commerce Committee mark-
up of H.R. 1710 that would strike Sections 14 and 15 of the 
bill, the sections titled ``Device Tracking and Postmarket 
Surveillance,'' and maintain current law. For reasons 
impossible to fathom, Sections 14 and 15 would repeal mandatory 
tracking and postmarket surveillance of high-risk medical 
devices, enacted as part of the Safe Medical Devices Act of 
1990, and make it optional. Without mandatory tracking of high 
risk devices like heart valves, pacemakers and implantable 
infusion pumps, it is impossible to find and warn patients 
whose lives are at risk from a faulty device.
    This basic safety tool is widely appreciated and routine 
for automobile safety. Recalls that save lives are effective 
only because car companies are required to keep track of what 
machinery was sold to which customer. It is absurd to think, 
that without my amendment, we will have in our country a higher 
consumer protection standard on car parts than on implantable, 
life-sustaining or supporting medical devices.
    Do we really want to place higher priority on the safety of 
car starters than on the safety of heart starters; a higher 
priority on tacking disk brakes than we do on tracking disc 
prostheses?
    Mandatory postmarket surveillance by the manufacturer, 
approved by the FDA, provides a systematic method to look for 
and catch problems with these very high risk devices when they 
are put on the market. This process amounts to an ``early-
warning detection system'' for threats to patients health and 
safety.
    The device industry may think the tracking and surveillance 
provisions in current law are too onerous. But the fact is that 
repealing them is too dangerous.
    If the engine in your Ford or Chevy poses a threat to your 
health and safety, the National Traffic and Motor Vehicle 
Safety Act empowers the government to require Ford or Chevy to 
track you down, have you bring your car in to the shop, and fix 
it. Shouldn't we require that same high standard for 
manufacturers of implantable, life-sustaining and life-
supporting medical devices? The engine, if you will, implanted 
in a human being?
    The Safe Medical Devices Act addressed this serious 
problem. The law was passed in direct response to the Bjork-
Shiley heart valve fiasco. When the FDA detected a pattern of 
device failure in Bjork-Shiley heart valve patients, where the 
valves were prone to fracture and failure, it ordered the 
manufacturer to notify the recipients of this potential 
problem, what symptoms to look for, and how to take action if 
the symptoms were evident. The company claimed that it had no 
record of how to find half of the recipients. Hundreds died in 
the U.S., and nearly 1,000 people died worldwide. Congress put 
the Safe Medical Device Act on the books to make sure that this 
disaster would never be repeated. It is not our job to repeal 
it.
    And to those who say that tracking doesn't work, I would 
like to share a story from this year to refute that claim. This 
past January doesn't work, I would like to share a story from 
this year to refute that claim. This past January, the FDA 
became aware that a ``runaway pacing malfunction'' in an 
implantable cardioverter defibrillator resulted in 3 patient 
deaths. Because of this tracking provision in current law, 97% 
of the 5,475 patients affected were notified to come in and 
have their devices reprogrammed.
    Some may want this mandate repealed because they consider 
it ``onerous.'' But the risk of this so-called reform is just 
too high.
    A large coalition of patient rights and consumer groups, 
including the Consumer Federation of American, Public Citizen, 
Victim Against Lethal Valves, and many others, strongly 
supported this amendment.
    I withdrew my amendment in full committee with after 
receiving assurances from the Chairman that these serious 
concerns would be addressed before the FDA bills came to the 
House floor. I believe that we must maintain current law and 
continue to make tracking and surveillance of implantable 
medical devices mandatory, and I hope we are able to reach a 
consensus on this matter before House floor action on this 
legislation.
    These are a few of the problems that must be ironed out if 
we are to maintain a strong and effective Food and Drug 
Administration. There is no better protector of American 
consumers and patients in the world, and I am hopeful that this 
bill can be amended to strengthen and protect the FDA.

                                                  Edward J. Markey.