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[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2290 Introduced in House (IH)]

  1st Session
                                H. R. 2290

 To amend the medical device provisions of the Federal Food, Drug, and 
                             Cosmetic Act.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                           September 8, 1995

   Mr. Fox of Pennsylvania introduced the following bill; which was 
                 referred to the Committee on Commerce

_______________________________________________________________________

                                 A BILL

 
 To amend the medical device provisions of the Federal Food, Drug, and 
                             Cosmetic Act.
    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE AND REFERENCE.

    (a) Short Title.--This Act may be cited as the ``Life Extending and 
Life Saving Device Act of 1995''.
    (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. 
201 et seq.).

SEC. 2. DEFINITIONS.

    Section 201 (21 U.S.C. 321) is amended--
            (1) in paragraph (h), by striking ``reagent'' and inserting 
        ``in vitro diagnostic test system, special purpose reagent,'', 
        and
            (2) by adding at the end the following:
    ``(gg) The term `special purpose reagent' means any monoclonal or 
polyclonal antibody, antigen, genetic probe, or other similar or 
related article that is a component of an in vitro diagnostic test 
system.
    ``(hh) The term `in vitro diagnostic test system' means a system 
intended for use in the diagnosis of disease or other conditions, 
including a determination of the state of health, in order to cure, 
mitigate, treat, or prevent disease or its sequelae.''.

SEC. 3. MISSION OF THE FOOD AND DRUG ADMINISTRATION.

    Section 903 (21 U.S.C. 393) is amended by adding at the end the 
following:
    ``(d) The mission of the Food and Drug Administration (with respect 
to drugs, biological products, and devices) is to promote and protect 
the health of the American people. This mission should be achieved by--
            ``(1) facilitating the timely availability of safe and 
        effective products that benefit the American public,
            ``(2) encouraging the efficient development of new products 
        in the United States,
            ``(3) taking prompt and appropriate action where 
        postmarketing surveillance demonstrated that products present a 
        health risk to the American public,
            ``(4) ensuring that human drugs, biological products, and 
        devices are tested and manufactured consistent with the goal of 
        harmonization of international standards,
            ``(5) facilitating the flow of information to educate 
        health professionals and the American public, and
            ``(6) enforcing the applicable statutes and regulations in 
        a timely, fair, and decisive manner.''.

SEC. 4. HARMONIZATION.

    Section 803 (21 U.S.C. 383) is amended by adding at the end the 
following:
    ``(c)(1) The Secretary shall take such action as may be appropriate 
to harmonize the requirements of this Act for good manufacturing 
practice regulations with requirements of similar laws in foreign 
countries through the International Conference on Harmonization by 
December 1996.
    ``(2) The Secretary shall regularly participate in meetings with 
other foreign governments to discuss methods and approaches to 
harmonize international regulatory requirements. The office shall 
forward any proposed agreements resulting from such meetings to the 
appropriate officials in each participating country for consideration 
in the formulation of agreements to harmonize international regulatory 
requirements. The office shall have the responsibility of ensuring that 
the process of harmonizing international regulatory requirements for 
devices and drugs is continuous.
    ``(3) The Commissioner shall initially report to committees of the 
United States Congress with oversight responsibilities for the United 
States Food and Drug Administration regarding the efforts and 
accomplishments of the office no later than 18 months after the date of 
enactment of this paragraph. Thereafter, the Commissioner shall report 
to such committees biennially.''.

SEC. 5. PREMARKET NOTIFICATION.

    (a) Section 510 (21 U.S.C. 360) is amended--
            (1) in subsection (k), by inserting ``excluding 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 paragraph (1),'' after 
``a device intended for human use'',
            (2) in subsection (k), by striking ``report'' and inserting 
        ``have the option of reporting'',
            (3) in subsection (k), by striking ``or any person who is 
        not an employee of the United States, and who is accredited by 
        the Secretary or the Secretary's designee to receive and review 
        notifications required under this subsection and to make 
        recommendations under subsection 513(f)(1) about such 
        notifications'' after ``report to the Secretary'', and
            (4) by inserting after subsection (k) the following:
    ``(l) Within 3 months after the date of the enactment of this 
subsection, the Secretary shall publish a notice in the Federal 
Register soliciting from the public the identification of class II 
devices that should not be subject to the notification requirements of 
subsection (k) because such notification is unnecessary to ensure 
public health. The notice shall provide no more than 30 days for 
submission of information to the Secretary, and the Secretary shall by 
regulation exempt specified class II devices from notification under 
subsection (k). The proposal for such a regulation shall permit 30 days 
for comment. The Secretary shall publish a final regulation in the 
Federal Register no later than 45 days after the end of the comment 
period. If the Secretary fails to promulgate a final regulation 45 days 
after the end of the comment period, each class II device proposed for 
exemption from subsection (k) shall be deemed to be exempt from that 
subsection.
    ``(m) The Secretary may not withhold a determination of the initial 
classification of a device under section 513(f)(1) for any reason, 
including that the facility in which a device may be manufactured is 
not in compliance with good manufacturing practice requirements set 
forth in regulations promulgated under the authority of section 
520(f).''.
    (b) Notice.--Section 513(f) (21 U.S.C. 360c(f)) is amended by 
redesignating paragraphs (2) and (3) as paragraphs (3) and (4), 
respectively, and by inserting after paragraph (1) the following:
    ``(2)(A) If the Secretary fails to make a determination under 
paragraph (1)(A) within 90 days of receipt of a notification required 
by subsection (k), the Secretary shall send a letter by registered mail 
to the submitter of such notification stating that additional time is 
necessary to determine the initial classification of the device. 
Additionally, such letter shall state each reason necessitating the 
need for additional time and provide the submitter a date for 
completion.
    ``(B) Within 90 days of receiving a notification required under 
subsection (k) for devices identified as being substantially equivalent 
to a class II device, a person accredited to conduct reviews of such 
notifications shall make a determination of 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 enactment of this section. Such 
determination of initial classification shall be final. The accredited 
person shall immediately, by registered mail, provide to the submitter 
of such notification an order classifying the device. If the accredited 
person determines that the device should be classified into class III, 
such person shall refer the premarket notification submission to the 
Secretary. The Secretary shall have 30 days to review the submission 
and issue an order initially classifying the device. If the Secretary 
fails to make a classification decision within 30 days, the Secretary 
shall send a letter to the submitter of the notification which conforms 
to the requirements of subparagraph (A).
    ``(C) Within 60 days of receiving a notification required under 
subsection (k) for a device identified as being substantially 
equivalent to a class III device, a person accredited to conduct 
reviews of such notification 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 enactment of this section, 
and within such time period submit a recommendation to the Secretary 
and to the submitter of the premarket notification which contains such 
determination. The recommendation by such person of initial 
classification of a device shall be binding upon the Secretary, unless 
the Secretary within 30 calendar days of receipt of the recommendation 
finds that the recommendation is clearly erroneous, issues an order 
under this subsection initially classifying the device and provides, as 
part of the order, a detailed explanation of the basis for the finding 
that the classification recommendation of the accredited person is 
clearly erroneous. If within 90 days from the date of receipt of the 
notification 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 notification 
such recommendation as the Secretary's order of initial classification. 
If the Secretary does not provide the submitter such notification by 
registered mail as specified herein, the recommendation of 
classification provided to the submitter of the premarket notification 
shall become the Secretary's order of initial classification of the 
device. Such classification may only be charged pursuant to the 
procedures specified in paragraph (3) of this subsection.
    ``(D) Any change or modification to a device initially classified 
under this subsection, other than a major change (including any major 
modification) in the intended use, shall not require an additional 
submission under subsection (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 initially classified under this 
subsection. All data or information relied upon to document that a 
change to (including any modification of) such device does not require 
an additional notification under subsection (k) shall be made a part of 
the good manufacturing practice document file required by regulations 
promulgated under section 520(f) and shall be maintained for a period 
of time equal to the commercial life of the device, at a minimum.''.
    (c) Section 513(i)(1) (21 U.S.C. 360c(i)(1)) is amended by adding 
after subparagraph (B) the following:
    ``(C) 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 in premarket notifications required under subsection 
(k).
    ``(D) For the purpose of determining substantial equivalence, the 
Secretary shall not consider any uses or indications of a device that 
are not specifically identified in a premarket market notification 
submission under subsection (k).''.

SEC. 6. THE RISK/BENEFIT DETERMINATION.

    Section 513(a)(2)(A) is amended by striking the comma following the 
word ``intended'' and adding to the end of the paragraph the following: 
``by the person legally responsible for labeling the device,''.

SEC. 7. EFFECTIVENESS DETERMINATION.

    (a) Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A)) is amended by 
adding at the end the following: ``Well-controlled clinical 
investigations shall not be appropriate, unless the Secretary 
determines, after consultation with an advisory committee constituted 
under subsection (b) that such investigations are 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. Any person may 
submit well-controlled clinical investigations 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 
as suggested in the labeling of the device, and, without reliance on an 
advisory committee, the Secretary may determine that such studies are 
appropriate for such purpose.''.
    (b) Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is amended by adding 
at the end the following:
    ``(C) 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 device is represented in the labeling of the device 
        to provide 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.
            ``(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. 8. PREMARKET APPROVAL.

    (a) Section 515(c)(1) (21 U.S.C. 360e(c)(1)) is amended by 
inserting ``, or may file such application with a person or 
organization authorized to review applications for premarket approval'' 
after ``class III device'' and by redesignating paragraph (2) as 
paragraph (4) and by adding after paragraph (1) the following:
    ``(2)(A) Persons or organizations authorized to receive and review 
applications for approval of class III devices shall review such 
applications in accordance with the schedule of events identified in 
subsection (d)(2), unless such organization or person by contract with 
an applicant alters the schedule of events or eliminates any such event 
other than the requirements to file an application before undertaking a 
substantive review, refer an application under subparagraph (C) to an 
advisory committee constituted under the authority of section 513(b), 
and complete the review of an application in a timely manner.
    ``(B) The review standard for a premarket approval application 
applicable to such persons or organizations shall be identical in all 
respects to the standard of review the Secretary is required to follow 
under this section.
    ``(C) The scope of review responsibility of such persons or 
organizations authorized to conduct reviews of premarket approval 
applications shall include--
            ``(i) the 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 presentation, when appropriate, of such 
        applications to an advisory committee constituted under section 
        513(b), and
            ``(iv) the evaluation of advisory committee 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 an advisory committee's 
        recommendation.
Recommendations to the Secretary shall specify whether an application 
should be approved or denied and shall state the basis for the 
recommendation.
    ``(D) If an advisory committee is not required to review a 
premarket approval application, such person or organization 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 in accordance with the 
requirements of subparagraph (C).
    ``(E) 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 subsection (c), 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 subsection (c), the Secretary shall have 30 
days from the date of receipt to approve or deny the application.
    ``(F) The recommendation of an accredited person to approve or deny 
an application shall be binding upon the Secretary, unless the 
Secretary finds that such recommendation is clearly erroneous. In the 
event that the Secretary makes such a finding, the Secretary shall 
provide a detailed explanation of the basis therefor.
    ``(G) The Secretary shall approve or deny applications for 
premarket approval of class III devices pursuant to the requirements of 
subsection (d).
    ``(3) The Secretary may use experts qualified by training and 
experience in addition to employees of the United States Government to 
review applications. Reviews by such experts may relate to portions of 
an application or entire applications. Each such review shall be in 
writing and submitted to the Secretary for consideration of whether to 
approve a device for commercial distribution.''.
    (b) Section 515(c) (21 U.S.C. 360e(c)), as amended by subsection 
(a), is amended by adding the following at the end of paragraph (4): 
``Such panel shall be scheduled to meet at least 4 times each calendar 
year to consider among other things the approval of applications 
submitted to the Secretary under this subsection. Such meetings shall, 
to the extent possible, be scheduled at equal intervals throughout the 
year.''.
    (c) Section 515(d) (21 U.S.C. 360e(d)) is amended by redesignating 
paragraphs (2) and (3) as paragraphs (5) and (6), respectively, and by 
inserting 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 their receipt:
            ``(A) The Secretary shall make a determination within 30 
        days of receipt of an application submitted under subsection 
        (c) of whether the application satisfies the content 
        requirements of subsection (c)(1) and applicable regulations.
            ``(B) The Secretary shall meet with an applicant 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 provide an applicant the 
        opportunity for a meeting 115 days after receipt of an 
        application which has been accepted for filing under subsection 
        (c) to inform the applicant of the status of the application, 
        advise the applicant of any deficiencies in the application not 
        previously communicated to the applicant, review proposed 
        labeling for the device, and review the actions taken to 
        correct deficiencies identified at the meeting held on the 90th 
        day after receipt of the filed application.
            ``(D) The Secretary shall refer an application to a panel 
        established under section 513 for review and for an approval 
        recommendation, unless a panel is not required under subsection 
        (c)(2), within 30 days of the meeting referenced in 
        subparagraph (B) or at the next scheduled panel meeting 
        following such meeting, whichever is later.
            ``(E) The Secretary shall meet with the applicant within 30 
        days of the panel review if the Secretary has determined that 
        the application is not in a form that would require approval 
        under this subsection. 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 
        could be approved.
            ``(F) The Secretary shall meet within 10 days of the panel 
        review to present to an applicant a description of all 
        additional information necessary to require an approval of an 
        application under this subsection 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, within 30 days of the 
        panel review, such information.
            ``(G) The Secretary shall meet with the applicant no later 
        than 150 days after receipt of an application which has been 
        accepted for filing under subsection (c), if an advisory panel 
        is not required under subsection (c)(2), and inform the 
        applicant whether or not the application is in a form that 
        could be approved under this subsection. 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 this 
        subsection. 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 the approval of the 
        application and the additional information necessary to bring 
        the application into a form that could be approved.
            ``(H) The Secretary shall issue an order either approving 
        or denying an application within 180 days of receipt of an 
        application that has been accepted for filing.
    ``(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 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 
Secretary 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.
    ``(4) In order to better treat or diagnose life-threatening or 
irreversibly debilitating diseases or conditions of man, the Secretary 
shall promulgate regulations 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 regulations shall include criteria for identifying devices which 
merit preferential review and shall specify procedures for implementing 
such reviews. The Secretary shall publish in the Federal Register a 
proposed regulation no later than 6 months after the date of enactment 
of the paragraph, allowing 60 days for comment. The Secretary shall 
publish a final regulation no later than 60 days after the last day of 
the comment period.''.
    (d) Section 515(d) (21 U.S.C. 360e(d)) is amended by adding before 
the semicolon at the end of paragraph (5)(B) the following: ``(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)''.
    (e) The Secretary of Health and Human Services shall revise, 
through notice and comment procedures, the regulations appearing in 
title 21 of the Code of Federal Regulations, part 814, to conform the 
regulations to the amendments of section 515 of the Federal Food, Drug, 
and Cosmetic Act made by this section and to eliminate premarket 
approval of supplements which relate to manufacturing changes and other 
changes which do not actually affect device safety or effectiveness.

SEC. 9. INVESTIGATIONAL DEVICE EXEMPTIONS.

    Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at the end 
the following:
    ``(6) The Secretary of Health and Human Services shall, within 120 
days of the date of enactment of this paragraph, by regulation amending 
the content of parts 812 and 813 of title 21 of the Code of Federal 
Regulations, update the procedures and conditions under which devices 
intended for human use may upon application be granted an exemption 
from certain requirements under the Act. Such regulation shall--
            ``(A) permit the use of investigational devices, outside of 
        the 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 local institutional review board;
            ``(B) require that prior to submitting an application to 
        the Secretary, any person intending to investigate the safety 
        or effectiveness of a class III device or an implant may submit 
        an investigational plan, including clinical protocol, to the 
        Secretary for review; and
            ``(C) provide a submitter who disputes the Secretary's 
        response under subparagraph (B) a right to appear before an 
        advisory committee of the investigational plan and the 
        Secretary's evaluation of such plan.
Within 30 days of receipt of an investigational plan under subparagraph 
(B), the Secretary shall 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.''.

SEC. 10. CLASSIFICATION AND RECLASSIFICATION OF IN VITRO DIAGNOSTIC 
              TEST SYSTEMS.

    (a) Section 513 (21 U.S.C. 360c) is amended by adding at the end 
the following:

 ``initial classification and reclassification of in vitro diagnostic 
                              test systems

    ``(j) Any class III in vitro diagnostic test system intended for 
human use which was introduced or delivered for introduction into 
interstate commerce for commercial distribution before the date of 
enactment of this paragraph is deemed to be automatically reclassified 
by the Secretary in class II on the date 1 year after the date of 
enactment of this subsection unless the Secretary, by regulation, finds 
that classification of the device in class III is necessary to provide 
reasonable assurance of its safety and effectiveness. Any such device 
that the Secretary classifies in class III shall remain in class III 
for 3 years after the effective date of the regulation classifying the 
device in class III. At the end of the 3-year period, the device is 
deemed to be automatically reclassified by the Secretary in class II 
unless the Secretary, by notice and comment rulemaking, extends the 
class III designation for an additional period of time. Any proposed 
regulation issued under this subsection finding that a device shall be 
classified in class III shall be accompanied by a full statement of the 
reasons (and supporting documentation and data) of the Secretary for 
finding that classification of the device in class III is necessary to 
provide reasonable assurance of its safety and effectiveness and that 
reclassification in class II will not provide such assurance.

                            ``classification

    ``(k) Any in vitro diagnostic test system intended for human use 
which is intended to be introduced or delivered for introduction into 
interstate commerce for commercial distribution on or after the date of 
enactment of this subsection is deemed to be classified by the 
Secretary in class II unless the Secretary, by regulation, finds that 
classification of the device in class III is necessary to provide 
reasonable assurance of its safety and effectiveness. Any such device 
that the Secretary classifies in class III shall remain in class III 
for 3 years after the effective date of the regulation classifying the 
device in class III. At the end of that 3-year period, the device is 
deemed to be automatically reclassified by the Secretary in class II 
unless the Secretary, by notice and comment rulemaking, extends the 
class III designation for an additional period of time. Any proposed 
regulation issued under this subsection finding that a device shall be 
classified in class III shall be accompanied by a full statement of the 
reasons (and supporting documentation and data) of the Secretary for 
finding that classification in class II will not provide such 
assurance.''.
    (b) Section 520(l)(1) (21 U.S.C. 360j(l)(1)) is amended by adding 
after ``has classified such device in class I or II'' the following: 
``, except that any device intended for human use described in 
subparagraphs (A) through (F) which is an in vitro diagnostic test 
system is deemed to be classified by the Secretary in class II on the 
date 1 year after the date of enactment of this paragraph unless the 
Secretary in response to a petition submitted under paragraph (2) has 
classified such device in class I, or the Secretary, by regulation, 
finds that classification of the device in class III is necessary to 
provide reasonable assurance of its safety and effectiveness. Any such 
device that the Secretary classifies in class III shall remain in class 
III for 3 years after the effective date of the regulation classifying 
the device in class III. Any such device that the Secretary classifies 
in class III shall remain in class III for 3 years after the effective 
date of the regulation classifying the device in class III unless the 
Secretary, by notice and comment rulemaking, extends the class III 
designation for an additional period of time. At the end of that 3-year 
period, the device is deemed to be automatically reclassified by the 
Secretary in class II. Any proposed regulation issued under this 
paragraph finding that a device shall be classified in class III shall 
be accompanied by a full statement of the reasons (and supporting 
documentation and data) of the Secretary for finding that 
classification of the device in class III is necessary to provide 
reasonable assurance of its safety and effectiveness and that 
reclassification in class II will not provide such assurance''.
SEC. 11. REGULATION OF SPECIAL PURPOSE REAGENTS.

    Section 513 (21 U.S.C. 360c), as amended by section 8, is amended 
by adding at the end the following:

                       ``special purpose reagents

    ``(l) Any special purpose reagent is deemed to be classified by the 
Secretary in class I, subject to the `general controls' defined in 
subsection (h), except the premarket notification requirement of 
section 510(k), if--
            ``(1) the labeling complies with all requirements that the 
        Secretary, by regulation, establishes for in vitro diagnostic 
        test systems, including a requirement that a certificate of 
        analysis provided by the manufacturer of the special purpose 
        reagent shall be limited to a description of the physical and 
        chemical properties of the device, the quantity provided, 
        appropriate storage instruction, expiration date, and the 
        results of any quality or purity testing conducted by the 
        manufacturer;
            ``(2) the label for the device bears the statement `For 
        manufacturing or laboratory use only,'; and
            ``(3) distribution of the device is restricted to 
        laboratories licensed by the Secretary under section 353 of the 
        Public Health Service Act to perform `high complexity' testing 
        as the Secretary, by regulation, defines.

                   ``in vitro diagnostic test system

    ``(m) Any laboratory licensed by the Secretary under section 353 of 
the Public Health Services Act to perform `high complexity' testing 
which uses a special purpose reagent to manufacture an in vitro 
diagnostic test system only for use in that laboratory shall validate 
the in vitro diagnostic test system. The laboratory shall include the 
following statement on all labeling and any patent test report: 
`Proprietary assay developed and validated by [name of laboratory]. The 
performance characteristics of this assay have not been cleared or 
approved by the Food and Drug Administration'.''.

SEC. 12. AUTHORIZATION OF NONGOVERNMENTAL ORGANIZATIONS AND PERSONS TO 
              CONDUCT GOOD MANUFACTURING PRACTICE INSPECTIONS AND 
              RESPONSES TO ADVERSE FINDINGS.

    Section 704 (21 U.S.C. 374) is amended--
            (1) in subsection (a)(1), by inserting ``or organizations 
        and individuals receiving accreditation 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 the accredited 
        organization or individual under section 712,'' after 
        ``employee'';
            (4) in subsection (b), by inserting ``(1)'' after ``(b)'', 
        redesignating clauses (1) and (2) as clauses (A) and (B), 
        respectively, and adding at the end the following:
    ``(2) The Secretary shall provide at least 10 days from the date of 
presentation of the findings in paragraph (1) for the person receiving 
such findings to respond. The Secretary shall take no regulatory action 
against a person or article subject to the requirements of the Act 
until completing a review of such a 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 findings identified in paragraph (1), a 
detailed assessment of the response.
    ``(3) At the time an accredited organization or individual shall 
identify in writing each inspectional finding observed during such 
inspection which suggests a deviation from requirements under the Act. 
Within 30 days from the date of presentation of such findings, the 
person receiving the findings shall respond in writing to the 
accredited organization or individual stating the response of such 
person to each finding. Within 30 days of receipt of such response, the 
accredited organization or individual shall prepare and submit a 
written report to the Secretary, including inspectional findings, the 
regulated person's response to the findings, an assessment of the 
adequacy of the response and conclusions, and a copy of the conflict of 
interest assessment prepared in accordance with the requirement set 
forth in section 712(c). Such accredited organization or individual 
shall immediately submit to the Secretary the inspectional findings 
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 any regulated 
article could present an unreasonable and substantial risk of injury or 
illness to the public health.''; and
            (5) by adding after subsection (e) 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.''.

SEC. 13. ACCREDITATION OF NONGOVERNMENTAL ORGANIZATIONS OR INDIVIDUALS.

    Subchapter A of chapter VII is amended by adding the following:

    ``accreditation of nongovernmental organizations or individuals

    ``Sec. 712. (a) The Secretary shall, within 180 days after the date 
of enactment of this section, by regulation establish procedures and 
criteria to accredit any organization or individuals for purposes of--
            ``(1) conducting good manufacturing practice inspections 
        authorized under section 704 to determine the conformance of a 
        facility with regulations promulgated under section 520(f);
            ``(2) reviewing notifications required under section 510(k) 
        and making written recommendations of initial classification 
        under section 513(f)(1) of devices; and
            ``(3) reviewing applications under section 515(c) and 
        providing written reviews to the Secretary determine, within 
        120 days from the receipt of a submission requesting 
        accreditation, whether the organization or individual 
        submitting such application is fit to undertake some or all of 
        the activities specifies herein. The Secretary shall notify the 
        applicant in writing of the Secretary's determination within 
        such time period.
    ``(b) The Secretary shall take into account the training and 
experience of organizations and individuals who apply for 
accreditation, including formal education, certifications, work 
experience, ability to protect the confidentiality of trade secret and 
confidential commercial and financial information, lack of bias and 
other related information necessary to determine the fitness of an 
applicant to undertake activities on behalf of the Department of Health 
and Human Services.
    ``(c) Notwithstanding the credentials or qualifications of any 
applicant, the Secretary shall, after accreditation require each person 
who chooses to use an accredited organization or individual to 
determine whether such organization or individual has a significant 
personal or financial interest in a device, other than compensation for 
reviews or inspections, that would influence decisions regarding such 
device.''.

SEC. 14. RESEARCH ACTIVITIES.

    (a) Activities.--Chapter IX, as amended by section 11, is amended 
by adding after section 906 the following:

                         ``research activities

    ``Sec. 907. Research activities of the Food and Drug Administration 
relating to drugs, devices, and biological products, which are 
authorized under section 903(b)(2)(D) and section 352 of the Public 
Health Service Act, shall directly relate to the review and approval of 
drugs, devices, and biological products. In conducting such research 
activities, the Food and Drug Administration may collaborate with the 
National Institutes of Health, academic health centers, and other 
scientific institutions and the drug and device industry.''.
    (b) Purpose.--Section 903 (21 U.S.C. 393), as amended by section 3, 
is amended by adding at the end the following:
    ``(e) Any research conducted by or for the Food and Drug 
Administration shall be solely related directly to (1) the regulatory 
mission or (2) professional staff development related to that mission 
and shall be limited to the minimum necessary to achieve such 
purposes.''.

SEC. 15. POLICY AND PERFORMANCE REVIEW.

    Section 514 (21 U.S.C. 360d) is amended by adding the following:
    ``(c)(1) The Secretary shall recognize applicable nationally or 
internationally recognized consensus standards to determine whether 
there is a reasonable assurance that a device is safe or effective or 
to determine compliance with any requirement under the Act, except 
that, any person may elect to submit data other than that required by 
such standards to demonstrate a reasonable assurance of device safety 
or effectiveness or compliance with requirements under the Act.
    ``(2) The Secretary in lieu of receiving data demonstrating 
conformance to standards referenced in paragraph (1) shall accept 
certifications from regulated persons that devices conform with each 
standard identified in each such certification.
    ``(d) The Secretary shall not rely upon informal agency statements, 
including guidance documents, policy statements, points to consider 
documents, or any other statements intended for a similar purpose, to 
require any action be taken to satisfy a requirement under the Act, 
unless such statement is first subject to the rulemaking procedure set 
forth in section 5 U.S.C. e 553.''.

SEC. 16. EXPORT OF NEW DRUGS AND DEVICES.

    Section 801(e) (21 U.S.C. 381(e)) is amended--
            (1) in paragraph (1), by inserting after ``under this Act'' 
        the following: ``or in violation of section 505 or section 351 
        of the Public Health Service Act'',
            (2) in paragraph (1), by striking the last sentence, and
            (3) by amending paragraph (2) to read as follows:
    ``(2) Paragraph (1) does not apply to the export of--
            ``(A) any device--
                    ``(i) which does not comply with an applicable 
                requirement under section 514 or 515,
                    ``(ii) which under section 520(g) is exempt from 
                either such section, or
                    ``(iii) which is a banned device under section 516, 
                or
            ``(B) any drug (including a biological product) which does 
        not comply with an applicable requirement under section 505 or 
        512 or section 351 of the Public Health Service Act,
unless the device or drug is in compliance with the requirements of 
paragraph (1). In the case of a device or drug for which an export 
notice is required under this paragraph, the Secretary may prohibit the 
export of such device or drug if the Secretary determines that the 
possibility of the reimportation of the device or drug into the United 
States presents an imminent hazard to the public health and safety of 
the United States and the only means of limiting the hazard is to 
prohibit the export of the device or drug.''.

SEC. 17. RECLASSIFICATION OF CERTAIN DEVICES.

    Section 515 (21 U.S.C. 360e) is amended by adding at the end the 
following new subsection:

                           ``reclassification

    ``(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, unless the Secretary has already published a 
proposed regulation required under subsection (i) for each such device. 
The Secretary shall provide 60 days for comment on the proposed 
regulation, 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 regulation required 
under subsection (i), or maintaining, where appropriate, the original 
classification of such devices.''.

SEC. 18. TRACKING.

    (a) Section 519(e) is amended to read as follows:
    ``(e) Every person who registers under section 510 and is engaged 
in the manufacture of a class II or class III device the failure of 
which would be reasonably likely to have life threatening or 
permanently debilitating health consequences attributable to the device 
and which is a permanently implantable device, or a life sustaining or 
life supporting device used outside a device user facility, or may 
designate, shall adopt a method of device tracking. Manufacturers 
subject to tracking may satisfy the requirements of this subsection by 
relying exclusively on social security numbers as a method of device 
tracking.''.
    (b) The Secretary of Health and Human Services shall, within 12 
months of the date of the enactment of this Act, revise regulations 
appearing in part 821 of title 21 of the Code of Federal Regulations, 
to conform to section 519 of the Federal Food, Drug, and Cosmetic Act 
as amended by subsection (a).
    (c) Section 205(c)(2)(C)(vii) (42 U.S.C. e 405(c)(2)(C)(viii)) of 
the Social Security Act is amended by redesignating subclauses (II), 
(III), and (IV) as (III), (IV), and (V), and inserting after subclause 
(I) the following new subclause:
    ``(II) Section 519(e) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360i(e)) is exempted from subclause (I). Social Security 
account numbers and related records obtained or maintained by 
authorized persons shall be available for use under section 519(e) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(e)) for 
purposes of device tracking. The requirements under section 7(b) of the 
Privacy Act of 1974 (Public Law No. 93-579, 88 Stat. 1896), shall not 
apply to any Federal, State, or local government agency requesting a 
person to disclose his/her social security account number for purposes 
of device tracking under section 519(e) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360i(e)).''.

SEC. 19. POSTMARKET SURVEILLANCE.

    Section 522 (21 U.S.C. 360l) is amended to read as follows:

                       ``postmarket surveillance

    ``Sec. 522. (a) The Secretary may require a manufacturer to conduct 
postmarket surveillance for any device of the manufacturer first 
introduced or delivered for introduction into interstate commerce after 
January 1, 1991, that is a class III device the failure of which would 
be reasonably likely to have life threatening or permanently 
debilitating consequences attributable to the device and which is (1) a 
permanently implantable device, or (2) a life sustaining or life 
supporting device used outside a device user facility.
    ``(b) 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 and submit, for the approval of the Secretary, a protocol 
for the required surveillance. The Secretary, within 60 days of the 
receipt of such protocol, shall determine if the principal investigator 
proposed to be used in the surveillance has sufficient qualifications 
and experience to conduct such surveillance and if such protocol will 
result in collection of useful data or other information necessary to 
protect the public health and to provide safety and effectiveness 
information for the device. The Secretary may not approve such a 
protocol until it has been reviewed by an appropriately qualified 
scientific and technical review committee established by the 
Secretary.''.

SEC. 20. MISCELLANEOUS.

    (a) Chapter III of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355 et seq.) is amended by adding at the end thereof the 
following new sections:

   ``dissemination of treatment information on drugs and biological 
                                products

    ``Sec. 311. (a)(1) Notwithstanding sections 301(d), 502(f), 505, 
and 507 and section 351 of the Public Health Service Act (42 U.S.C. 
262), and subject to the requirements of paragraph (2) and subsection 
(b), a person may disseminate to any person that is a health care 
practitioner or other provider of health care goods or services, a 
pharmacy benefit manager, a health maintenance organization or other 
managed health care organization, or a health care insurer or 
governmental agency, written information, or an oral or written summary 
of the written information, concerning--
            ``(A) a treatment use for an investigational new drug or an 
        investigational biological product approved by the Secretary 
        for such treatment use; or
            ``(B) a use (whether or not such use is contained in the 
        official labeling) of a new drug (including any antibiotic 
        drug) or a biological product for which an approval of an 
        application filed under section 505(b), 505(j), or 507, or a 
        product license issued under the Public Health Service Act, is 
        in effect.
    ``(2) A person may disseminate information under paragraph (1)(B) 
only if--
            ``(A) the information is an unabridged--
                    ``(i) reprint or copy of a peer-reviewed article 
                from a scientific or medical journal that is published 
                by an organization that is independent of the 
                pharmaceutical industry; or
                    ``(ii) chapter, authored by an expert or experts in 
                the disease to which the use relates, from a recognized 
                reference textbook that is published by an organization 
                that is independent of the pharmaceutical industry;
            ``(B) the text of the information has been approved by a 
        continuing medical education accrediting agency that is 
        independent of the pharmaceutical industry as part of a 
        scientific or medical educational program approved by such 
        agency;
            ``(C) the information relates to a use that is recognized 
        under Federal law for purposes of third-party coverage or 
        reimbursement, and--
                    ``(i) the text of the information has been approved 
                by an organization referred to in such Federal law; or
                    ``(ii) the information is part of a disease 
                management program or treatment guideline with respect 
                to such use; or
            ``(D) the information is an accurate and truthful summary 
        of the information described in subparagraph (A), (B), or (C).
    ``(b) In order to afford a full and fair evaluation of the 
information described in subsection (a), a person disseminating the 
information shall include a statement that discloses--
            ``(1) if applicable, that the use of a new drug or 
        biological product described in subparagraph (A) or (B) of 
        subsection (a)(1) and the information with respect to the use 
        have not been approved by the Food and Drug Administration;
            ``(2) if applicable, that the information is being 
        disseminated at the expense of the sponsor of the drug or 
        biological product;
            ``(3) if applicable, that one or more authors of the 
        information being disseminated are employees of or consultants 
        to the sponsor of the drug or biological product; and
            ``(4) the official labeling for the drug and biological 
        product, or in the case of a treatment use of an 
        investigational drug or biological product, the investigator 
        brochure and all updates thereof.
    ``(c) As used in this section, the term `expense' includes 
financial, in-kind, and other contributions provided for the purpose of 
disseminating the information described in subsection (a).
    ``(d) In the case of a professional disagreement between the 
Secretary and other qualified experts with respect to the application 
of section 502(a), the Secretary may not use section 502 to prohibit 
the dissemination of information in the types of circumstances and 
under the conditions set forth in subsections (a) and (b).

               ``dissemination of information on devices

    Sec. 312. (a) Notwithstanding sections 301, 501(f), 501(i), 502(a), 
502(f), and 502(o), or any other provision of law, and subject to 
subsections (b) and (c), a person may disseminate to any person that is 
a health care practitioner or other provider of health care goods or 
services, a pharmacy benefit manager, a health maintenance organization 
or other managed health care organization, or a health care insurer or 
governmental agency, written or oral information (including information 
exchanged at scientific and educational meetings, workshops, or 
demonstrations) relating to a use, whether or not the use is described 
in the official labeling, of a device produced by a manufacturer 
registered pursuant to section 510.
    ``(b)(1) To the extent practicable, the requirement with respect to 
a statement of disclosure under subsection (b) of section 311 shall 
apply to the dissemination of written and oral information under this 
section, except that this paragraph shall not apply to the 
dissemination of written or oral information with respect to the 
intended use described in the labeling of a device.
    ``(2) A person may disseminate information under subsection (a) 
only if--
            ``(A) the information is an unabridged--
                    ``(i) reprint or copy of a peer-reviewed article 
                from a scientific or medical journal that is published 
                by an organization that is independent of the medical 
                device industry; or
                    ``(ii) chapter, authored by an expert or experts in 
                the medical specialty to which the use relates, from a 
                recognized reference textbook that is published by an 
                organization that is independent of the medical device 
                industry;
            ``(B) the information has been approved by a continuing 
        medical education accrediting agency that is independent of the 
        medical device industry as part of a scientific or medical 
        educational program approved by such agency;
            ``(C) the information relates to a use that is recognized 
        under Federal law for purposes of third-party reimbursement, 
        and--
                    ``(i) the text of the information has been approved 
                by an organization referred to in such Federal law; or
                    ``(ii) the information is part of a disease 
                management program or treatment guideline with respect 
                to such use; or
            ``(D) the oral or written information is--
                    ``(i) part of an exchange of information solely 
                among health care practitioners, health care 
                reimbursement officials, and the industry;
                    ``(ii) exchanged for educational or scientific 
                purposes; and
                    ``(iii) presented at continuing medical education 
                programs, seminars, workshops, or demonstrations.
    ``(3) The requirements under subsection (a)(1)(A) and (B) of 
section 311 shall not apply with respect to devices.
    ``(c) Notwithstanding section 502(a), 502(f), 502(o), or any other 
provision of law, the written or oral dissemination of information 
relating to a new use of a device, in accordance with this section, 
shall not be construed by the Secretary as evidence of a new intended 
use of the device that is different from the intended use of the device 
set forth on the official labeling of the device. Such dissemination 
shall not be considered by the Secretary as labeling, adulteration, or 
misbranding of the device.''.
    (b) Section 519 (21 U.S.C. 360i) is amended to read as follows:

                    ``records and reports on devices

    ``Sec. 519. (a) Every person who is a manufacturer or importer, of 
a device intended for human use shall establish and maintain such 
records, make such reports, and provide such information, as the 
Secretary may by regulation reasonably require to assure that such 
device is not adulterated or misbranded and to otherwise assure its 
safety and effectiveness. Regulations prescribed under the preceding 
sentence--
            ``(1) shall require a device manufacturer or importer to 
        report to the Secretary whenever the manufacturer or importer 
        receives or otherwise becomes aware of information that 
        reasonably suggests that one of its marketed devices may have 
        caused or contributed to a death or serious injury;
            ``(2) shall define the term `serious injury' to mean an 
        injury that--
                    ``(A) is life threatening,
                    ``(B) results in permanent impairment of a body 
                function or permanent damage to a body structure, or
                    ``(C) necessitates medical or surgical intervention 
                to preclude permanent impairment of a body function or 
                permanent damage to a body structure;
            ``(3) shall require reporting of other significant adverse 
        device experiences as determined by the Secretary to be 
        necessary to be reported;
            ``(4) shall not impose requirements unduly burdensome to a 
        device manufacturer or importer taking into account his cost of 
        complying with such requirements and the need for the 
        protection of the public health and the implementation of this 
        Act;
            ``(5) which prescribe the procedure for making requests for 
        reports or information shall require that each request made 
        under such regulations for submission of a report or 
        information to the Secretary state the reason or purpose for 
        such request and identify to the fullest extent practicable 
        such report or information;
            ``(6) which require submission of a report or information 
        to the Secretary shall state the reason or purpose for the 
        submission of such report or information and identify to the 
        fullest extent practicable such report or information;
            ``(7) may not require that the identity of any patient be 
        disclosed in records, reports, or information required under 
        this subsection unless required for the medical welfare of an 
        individual, to determine the safety or effectiveness of a 
        device, or to verify a record, report, or information submitted 
        under this Act;
            ``(8) may not require a manufacturer, importer, or 
        distributor of a class I device to--
                    ``(A) maintain for such a device records respecting 
                information not in the possession of the manufacturer 
                or importer, or
                    ``(B) to submit for such a device to the Secretary 
                any report or information--
                            ``(i) not in the possession of the 
                        manufacturer or importer, or
                            ``(ii) on a periodic basis,
        unless such report or information is necessary to determine if 
        the device should be reclassified or if the device is 
        adulterated or misbranded; and
    ``(b) Subsection (a) shall not apply to--
            ``(1) any practitioner who is licensed by law to prescribe 
        or administer devices intended for use in humans and who 
        manufactures or imports devices solely for use in the course of 
        his professional practice;
            ``(2) any person who manufactures or imports devices 
        intended for use in humans solely for such person's use in 
        research or teaching and not for sale (including any person who 
        uses a device under an exemption granted under section 520(g)); 
        and
            ``(3) any other class of persons as the Secretary may by 
        regulation exempt from subsection (a) upon a finding that 
        compliance with the requirements of such subsection by such 
        class with respect to a device is not necessary to (A) assure 
        that a device is not adulterated or misbranded or (B) otherwise 
        to assure its safety and effectiveness.
    ``(c) Each manufacturer and importer required to make reports under 
subsection (a) shall submit to the Secretary annually a statement 
certifying that--
            ``(1) the manufacturer or importer did file a certain 
        number of such reports, or
            ``(2) the manufacturer or importer did not file any report 
        under subsection (a).
    ``(d) Every person who registers under section 510 and is engaged 
in the manufacture of--
            ``(1) a device the failure of which would be reasonably 
        likely to have serious adverse health consequences and which is 
        (A) a permanently implantable device, or (B) a life sustaining 
        or life supporting device used outside a device user facility, 
        or
            ``(2) any other device which the Secretary may designate,
shall adopt a method of device tracking.''.
    (b) Within 120 days after the enactment of this section, the 
Secretary shall delete all regulations in title 21, part 800 requiring 
distributors, other than importers, to make reports of deaths, serious 
injuries or illness, and malfunctions related to devices.
    (c) Section 303(c) (21 U.S.C. 333) is amended by striking the 
period at the end of subsection (c) and inserting ``; or for having 
violated 301(a), (b), (c), and (k), by failure to comply with either 
subsections 502(t)(2) or 501(h), or having violated subsection 
301(g)(1)(B) by failing to furnish material or information required 
under subsection 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.''.
    (d) Section 201(h) (21 U.S.C. 321(h)) is amended by striking 
paragraph (1), and renumbering paragraphs (2), and (3) as paragraphs 
(1) and (2), respectively.
    (e) The Secretary of Health and Human Services within 120 days of 
the enactment of this section shall revise all regulations appearing in 
part 800 of title 21 of the Code of Federal Regulations to delete any 
requirement to report device malfunctions.
                                 <all>
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HR 2290 IH----3
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