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





                                                 Union Calendar No. 178

105th CONGRESS

  1st Session

                               H. R. 1710

                          [Report No. 105-307]

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                            October 6, 1997

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed
                                                 Union Calendar No. 178
105th CONGRESS
  1st Session
                                H. R. 1710

                          [Report No. 105-307]

  To amend the Federal Food, Drug, and Cosmetic Act to facilitate the 
development, clearance, and use of devices to maintain and improve the 
public health and quality of life of the citizens of the United States.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 22, 1997

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

                            October 6, 1997

 Additional sponsors: Mr. Fazio of California, Mr. Gekas, Mr. Holden, 
 Mr. Sawyer, Mr. Peterson of Minnesota, Mr. Cunningham, Mr. McGovern, 
    Mr. Campbell, Mr. Buyer, Mr. Archer, Mr. Gutknecht, Mr. Farr of 
   California, Mr. Frost, Mr. Frank of Massachusetts, Mr. Canady of 
Florida, Mr. Cramer, Mr. McHale, Mr. Foley, Mr. Neal of Massachusetts, 
Mr. Hayworth, Mr. McKeon, Mr. Stump, Mr. Taylor of North Carolina, Mr. 
Horn, Mr. Boehner, Mr. Franks of New Jersey, Mr. Hostettler, Mr. Watts 
of Oklahoma, Mr. Lucas of Oklahoma, Mr. Doolittle, Mr. Thornberry, Mr. 
  Royce, Mr. Burton of Indiana, Mr. Saxton, Mr. DeLay, Mr. Brady, Mr. 
  Moakley, Mr. Meehan, Mr. Baesler, Mr. Ballenger, Mr. Sessions, Mr. 
Bonilla, Mr. Hutchinson, Ms. Granger, Mrs. Johnson of Connecticut, Mr. 
   Porter, Mr. Dooley of California, Mr. Combest, Mr. McIntosh, Mrs. 
 Myrick, Mr. Duncan, Mr. Gibbons, Mr. Shays, Mr. Kleczka, Mr. Forbes, 
Mr. Sam Johnson, Mr. Luther, Mr. Herger, Mr. Kolbe, Mr. Smith of Texas, 
Mr. Calvert, Mr. Sensenbrenner, Mr. Weldon of Florida, Mr. Clyburn, Mr. 
   Ehlers, Mr. Talent, Mrs. Tauscher, Mrs. Roukema, Mr. Spence, Mr. 
 Stenholm, Mr. Kind of Wisconsin, Mr. Tanner, Mr. Dreier, Ms. Danner, 
   Mr. Pascrell, Ms. Eddie Bernice Johnson of Texas, Mr. Minge, Mr. 
   Pickering, Mr. Menendez, Mrs. Kelly, Ms. Dunn of Washington, Mr. 
   Graham, Mr. Bunning of Kentucky, Mr. Rothman, Mr. Etheridge, Mr. 
       Packard, Mr. Hoekstra, Mr. Hansen, Mr. Cook, Mr. Kim, Mr. 
 Frelinghuysen, Mr. Reyes, Ms. Sanchez, Mr. Capps, Mrs. Chenoweth, Mr. 
     Miller of Florida, Mr. Hunter, Mr. Goodling, Mr. Bishop, Mr. 
Rohrabacher, Mr. Solomon, Mr. Sununu, Mr. Christensen, Mr. Thomas, Mrs. 
 Northup, Mr. Pitts, Mr. Souder, Mr. Berman, Mr. Fawell, Mr. Aderholt, 
                  Mr. Cannon, Mr. Wamp, and Mr. Matsui

                            October 6, 1997

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]
[For text of introduced bill, see copy of bill as introduced on May 22, 
                                 1997]

_______________________________________________________________________

                                 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; REFERENCES; TABLE OF CONTENTS.

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

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

SEC. 2. FDA MISSION AND ANNUAL REPORT.

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

SEC. 3. DISPUTE RESOLUTION.

    Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after 
section 506 the following:

                          ``dispute resolution

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

SEC. 4. INVESTIGATIONAL DEVICE EXEMPTIONS; EXPANDED ACCESS.

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

SEC. 5. SPECIAL REVIEW FOR CERTAIN DEVICES.

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

SEC. 6. EXPANDING HUMANITARIAN USE OF DEVICES.

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

SEC. 7. DEVICE STANDARDS.

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

                   ``Listing of Recognized Standards

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

SEC. 8. SCOPE OF REVIEW.

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

SEC. 9. PREMARKET NOTIFICATION.

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

SEC. 10. CLASSIFICATION PANELS.

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

SEC. 11. PREMARKET APPROVAL.

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

SEC. 12. ACCREDITATION FOR ACCREDITED PERSONS.

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

                          ``accredited persons

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

SEC. 13. PREAMENDMENT DEVICES.

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

                               ``Revision

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

SEC. 14. DEVICE TRACKING.

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

                           ``Device Tracking

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

SEC. 15. POSTMARKET SURVEILLANCE.

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

                       ``postmarket surveillance

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

SEC. 16. HARMONIZATION.

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

SEC. 17. REPORTS.

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

SEC. 18. INFORMATION SYSTEM.

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

``SEC. 906. INFORMATION SYSTEM.

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

SEC. 19. PRACTICE OF MEDICINE.

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

``SEC. 907. PRACTICE OF MEDICINE.

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

SEC. 20. CLARIFICATION OF DEFINITION.

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

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

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

SEC. 22. NONINVASIVE BLOOD GLUCOSE METER.

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

SEC. 23. RULE OF CONSTRUCTION.

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