[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1710 Introduced in House (IH)]







105th CONGRESS
  1st Session
                                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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 22, 1997

Mr. Barton of Texas (for himself, Ms. Eshoo, Mr. Bliley, Mr. Bilirakis, 
  Mr. Greenwood, Mr. Dan Schaefer of Colorado, Mr. Hall of Texas, Mr. 
 Hastert, Mr. Manton, Mr. Tauzin, Mr. Towns, Mr. Oxley, Ms. Furse, Mr. 
  Upton, Mr. Rush, Mr. Stearns, Mr. Paxon, Mr. Gillmor, Mr. Klug, Mr. 
  Crapo, Mr. Cox of California, Mr. Deal of Georgia, Mr. Largent, Mr. 
  Burr of North Carolina, Mr. Bilbray, Mr. Whitfield, Mr. Ganske, Mr. 
Norwood, Mr. White, Mr. Coburn, Mr. Lazio of New York, Mrs. Cubin, Mr. 
Rogan, Mr. Shimkus, Mr. Gordon, Mr. Ehrlich, Mr. Ramstad, Mr. Wynn, Ms. 
 McCarthy of Missouri, and Mr. Pallone) introduced the following bill; 
            which was referred to the Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
  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.

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

SECTION 1. SHORT TITLE; REFERENCE; 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. 301 et seq.).
    (c) Table of Contents.--The table of contents is as follows:

Sec. 1. Short title; reference; table of contents.
Sec. 2. FDA mission and annual report.
Sec. 3. Dispute resolution.
Sec. 4. Investigational device exemptions.
Sec. 5. Special review for certain devices.
Sec. 6. Expanding humanitarian use of devices.
Sec. 7. Performance 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. G.M.P. and device reports.
Sec. 19. Information system.
Sec. 20. Environmental impact review.
Sec. 21. Practice of medicine.
Sec. 22. Publication of notice of deviation.

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 protect the 
public health by ensuring that--
            ``(1) foods are safe, wholesome, and sanitary;
            ``(2) there is a reasonable assurance that human and 
        veterinary drugs and devices are safe and effective;
            ``(3) cosmetics are safe; and
            ``(4) public health and safety are protected from 
        electronic product radiation.
The Food and Drug Administration shall promptly and efficiently review 
clinical research and take appropriate action on the marketing of 
regulated products in a manner that does not unduly impede innovation 
or product availability. 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 and list those persons and organizations 
        accredited to conduct initial classification of devices under 
        section 513; and
            ``(4) describe the goals, activities, and accomplishments 
        of the Food and Drug Administration in bilateral and 
        multinational meetings that addressed methods and approaches to 
        reduce the burden of regulation, harmonize regulatory 
        requirements, and to seek appropriate reciprocal arrangements.
    ``(f) GAO Annual Report.--The Comptroller General of the United 
States shall each January submit to the Committee on Commerce of the 
House of Representatives and the Committee on Labor and Human Resources 
of the Senate a report which compares--
            ``(1) the performance of the Food and Drug Administration 
        in approving innovative drug, device, and food products with 
        that of agencies performing similar functions in countries 
        listed in section 802(b); and
            ``(2) the resources used by agencies in such countries to 
        approve such products.
In developing a methodology for the report, the Comptroller General 
shall consult with representatives of the Secretary, the regulated 
industry, academic experts in the field, and experts knowledgeable 
about information in such other countries so that the approach 
accurately presents the information in a fair and balanced manner.''.

SEC. 3. DISPUTE RESOLUTION.

    (a) Amendment.--Chapter V is amended by adding after section 522 
the following:

                          ``dispute resolution

    ``Sec. 523. In instances in which there is a scientific controversy 
between a regulated person and the Secretary regarding an obligation 
under this Act and no specific provision of this Act or regulations 
promulgated under this Act by the Secretary provide a right to review 
of the subject matter in dispute, the Secretary shall by regulation 
establish a procedure under which a regulated person may request such a 
review and such a review shall be provided in a timely manner.''.
    (b) Regulations.--The Secretary of Health and Human Services shall 
promulgate regulations implementing section 523 of the Federal Food, 
Drug, and Cosmetic Act within 180 days of the date of the enactment of 
this Act.

SEC. 4. INVESTIGATIONAL DEVICE EXEMPTIONS.

    Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at the end 
the following:
    ``(6) The Secretary shall, by regulation and within 120 days of the 
date of the enactment of this paragraph, update the procedures and 
conditions under which devices intended for human use may upon 
application be granted an exemption from certain requirements of this 
Act. Such regulation shall--
            ``(A) define the parameters for the use of investigational 
        devices for the benefit of individual patients, outside of an 
        ongoing investigational protocol (but subject to the patient 
        protections incorporated into part 812 or 813 of title 21, Code 
        of Federal Regulations), during the pendency of a premarket 
        approval application under section 515 and for uses intended to 
        demonstrate a reasonable assurance of a device's safety or 
        effectiveness in the diagnosis or treatment of diseases or 
        conditions that are life-threatening or could be irreversibly 
        debilitating, when (i) the treating physician determines that 
        the investigational device likely will provide a benefit, (ii) 
        the risk of not using the investigational device exceeds the 
        probable risk of using such device, and (iii) there is no 
        legally marketed device alternative for the satisfactory 
        treatment or diagnosis of such disease or condition;
            ``(B) ensure that prior to submitting an application to the 
        Secretary or to an institutional review board, any person 
        intending to investigate the safety or effectiveness of a class 
        III device or an implant device will have the opportunity to 
        submit an investigational plan, including a clinical protocol, 
        to the Secretary for review;
            ``(C) within 30 days of a request by an applicant for a 
        meeting with the Secretary, require, unless the applicant 
        waives this subparagraph, the Secretary to meet with the 
        applicant; and
            ``(D) permit developmental changes in devices in response 
        to information gathered during the course of an investigation 
        without requiring an additional approval of an application for 
        an investigational device exemption or the approval of a 
        supplement to such an application, if such changes do not 
        constitute a significant change in design or a significant 
        change in basic principles of operation;
            ``(E) without additional approval of an application for an 
        investigational device exemption, or the approval of a 
        supplement to such an application, permit 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; and
            ``(F) require a notice to the Secretary within 5 days of 
        implementing any change pursuant to subparagraph (D) or (E).
Any dispute arising from a change under subparagraph (D) or (E) shall 
be resolved under section 523(b).''.

SEC. 5. SPECIAL REVIEW FOR CERTAIN DEVICES.

    Section 515(d) (21 U.S.C. 360e(d)) is amended by adding at the end 
the following:
    ``(4) In order to better treat or diagnose life-threatening or 
irreversibly debilitating human diseases or conditions, the Secretary 
shall promulgate a regulation to create 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 public health.
Such regulation shall include, among other things, criteria identifying 
devices which merit preferential review, specifying procedures for 
implementing such reviews, and identifying substantive review criteria 
appropriate to making prompt and efficient review of such devices. The 
Secretary shall publish in the Federal Register a proposed regulation 
to create such review priority no later than 6 months after the date of 
the enactment of this paragraph, allowing 60 days for comment. The 
Secretary will publish a final regulation no later than 120 days after 
the last day of the comment period.''.

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 may have an additional 60 days in which to 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 striking paragraph (6).
    (b) Regulations.--Any 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 
promulgate regulations pertaining to humanitarian devices which are 
consistent with such amendments.

SEC. 7. PERFORMANCE STANDARDS.

    (a) Section 514.--Section 514 (21 U.S.C. 360d) is amended to read 
as follows:

                              ``standards

    ``Sec. 514. (a) The Secretary shall, through publication in the 
Federal Register, issue notices identifying and adopting applicable 
nationally or internationally recognized consensus 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. Any person may elect to 
utilize data other than those required by such standards to demonstrate 
a reasonable assurance of device safety or effectiveness or compliance 
with the requirements of this Act.
    ``(b) The Secretary shall accept certifications that devices 
conform with each type of standard referenced in subsection (a) and 
identified in each such certification to the extent such standard 
applies, except that the Secretary may, at any time, request the person 
who submitted the certification to submit the data and information 
which such person relied upon in making such certification.''.
    (b) Section 301.--Section 301 (21 U.S.C. 331) is amended by adding 
after paragraph (w) the following:
    ``(x) The making of a false or misleading certification under 
section 514(b) or the failure or refusal to provide the information 
required under section 514(c).''.

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'';
            (2) by adding at the end of subparagraph (A) the following: 
        ``In determining the type and amount of data necessary to find 
        a reasonable assurance of device effectiveness for an approval 
        under section 515, the Secretary shall consider the extent to 
        which reliance on postmarket controls may contribute to such 
        assurance and expedite effectiveness determinations without 
        increasing regulatory burdens on persons who submit 
        applications under section 515(c).'';
            (3) by adding at the end the following:
    ``(C)(i) The Secretary, upon the request of any person intending to 
submit an application under section 515, shall meet to determine the 
type of valid scientific evidence within the meaning of subparagraphs 
(A) and (B) that will be necessary to demonstrate the effectiveness of 
a device for the conditions of use proposed by such person to support 
an approval of an application. Within 30 days of such meeting, the 
Secretary shall identify in writing the type of valid scientific 
evidence that will provide a reasonable assurance that a device is 
effective under the conditions of use proposed by such person. Any 
clinical data, including one or more well-controlled investigations, 
specified by the Secretary for demonstrating a reasonable assurance of 
device effectiveness shall reflect the Secretary's determination that 
such data are necessary to establish device effectiveness and that no 
other less burdensome means of evaluating effectiveness are available 
that would have a reasonable likelihood of resulting in an approval.
    ``(ii) The Secretary's specification of the valid scientific 
evidence under clause (i) shall be binding upon the Secretary unless 
such determination by the Secretary would be contrary to the public 
health.''.
    (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) Any determinations of substantial equivalence by the 
Secretary shall be based upon the labeling submitted in a report under 
section 510(k) or labeling agreed to between the Secretary and persons 
who submit such report.
    ``(F) Representations in promotional materials shall not require a 
report under section 510(k) unless such materials support or promote 
new intended uses of a legally marketed device.''.
    (c) Section 515(d).--Section 515(d) (21 U.S.C. 360e(d)) is 
amended--
            (1) by adding at the end of paragraph (1)(A) the following:
``The Secretary's determination to approve or deny an application shall 
be based on the conditions of use proposed in labeling. If, based on a 
fair evaluation of all material facts, the proposed labeling is neither 
false or misleading in any particular, the Secretary shall not consider 
matters outside of such labeling in disposing of the application.''; 
and
            (2) by adding after paragraph (4), as added by section 5, 
        the following:
    ``(5)(A) Supplemental applications shall be required for any change 
to a device subject to an approved application under this subsection 
which affects safety or effectiveness and if a change was made under 
the requirements of section 520(f), the holder of the approved 
application shall notify the Secretary of such change.
    ``(B) When 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 when 
nonclinical data demonstrate that a design modification achieves the 
intended additional capacity, function, or performance without reducing 
the safety or effectiveness of the device and, when appropriate, 
clinical data in the approved application and supplements thereto and 
clinical data specifically evaluating the design modification provide 
reasonable assurance of device effectiveness.
    ``(6) Representations in promotional materials for devices subject 
to approved applications under paragraph (1) shall not be subject to 
premarket approval under this section, unless such representations 
establish new conditions of use. Any such representations must be 
supported by appropriate substantiation materials in the application 
holder's possession at the time such representations are made.''.

SEC. 9. PREMARKET NOTIFICATION.

    (a) Section 510.--Section 510 (21 U.S.C. 360) is amended--
            (1) in subsection (k), by inserting after ``a device 
        intended for human use'' the following: ``(other than any 
        device classified into class I or II under section 513 or 520 
        if such class II device has been exempted from the requirements 
        of this subsection under subsection (l))'';
            (2) in subsection (k), by striking ``report to the 
        Secretary'' and inserting ``have the option of reporting to the 
        Secretary or any person who is not an employee of the United 
        States and who is accredited under section 712(a)'';
            (3) by adding after and below paragraph (2) of subsection 
        (k) the following:
``The accredited person shall review a report made to the person and 
submit, not later than 60 days after receiving the report, to the 
Secretary the person's recommendation for action to be taken by the 
Secretary on the report.''; and
            (4) by adding the following after subsection (k):
    ``(l) Within 30 days after the date of the enactment of this 
subsection, 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). If the Secretary fails to respond to a petition within 
120 days of receiving it, the petition shall be deemed to be 
granted.''.
    (b) Reports Under Section 510(k).--Class I devices which are 
intended to be life supporting or life sustaining, intended for a use 
which is of substantial importance in preventing impairment of human 
health, or present a potential unreasonable risk of illness or injury 
shall not be excluded from the requirements of reports under section 
510(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)).
    (c) 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 individual 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. After the request, a device 
        classified into class III under this paragraph 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).''.
    (d) Section 513(i).--Section 513(i) (21 U.S.C. 360c(i)), as amended 
by section 8(b), is amended--
            (1) in paragraph (1)(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 paragraph (1)(A)(ii)(II), by striking ``efficacy'' 
        and inserting ``effectiveness''; and
            (3) by adding at the end of paragraph (1) the following:
    ``(G) 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 found 
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 unsafe or ineffective.
    ``(H) For the purpose of determining the intended use of a 
predicate device under subparagraph (A), each use reasonably included 
within a general use for the predicate device shall be deemed a legally 
marketed use of the predicate device and shall be available for use in 
premarket notifications required under section 510(k).''.
    (e) Sunset.--The amendment made by subsections (a)(2) and (d)(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) the submission of written information to a 
        classification panel;
            ``(ii) the participation of the persons at meetings of the 
        panel; and
            ``(iii) 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).
    ``(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) Within 30 days after the date a classification panel makes 
its conclusions and recommendations on any matter under review by the 
panel, the Food and Drug Administration official responsible for the 
matter shall review the conclusions and recommendations of the panel, 
shall make a final decision on the matter, 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. Such a panel shall make an annual 
report of its activities to the Secretary.''.

SEC. 11. PREMARKET APPROVAL.

    Section 515(d) (21 U.S.C. 360e(d)), as amended by section 8(c)(2), 
is amended by redesignating paragraphs (2), (3), (4), (5), and (6) as 
paragraphs (5), (6), (7), (8), and (9), respectively, and by adding 
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. The Secretary shall meet with an applicant, at 
the request of the applicant, under such an application within 90 days 
of the date of the application's submission.
    ``(3) On January 1 of each calendar year, the Secretary shall 
submit to the Committee on Commerce of the House of Representatives and 
the Committee on Labor and Human Resources of the Senate a report 
summarizing each instance in the previous fiscal year in which the 
requirements of paragraph (2) were not met. This report shall include 
reasons for the failures to meet the requirements of paragraph (2) and 
proposals to ensure that such requirements will be met.''.

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, within 1 year of 
the date of the enactment of this section, 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.--Within 180 days of the date of 
                the enactment of this section, 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; and
                            ``(iv) promptly respond and attempt to 
                        resolve complaints regarding its activities for 
                        which it is accredited.
            ``(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--
            ``(A) the submission of a report or recommendation by a 
        person accredited under section 712 that is false or misleading 
        in any material respect;
            ``(B) 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
            ``(C) 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 Secretary of Health and Human Services 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) Within 6 months of 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 section 515(B), and for which the Secretary has 
determined that premarket approval is unnecessary to protect the public 
health. Each such type of device listed in the Federal Register 
publication shall be regulated as a class III device subject to the 
general controls under this Act and appropriate special controls.''.

SEC. 14. DEVICE TRACKING.

    Subsection (e) of section 519 (21 U.S.C. 360i) is amended to read 
as follows:
    ``(e) Device Tracking.--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; and
            ``(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 and 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. Any order requiring a prospective 
postmarket surveillance shall not require a surveillance period greater 
than 18 months unless the Secretary for public health concerns extends 
the period for an additional 18 months.''.

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 the international standards organization 
        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 other 
countries to discuss methods and approaches to reduce the burden of 
regulation, harmonize regulatory requirements, and seek appropriate 
reciprocal arrangements. The Secretary shall, within 180 days of the 
date of enactment of this subsection, make public a plan that 
establishes a framework for achieving mutual recognition of good 
manufacturing practices.
    ``(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) Exclusion of Reports by Distributors.--Section 519 (21 U.S.C. 
360i) is amended--
            (1) in subsection (a), by striking ``manufacturer, 
        importer, or distributor'' and inserting ``manufacturer or 
        importer'';
            (2) in paragraph (4) of subsection (a), by striking 
        ``manufacturer, importer, or distributor'' and inserting 
        ``manufacturer or importer'';
            (3) in paragraph (8) of subsection (a), by striking 
        ``manufacturer, importer, or distributor'' each place it occurs 
        and inserting ``manufacturer or importer'';
            (4) in subsection (a), by inserting ``and'' at the end of 
        paragraph (7), by striking ``; and'' at the end of paragraph 
        (8) and inserting a period, and by striking paragraph (9).
    (b) Regulations.--Within 120 days after the date of enactment of 
this section, the Secretary of Health and Human Services shall delete 
the regulations of the Secretary appearing in part 804 of title 21 of 
the Code of Federal Regulations, requiring distributors, other than 
importers, to make reports of deaths, serious injuries or illness, and 
malfunctions related to devices.
    (c) Certifications, and Reports of Removals and Corrections.--
Section 519 (21 U.S.C. 360i) is amended by striking subsections (d) and 
(f).
    (d) Designated Device User Facilities.--Section 519(b) (21 U.S.C. 
360i(b)) is amended--
            (1) by redesignating paragraphs (2) through (5) as 
        paragraphs (3) through (6), respectively;
            (2) by striking ``(b)(1)(A) Whenever a device user facility 
        receives'' and inserting the following:
``(b)(1) One year after the date of the enactment of the Medical Device 
Regulatory Modernization Act of 1997, regulations included in title 21, 
Code of Federal Regulations, pertaining to user reporting shall be 
deemed to be rescinded by the Secretary. On and after such date, there 
shall be no obligations for any device user facility to comply with 
this subsection until the Secretary promulgates regulations which limit 
user reporting to a subset of hospitals and nursing homes to create a 
representative profile of user reports for device deaths and serious 
illnesses or serious injuries.
    ``(2)(A) Whenever a designated device user facility receives'';
            (3) in paragraph (2) (as designated by paragraph (2) of 
        this subsection)--
                    (A) in subparagraph (B), in the matter preceding 
                clause (i), by inserting ``designated'' before ``device 
                user facility'';
                    (B) in subparagraph (C)--
                            (i) in the first sentence--
                                    (I) by inserting ``designated'' 
                                before ``device user facility''; and
                                    (II) 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
                    (C) in subparagraph (D), by inserting 
                ``designated'' before ``device user facility'';
            (4) in each of paragraphs (3) through (5) (as redesignated 
        by paragraph (1) of this subsection), by striking ``paragraph 
        (1)'' each place such term appears and inserting ``paragraph 
        (2)''; and
            (5) in paragraph (6) (as redesignated by paragraph (1) of 
        this subsection)--
                    (A) by redesignating subparagraph (B) as 
                subparagraph (C); and
                    (B) by inserting after subparagraph (A) the 
                following:
            ``(B) The term `designated device user facility' means a 
        hospital or a nursing home that is designated as a member of 
        the subset established by the Secretary for purposes of 
        paragraph (1).''.

SEC. 18. G.M.P. AND DEVICE REPORTS.

    Section 303(c) (21 U.S.C 333(c)) is amended by inserting before the 
period at the end the following: ``; or (6) for having violated 
subsection (a), (b), (c), or (k) of section 301 by failure to comply 
with either section 502(t)(2) or 501(h), or for having violated section 
301(q)(1)(B) by failing to furnish material or information required 
under section 519(a), if such person acted in good faith, had no reason 
to believe that the person's acts violated the law, and had no prior 
notice from the Secretary that the acts constituted violations of the 
Act''.

SEC. 19. INFORMATION SYSTEM.

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

``SEC. 906. INFORMATION SYSTEM.

    ``The Secretary shall establish and maintain an information system 
to track the status and progress of each application or submission 
(including a petition, notification, or other similar form of request) 
submitted to the Food and Drug Administration requesting agency action. 
The system shall permit access by the applicant.''.

SEC. 20. ENVIRONMENTAL IMPACT REVIEW.

    Chapter VII is amended by adding at the end the following:

              ``Subchapter D--Environmental Impact Review

``SEC. 741. ENVIRONMENTAL IMPACT REVIEW.

    ``No action by the Secretary proposed to be taken pursuant to this 
Act shall require the preparation of an environmental assessment or 
environmental impact statement under the National Environmental Policy 
Act of 1969 unless the Secretary finds that because of extraordinary 
circumstances the proposed action may have a significant effect, either 
directly or cumulatively, on the human environment.''.

SEC. 21. PRACTICE OF MEDICINE.

    Chapter IX, as amended by section 19, 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, licensed by law to 
administer drugs and devices, to prescribe or administer any legally 
marketed drug or device to a patient for any condition or disease 
within a legitimate health care practitioner-patient relationship.''.

SEC. 22. PUBLICATION OF NOTICE OF DEVIATION.

    Section 705 (21 U.S.C 375) is amended by adding at the end the 
following:
    ``(c) The Secretary may make public or communicate to any person 
outside the Food and Drug Administration any information regarding a 
notice which informs a regulated person of a purported deviation from a 
requirement of this Act only after the Secretary has completed the 
investigation of such deviation, except as provided in subsection 
(b).''.
                                 <all>