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[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3201 Introduced in House (IH)]

104th CONGRESS
  2d Session
                                H. R. 3201

  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

                             March 29, 1996

 Mr. Barton of Texas (for himself, Mr. Greenwood, Mr. Richardson, Mr. 
  Bilirakis, Mr. Hall of Texas, Mr. Gordon, Mr. Burr, Ms. Eshoo, Mr. 
 Coburn, Mr. Brewster, Mr. Klug, Mr. Dooley of California, Mr. Ganske, 
Mr. McHale, Mr. Bilbray, Mr. Payne of Virginia, Mr. Oxley, Mr. Holden, 
 Mr. Fields of Texas, Mr. Paxon, Mr. Schaefer, Mr. Tauzin, Mr. Fox of 
    Pennsylvania, Mr. Upton, Mr. Campbell, Mr. McIntosh, Mr. Cox of 
  California, Mr. Dreier, Mr. Heineman, Mr. Funderburk, Mr. Weldon of 
   Florida, Mr. Hostettler, Mr. Shays, Mr. Hastert, Mr. Norwood, Mr. 
Burton of Indiana, Mr. Frazer, Mr. Stearns, Mr. Frisa, Mr. Ramstad, Mr. 
  Martini, and Ms. Dunn of Washington) 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 
Reform Act of 1996''.
    (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 a 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. Effectiveness determination.
Sec. 9. Premarket notification.
Sec. 10. Classification panels.
Sec. 11. Premarket approval.
Sec. 12. Accreditation of third parties.
Sec. 13. Reclassification of preamendment devices.
Sec. 14. Device tracking.
Sec. 15. Postmarket surveillance.
Sec. 16. Harmonization.
Sec. 17. Good manufacturing practice inspections.
Sec. 18. Use of scientific and medical information.
Sec. 19. Reports.
Sec. 20. G.M.P. and device reports.
Sec. 21. Civil penalties.
Sec. 22. Information system.
Sec. 23. Environmental impact review.
Sec. 24. Informal agency statements.
Sec. 25. Research and education; practice of medicine.
Sec. 26. 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 and safety and promptly and efficiently review and 
approve clinical research and marketing of 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 investigations under section 505(1), 
        product approvals under sections 505 and 506, and to perform 
        good manufacturing practice reviews under section 505(d)(3) and 
        520(f);
            ``(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 regulation, and to 
        seek appropriate reciprocal arrangements, list each such 
        meeting, and list pending issues specifying those that are not 
        consistent with or are contrary to the provisions of this Act; 
        and
            ``(5) compare the performance of the Food and Drug 
        Administration in approving innovative products with that of 
        the most successful agencies performing similar functions in 
        other countries and compare the resources used by such 
        agencies.''.

SEC. 3. DISPUTE RESOLUTION.

    Chapter V is amended by adding after section 522 the following:

                          ``dispute resolution

    ``Sec. 523. (a) At any time before the issuance of the notice under 
section 510(k) or an exemption for investigational use under section 
520(g) for a device, the applicant may, in writing, notify the 
Secretary that an impasse exists in the review of the application for a 
device under section 515 or the submission for such an exemption with 
respect to a specifically identified issue.
    ``(b) On receipt of the notification from the applicant, the 
Secretary shall refer the disputed issue--
            ``(1) to an existing (as of the date of the notification) 
        scientific advisory panel having expertise related to the 
        issue;
            ``(2) to a special Government employee, as defined in 
        section 202(a) of title 18, United States Code, or to a non-
        governmental person qualified to mediate or arbitrate the 
        substance of such impasse who is acceptable to the Secretary 
        and the applicant.
    ``(c) The applicant and representatives of the Secretary may 
consult with the panel, special Government employee, or non-
governmental person on the matter referred. The panel, special 
Governmental employee, or non-governmental person shall submit to the 
Secretary and the applicant a report containing recommendations 
(including a statement of reasons for the recommendations) regarding 
the matter not later than 60 days after the date of the referral, or 
not later than 90 days after the date of the referral if the panel, 
special Governmental employee, or non-governmental person considers the 
additional 30 days to be necessary. Not later than 30 days after the 
date of receiving the report, the Secretary shall, in writing, confirm 
or modify the recommendations received, providing reasons and reference 
to data before the panel, special Governmental employee, or non-
governmental person for any modification. If the Secretary fails to act 
on such a recommendation within 30 days of its receipt, the 
recommendation of the panel, special Government employee, or non-
governmental person shall be deemed to be the recommendation of the 
Secretary.
    ``(d) The Federal Advisory Committee Act shall not apply to any 
scientific advisory panel acting under this section.''.

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) permit the use of investigational devices, outside of 
        an investigational protocol, in the diagnosis or treatment of 
        diseases or conditions that are life-threatening or could be 
        irreversibly debilitating when the risk of not using the 
        investigational device exceeds the probable risk of using such 
        device as determined by the treating physician;
            ``(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 receipt of an investigational plan 
        under subparagraph (B), require the Secretary to respond in 
        writing to the submitter identifying each deficiency with the 
        plan and such other information that will facilitate the review 
        and approval of an application;
            ``(D) provide a submitter who disputes the Secretary's 
        response under subparagraph (C) a right to appear before a 
        classification panel constituted under section 513(b), at the 
        next scheduled panel meeting, and obtain the review by the 
        panel of the investigational plan and the Secretary's 
        evaluation of such plan;
            ``(E) 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; and
            ``(F) 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.''.

SEC. 5. SPECIAL REVIEW FOR CERTAIN DEVICES.

    Section 515(d) is amended by adding at the end the following:
    ``(4) In order to better treat or diagnose life-threatening or 
irreversibly debilitating diseases or conditions of man, 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 month after the date of 
the enactment of this paragraph, allowing 60 days for comment. The 
Secretary will publish a final regulation no later than 60 days after 
the last day of the comment period.''.

SEC. 6. EXPANDING HUMANITARIAN USE OF DEVICES.

    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 30 days of the 
        date of the receipt of an application, the Secretary shall 
issue an order approving or denying the application.''; and
            (2) by striking paragraphs (5) and (6).

SEC. 7. PERFORMANCE STANDARDS.

    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 recognizing applicable nationally or 
internationally recognized consensus standards in any determination as 
to whether there is 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 that 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.''.

SEC. 8. EFFECTIVENESS DETERMINATION.

    Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is amended--
            (1) in subparagraph (A), by inserting ``one or more'' after 
        ``on the basis of'' and by striking ``clinical investigations'' 
        and inserting ``a clinical investigation''; and
            (2) by adding at the end of subparagraph (A) the following: 
        ``A well-controlled clinical investigation--
            ``(i) shall not be considered appropriate unless the 
        Secretary determines, after consultation with a classification 
        panel established under subsection (b), that such investigation 
        is necessary to demonstrate 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; and
            ``(ii) shall only include methods of control that are 
        appropriate to the disease or condition for which a device is 
        intended as prescribed, recommended, or suggested in the 
        labeling of the device.
Any person may submit a well-controlled clinical investigation to the 
Secretary to demonstrate that a 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 and, without 
reliance on a classification panel, the Secretary may determine that 
such studies are appropriate for such purpose.''; and
            (3) by adding at the end the following:
    ``(C) For purposes of this paragraph, the determination of 
effectiveness shall not include any of the following:
            ``(i) The evaluation of clinical outcomes if the use of a 
        device provides a medical contribution to the diagnosis or 
        treatment of the persons for whom the device is intended unless 
        the labeling of the device represents that it provides a 
        therapeutic effect to the persons for whom the device is 
        intended.
            ``(ii) The evaluation of relative effectiveness unless the 
        performance of a device is compared to that of another device 
        through labeling or other representations by the person legally 
        responsible for the labeling of the device.
            ``(iii) The evaluation of cost effectiveness 
        representations unless the labeling specifically includes a 
        statement about the cost effectiveness.
            ``(iv) The evaluation of any indication for use not 
        included in the labeling of a device unless the person legally 
        responsible for the labeling of the device promotes such 
        indications for use.''.

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 under section 513 or 520 or any device 
classified into class 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)''; and
            (3) 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) 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 and recommendation with respect 
        to the classification of the device by a classification panel 
        established under subsection (b) 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 a classification panel 
        established under subsection (b) reviews the request with 
        respect to the classification of the device and, within 60 days 
        of the date of receiving the request, recommends to the 
        Secretary a classification for the device based on the 
        classification criteria set forth in subparagraphs (A) through 
        (C) of subsection (a)(1). Thereafter, the Secretary shall have 
        10 days to determine by order the final classification of the 
        device by applying such criteria. If the Secretary fails to 
        issue such an order within such 10 days, the recommendation of 
        the classification panel shall be deemed to be the order of 
        final classification of the device issued by the Secretary.''.
            (2) by adding at the end the following:
    ``(4)(A) Within 90 days of receiving a report required under 
section 510(k) for devices identified as being substantially equivalent 
to a class II device, a person accredited under section 712 to conduct 
reviews of such report shall determine the initial classification under 
paragraph (1)(A) of any such device which was not introduced or 
delivered for introduction into interstate commerce for commercial 
distribution before the date of the enactment of this subparagraph and 
shall submit such determination to the Secretary. The accredited person 
shall immediately, by registered mail, provide to the submitter of such 
report a copy of the recommendation to the Secretary for an order 
classifying the device. Such determination shall be considered to be an 
order of the Secretary initially classifying the device. If the 
accredited person determines that the device should be classified into 
class III, such person shall, immediately upon making such 
determination, refer the report to the Secretary.
    ``(B) Within 60 days of receiving a report required under section 
510(k) for a device identified as being substantially equivalent to a 
class III device, a person accredited under section 712 to conduct 
reviews of such report shall make a determination of the initial 
classification under paragraph (1)(A) of any such device which was not 
introduced or delivered for introduction into interstate commerce for 
commercial distribution before the date of the enactment of this 
subparagraph, and within such time period submit a recommendation to 
the Secretary and to the submitter of the report which contains such 
determination. The recommendation by such person of initial 
classification of a device shall be considered to be an order of the 
Secretary unless the Secretary, within 30 calendar days of receipt of 
the recommendation, finds that the device is not substantially 
equivalent to a predicate device and issues an order under this 
subsection initially classifying the device. Such order shall be based 
on the criteria in this subsection and subsection (i) and provide a 
detailed explanation and justification for the basis of the Secretary's 
disagreement, if any, with the accredited person's recommendation. If, 
within 90 days from the date of receipt of the report, the Secretary 
does not issue an order that differs from the recommendation of the 
accredited person, the Secretary shall promptly send by registered mail 
to the submitter of the report such recommendation as the Secretary's 
order of initial classification. If the Secretary does not provide the 
submitter such recommendation by registered mail as specified, the 
recommendation of classification provided to the submitter of the 
report shall become the Secretary's order of initial classification of 
the device. Such classification may only be changed pursuant to the 
procedures specified in paragraph (2) of this subsection.
    ``(5) 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).''.
    (c) Section 513(i).--Section 513(i) (21 U.S.C. 360c(i)) is 
amended--
            (1) in paragraph (1)(A)(ii)(I), by striking ``clinical 
        data'' and inserting ``either 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:
    ``(C) 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.
    ``(D) Any change or modification to a device, other than a major 
change (including any major modification) in the intended use, shall 
not require an additional submission under section 510(k) if such 
change or modification is supported by appropriate data or information 
and the change or modification can be shown to not adversely affect the 
safety or effectiveness of the device which was introduced in 
interstate commerce before May 28, 1976 or initially classified under 
subsection (f). All data or information relied upon to document that a 
change to (including any modification of) such a device does not 
require an additional report under section 510(k) shall be made 
available to the Secretary upon request and maintained for a period of 
time equal to at least the commercial life of the device.
    ``(E) 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 reports required under section 510(k).
    ``(F) For the purpose of determining substantial equivalence, the 
Secretary shall not consider any uses or indications for use of a 
device that are not specifically identified in a premarket market 
notification under section 510(k).
    ``(G) For the purpose of determining substantial equivalence the 
Secretary shall accept certification of compliance with nationally or 
internationally recognized consensus standards to resolve any 
substantial equivalence issue which such standards address. To the 
extent that a substantial equivalence issue is resolved by such 
standards, additional information shall not be required to further 
address such an issue.''.

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 least 6 times each calendar year to consider, 
among other things, the approval of applications submitted to the 
Secretary under section 515. Such meetings shall, to the extent 
possible, be scheduled at equal intervals throughout the year. Such 
meetings shall be held with the physical presence of panel members at 
least 3 times each calendar year. Other meetings of the panel may be 
held using electronic communication to convene the meeting.
    ``(6) Each member of a panel shall publically disclose all 
conflicts of interest that member may have with the work to be 
undertaken by the panel. No member of a panel may vote on any matter 
where the member could gain financially from the advice given to the 
Secretary. The Secretary may grant a waiver of any conflict of interest 
upon public disclosure of such conflict of interest if such waiver 
contributes to the ability of a panel to contribute to the public 
health, except that the Secretary may not grant a waiver for a member 
of a panel when the member's own scientific work is involved.
    ``(7) The Secretary shall provide education and training to each 
new panel member before such member participates in a panel's 
activities. Such education and training shall include a familiarization 
with certain requirements under this Act and any related regulation of 
the Secretary and the administrative process and procedures related to 
panel meetings.
    ``(8) The Secretary shall take whatever action is necessary to 
ensure that regular meetings are held by scientific advisory panels, at 
appropriate intervals and for a sufficient length of time, so that any 
matter to be reviewed by any such panel shall be presented to the panel 
not more than 60 days after the matter is ready for review by the 
panel. The meetings shall occur not less than 6 times each year unless 
there are compelling reasons for fewer meetings. Such meetings shall be 
held with the physical presence of panel members at least 3 times each 
calendar year. Other meetings of the panel may be held using electronic 
communication to convene the meeting.
    ``(9)(A) All persons, including employees of the Secretary, shall 
have the same rights and responsibilities regarding--
            ``(i) the submission of data and information to, and 
        contact and discussion with, 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) In a case in which a classification panel reviews a 
submission under section 510(k), all related data and information that 
are not available for public disclosure under section 552 of title 5, 
United States Code, shall be exchanged between the person who submitted 
such notice and the Food and Drug Administration at the time the data 
and information are submitted to such panel but shall not otherwise be 
publicly disclosed.
    ``(C) Any meetings of a classification panel shall provide adequate 
time for initial presentations and for response to any differing views 
and shall encourage free and open participation by all interested 
persons.
    ``(10) 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.
    ``(11) 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.

    (a) Section 515(c).--Section 515(c) (21 U.S.C. 360e(c)) is 
amended--
            (1) in the first sentence of paragraph (1), by inserting 
        immediately before the period the following: ``or may file such 
        application with a person authorized to review applications for 
        premarket approval under section 712''; and
            (2) by adding after paragraph (2) the following:
    ``(3)(A) The scope of review responsibilities of accredited persons 
authorized to conduct reviews of premarket approval applications under 
section 712 shall include--
            ``(i) the receipt and filing of applications for 
        substantive review;
            ``(ii) the review of applications to determine whether 
        there is a reasonable assurance that a device is safe and 
        effective for its labeled uses;
            ``(iii) the review of applications in accordance with the 
        schedule for review identified in subsection (d)(2) unless such 
        organization or person by contract with an applicant alters 
        such schedule or eliminates any item of review but not the 
        review by a classification panel under paragraph (2);
            ``(iv) the presentation, when appropriate, of such 
        applications to a classification panel constituted under 
        section 513(b); and
            ``(v) the evaluation of classification panel 
        recommendations and premarket approval applications and the 
        formulation of reports and recommendations to be submitted to 
        the Secretary no later than 30 days after receipt of a 
        classification panel's recommendation.
Recommendations to the Secretary shall specify whether an application 
should be approved or denied and shall state the basis for the 
recommendation.
    ``(B) The recommendation of an accredited person to approve or deny 
an application shall be considered to be an order of the Secretary 
unless the Secretary finds that there is a reasonable probability that 
the device is not safe or effective. In the event that the Secretary 
makes such a finding, the Secretary shall provide a detailed 
explanation of the basis of the finding.''.
    (b) Section 515(d).--Section 515(d) (21 U.S.C. 360e(d)) is amended 
by redesignating paragraphs (2) and (3) as paragraphs (5) and (6), 
respectively, by adding before the semicolon at the end of paragraph 
(5)(B) (as so redesignated) the following: ``and for purposes of this 
subparagraph, the determination of a reasonable assurance that a device 
is effective under the conditions of use prescribed, recommended, or 
suggested in proposed labeling shall not include uses or indications 
for use not identified in the application'', and by adding after 
paragraph (1) the following:
    ``(2) Each application received under subsection (c) shall be 
reviewed in the following manner to achieve final action on such 
applications within 180 days of its receipt:
            ``(A) The Secretary shall determine, within 30 days of the 
        receipt of an application submitted under subsection (c), 
        whether the application satisfies the content requirements of 
        subsection (c)(1) and applicable regulations.
            ``(B) The Secretary shall meet with an applicant on request 
        within 90 days of receipt of an application that has been 
        accepted for filing to discuss the review status of the 
        application. If the application does not appear in a form that 
        would necessitate an approval under this subsection, the 
        Secretary shall, in writing and prior to the meeting, present 
        to the applicant a description of any deficiencies with the 
        application and what information would be necessary to bring 
        the application into a form that would require an approval.
            ``(C) The Secretary shall refer an application to a 
        classification panel established under section 513 for review 
        and an approval recommendation, unless a panel is not required 
        under subsection (c)(2), within 30 days of the meeting referred 
        to in subparagraph (B). The application shall be reviewed at 
        the next scheduled panel meeting.
            ``(D) The Secretary shall, within 15 days before the date 
        of a panel review, provide to an applicant a statement of each 
        view or position the Secretary has communicated or intends to 
        communicate to a classification panel constituted under section 
        513(b) or any panel member regarding a premarket approval 
        application scheduled for a panel review. Additionally, at this 
        time the Secretary shall provide to the applicant all 
        information provided by the Secretary to such panel regarding 
        the review of a premarket application.
            ``(E) The Secretary shall meet not later than 10 days after 
        the panel review to present to an applicant a description of 
        all additional information necessary to require an approval of 
        an application under paragraph (1)(A) if the Secretary has 
        determined that the application appears to be in a form that 
        would receive approval within 180 days of receipt of such 
        application. The applicant may waive such meeting and instead 
        receive in writing from the Secretary such information within 
        30 days of the panel review.
            ``(F) The Secretary shall meet with the applicant not later 
        than 15 days after the panel review if the Secretary has 
        determined that the application is not in a form that would 
        require approval under paragraph (1)(A). Prior to the meeting, 
        the Secretary shall in writing present to the applicant each 
        basis for denying approval of the application and the 
        additional information necessary to bring the application into 
        a form that would require an approval.
            ``(G) When the Secretary reviews an application and a 
        classification panel review and recommendation is not required 
        under subsection (c)(2), the Secretary shall meet with the 
        applicant no later than 135 days after receipt of an 
        application which has been accepted for filing under subsection 
        (c)(1) and inform the applicant whether or not the application 
        is in a form that would require approval under paragraph 
        (1)(A). If the application is in such form, the Secretary 
        shall, at or prior to the meeting, present in writing a 
        description of all additional information necessary to require 
        an approval of an application under paragraph (1)(A). If the 
        application is not in such form, the Secretary shall, prior to 
        the meeting, present in writing to the applicant each basis for 
        denying approval of the application and the 
additional information necessary to bring the application into a form 
that would require approval.
            ``(H) When an application is reviewed by an accredited 
        person and a classification panel is not required under 
        subsection (c)(2) to review a premarket approval application, 
        the accredited person shall, no later than 120 days after 
        filing, or at such other designated time determined by the 
        applicant and the accredited person, provide the Secretary with 
        a report and recommendation.
            ``(I) The Secretary shall approve or deny an application 
        reviewed by an accredited person within 180 days of receipt of 
        an application which has been accepted for filing under 
        paragraph (1) unless the accredited person submits its report 
        and recommendation to the Secretary later than 150 days after 
        such receipt. If the report and recommendation of an accredited 
        person is submitted to the Secretary later than 150 days after 
        receipt of an application which has been accepted for filing 
        under paragraph (1), the Secretary shall have 30 days from the 
        date of receipt to approve or deny the application.
    ``(3)(A) The time for the Secretary's review of an application 
under this subsection shall not be enlarged by any amendment to the 
application and shall take no more than 180 days.
    ``(B) The Secretary shall ensure that each time frame under 
paragraph (2) is met. For each instance in which a review requirement 
under paragraph (2) is not met, a report to the Commissioner and the 
Secretary is required no later than 10 days after the date of the 
scheduled event set forth in paragraph (2) fully explaining the reason 
that the scheduled time frame was not met. Within 10 days after receipt 
of such report, the Commissioner shall provide an explanation to the 
applicant regarding the failure to comply with paragraph (2) and set 
the date for satisfying the scheduled review program obligation.
    ``(C) On January 1 of each calendar year, the Secretary shall 
submit to the committees of Congress with substantive oversight 
responsibility for the Food and Drug Administration 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.''.
    (c) Regulations.--The Secretary of Health and Human Services shall 
revise, through notice and comment procedures, the regulations 
appearing in part 814 of title 21 of the Code of Federal Regulations to 
conform to this section's amendment of section 515 of the Federal Food, 
Drug, and Cosmetic Act and to eliminate premarket approval of 
supplements which relate to manufacturing changes and other changes 
which do not actually affect device safety or effectiveness. The 
Secretary shall publish in the Federal Register such proposed 
regulation no later than 6 months after the date of the enactment of 
this Act, allowing 60 days for comment. The Secretary shall publish a 
final regulation no later than 60 days after the last day for the 
comment period.

SEC. 12. ACCREDITATION OF THIRD PARTIES.

    (a) Amendment.--Subchapter A of chapter VII is amended by adding at 
the end the following:

                          ``accredited persons

    ``(a) Sec. 712. In General.--The Secretary shall, within 180 days 
of the date of the enactment of this section, by regulation establish 
procedures for the accreditation of third parties for the purposes of--
            ``(1) reviewing applications under section 515, providing 
        written reviews to the Secretary for the Secretary's 
        consideration, and making recommendations on whether or not 
        such applications should be approved; and
            ``(2) conducting good manufacturing practice inspections to 
        determine the conformance of a facility with regulations 
        promulgated under section 520(f).
    ``(b) Accreditation.--
            ``(1) Programs.--The Secretary shall provide for such 
        accreditation through programs administered by government 
        agencies or by other qualified organizations.
            ``(2) Implementation.--The Secretary may designate one or 
        more qualified non-government organizations to implement such 
        programs. Such organizations shall implement such programs from 
        fees charged to applicants for accreditation.
            ``(3) Qualifications.--An accredited person shall meet the 
        following requirements:
                    ``(A) Such person shall be an independent 
                organization which is not owned or controlled by 
                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.''.
    (b) Conforming Amendment.--Section 301 (21 U.S.C. 321) is amended 
by redesignating the second paragraph (u) as paragraph (v) and by 
adding after that paragraph the following:
    ``(w) 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.''.

SEC. 13. RECLASSIFICATION OF PREAMENDMENT DEVICES.

    Section 515 (21 U.S.C. 360e) is amended by adding at the end the 
following:
    ``(j) The Secretary shall, within 18 months of the date of 
enactment of this subsection, publish in the Federal Register a 
proposed regulation reclassifying all devices identified in subsection 
(i)(2) into class II except a device for which the Secretary has 
already published a proposed regulation required under subsection 
(i)(2). The Secretary shall provide 60 days for comment on such 
proposed regulation required by this subsection and shall publish a 
final regulation in the Federal Register within 60 days after the last 
day for comment reclassifying into class II each such device not 
included in a proposed regulation required under subsection (i)(2) or 
maintaining, where appropriate, the original classification of such 
device.''.

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 life threatening or 
        have permanently debilitating effects; and
            ``(2) which is--
                    ``(A) a permanently 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 first introduced or delivered for introduction into 
interstate commerce after January 1, 1991, 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--
            ``(1) a permanently 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 notice 
from the Secretary that the manufacturer is required under this section 
to conduct such surveillance, submit, for the approval of the 
Secretary, a proposal for the required surveillance. The Secretary, 
within 60 days of the receipt of such proposal, shall determine if the 
person designated to conduct the surveillance has appropriate 
qualifications and experience to undertake such surveillance and if 
such proposal 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.''.

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 regularly and continuously 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. GOOD MANUFACTURING PRACTICE INSPECTIONS.

    (a) Section 704 (21 U.S.C. 374) is amended--
            (1) in subsection (a)(1), by inserting ``, or an accredited 
        person to conduct good manufacturing practice inspections under 
section 712'' after ``Secretary'';
            (2) in subsection (a)(3), by inserting ``, or an accredited 
        organization or individual under section 712,'' after 
        ``employee'';
            (3) in subsection (b), by inserting ``, or an accredited 
        person under section 712,'' after ``employee'';
            (4) in subsection (b), by inserting ``(1)'' after ``(b)'', 
        by redesignating clauses (1) and (2) as clauses (A) and (B), 
        respectively, and by adding at the end the following:
    ``(2) The Secretary shall provide, at least 10 days from the date 
of presentation of the report of conditions or practices identified in 
paragraph (1), for the person receiving such report to respond. The 
Secretary shall take no regulatory action against a person or article 
identified in such a report until completing a review of such response 
which is timely submitted to the Secretary, except the Secretary may 
take immediate action when the Secretary finds that there is a 
reasonable probability that a device intended for human use would cause 
serious, adverse health consequences or death or that any regulated 
article could present an unreasonable and substantial risk of injury or 
illness to the public health. The Secretary shall provide to the 
regulated person, within 30 days of receiving a response to the report 
identified in paragraph (1), a written detailed assessment of the 
response.
    ``(3) At the time an accredited person completes an inspection 
under the authority of this section and section 712, such person shall 
identify in writing to the person subject to the inspection each 
condition or practice observed during such inspection which suggests a 
deviation from requirements of this Act. However, such accredited 
person shall immediately submit to the Secretary the findings of the 
inspection when the device to which such findings relate is intended 
for human use and presents a reasonable probability that such device 
would cause serious, adverse health consequences or death or that such 
device could present an unreasonable and substantial risk of injury or 
illness to the public unless the person subject to the inspection--
            ``(A) immediately ceases distribution of the device;
            ``(B) immediately notifies health professionals and device 
        user facilities to instruct such professionals and facilities 
        to cease use of the device; and
            ``(C) immediately undertakes all corrections identified by 
        the accredited person.
When such compliance is complete, the accredited person shall provide 
the inspected person a certification of compliance which includes the 
dates of inspections, a statement that the inspected facility is in 
compliance with the requirements of section 520(f), the date the 
compliance was achieved at the facility, and the signature of the 
accredited person attesting to the finding that the inspected facility 
is in good manufacturing practices compliance as defined by such 
section. When an accredited person has certified compliance with good 
manufacturing practices requirements and provided the Secretary with a 
copy of the certification within 10 days of its being made, the 
Secretary may not perform a good manufacturing practices inspection of 
the person subject to an inspection for a period of 2 years after the 
date of the certification unless justified by good cause.''; and
            (5) in subsection (c), by striking ``or employee'' and 
        inserting ``, employee, or accredited person'';
            (6) in subsection (e), by striking ``or employee'' each 
        place it occurs and inserting ``, employee, or accredited 
        person''; and
            (7) by adding at the end the following:
    ``(f) Persons duly designated by the Secretary to conduct 
inspections under this section shall not request any information not 
permitted under subsections (a) and (e) unless such person states with 
specificity and in writing the identification of the information 
subject to the request, the reason for the request, and that the 
written request seeks to obtain information not required to be produced 
under this section. Such request shall not include information related 
to sales (other than distribution), personnel, or pricing data.''.

SEC. 18. USE OF SCIENTIFIC AND MEDICAL INFORMATION.

    Section 502(f) (21 U.S.C. 352(f)) is amended by adding at the end 
the following: ``The dissemination of medical texts, articles from 
peer-reviewed scientific publications, information from Federal 
Government agencies, and presentations at medical and scientific 
meetings shall not form a basis to require adequate directions for use 
under clause (1) or information for use (or the equivalent thereof) 
under any exemption to clause (1) and shall not form a basis to require 
the filing of a report required under section 510(k) or the filing of 
an application under section 505 or 515 unless such person, in addition 
to disseminating the above-referenced information, encourages the 
unapproved use of a legally marketed device through labeling, 
advertising, or other means of promotion. Mere knowledge that a legally 
available device is used by licensed practitioners for the treatment or 
diagnosis of diseases or conditions in individual patients shall not 
form a basis to require adequate directions for use under clause (1), 
or information for use (or the equivalent thereof) under any exemption 
to clause (1), and shall not form a basis to require either the filing 
of a notification required under section 510(k) or an application under 
section 515. The Secretary shall not consider the dissemination of 
medical texts, articles from peer review scientific publications, 
information from Federal Government agencies, presentations at medical 
and scientific meetings, and displays at trade shows relating to a 
device which is investigational within the meaning of section 520(g) to 
be activities prohibited under published regulations of the Secretary 
unless the sponsor of an investigation for the device, or an agent of 
such sponsor, in addition to the aforementioned activities encourages 
the use of a device.''.

SEC. 19. 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 paragraph (8)(B)(i) of subsection (a), by striking 
        ``manufacturer, importer, or distributor'' and inserting 
        ``manufacturer or importer''; and
            (5) 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, by striking paragraph (9).
    (b) Limitation on Malfunction Reporting.--Section 519(a)(1)(B) (21 
U.S.C. 360i(a)(1)(B)) is amended by inserting before the semicolon the 
following: ``, except that information that a device failed to perform 
as labeled or in an acceptable manner shall not constitute a 
malfunction within the meaning of this subparagraph when the available 
information clearly shows that the device failure was caused by 
improper servicing or maintenance to the device as determined 
exclusively by the device labeling which was provided to the user''.
    (c) 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 800 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 and shall amend the regulations of the 
Secretary to conform to the change in malfunction reporting in section 
519(a)(1)(B) of the Federal Food, Drug, and Cosmetic Act.
    (d) User Reports, Certifications, and Reports of Removals and 
Corrections.--Section 519 (21 U.S.C. 360i) is amended by repealing 
subsections (b), (d), and (f).

SEC. 20. G.M.P. AND DEVICE REPORTS.

    Section 303(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(g)(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. 21. CIVIL PENALTIES.

    Section 303 (21 U.S.C. 333) is amended--
            (1) in subsection (g)(2)(C), by adding at the end the 
        following: ``Additionally, the Secretary may direct a person 
        subject to a civil penalty under paragraph (1) to apply the 
        monetary amount of the penalty to the correction of the 
        violation that resulted in the penalty assessment in lieu of 
        paying such moneys into the United States Treasury. Any person 
        who undertakes correction of violations under this subparagraph 
        must submit an independent audit of the corrections to the 
        Secretary within a time specified in the civil penalty order. A 
        failure to submit such independent audit in a timely manner 
        shall be deemed to be a violation of this Act.''; and
            (2) in subsection (f)(2), by adding at the end ``The person 
        accused of a violation under this subsection shall be entitled 
        to reasonable discovery in accordance with the Federal Rules of 
        Civil Procedure.''.

SEC. 22. INFORMATION SYSTEM.

    Chapter IX, as amended by section 9, is amended by adding at the 
end the following:

``SEC. 907. 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. 23. ENVIRONMENTAL IMPACT REVIEW.

    Chapter VII, as amended by section 13, is amended by adding at the 
end the following:

              ``Subchapter E--Environmental Impact Review

``SEC. 745. ENVIRONMENTAL IMPACT REVIEW.

    ``No action by the Secretary pursuant to this Act shall require, 
with respect to an action to be taken by the Secretary, the preparation 
of an environmental impact statement under the National Environmental 
Policy Act of 1969 or an environmental assessment unless the Secretary 
demonstrates that--
            ``(1) because of extraordinary circumstances the action 
        will have a significant effect on the human environment; and
            ``(2) the consideration of such significant effect on the 
        human environment will directly affect the Secretary's decision 
        on the action.''

SEC. 24. INFORMAL AGENCY STATEMENTS.

    Section 701 (21 U.S.C. 371) is amended by adding at the end the 
following:
    ``(h)(1) The Secretary shall not rely upon informal agency 
statements, including guidance documents, policy statements, points to 
consider documents, or any other statements that have not been 
promulgated in accordance with the rulemaking requirements of chapter V 
of title 5, United States Code, to require any action be taken to 
satisfy a requirement of this Act.
    ``(2) The Secretary shall publish notice in the Federal Register of 
the availability to the public of each type of statement identified in 
paragraph (1). Additionally, the Secretary shall undertake to make 
available all such statements by electronic or other similar means.

SEC. 25. EDUCATION AND RESEARCH; PRACTICE OF MEDICINE.

    Chapter IX, as amended by section 23, is amended by adding at the 
end the following:

``SEC. 908. EDUCATION AND RESEARCH.

    ``(a) Education.--The Secretary shall conduct training and 
education programs for the employees of the Food and Drug 
Administration relating to the regulatory responsibilities and policies 
established by this Act, including programs for scientific training, 
administrative process and procedure, and integrity issues.
    ``(b) Research.--The Secretary, acting through the Food and Drug 
Administration, may conduct or contract for scientific research only if 
it is directly related to the implementation of this Act.

``SEC. 909. 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. 26. 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.''.
                                 <all>
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