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 Commit-
tee 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 develop-
ment, 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. GOR-
DON, Mr. EHRLICH, Mr. RAMSTAD, Mr. WYNN, Ms. MCCARTHY of Mis-
souri, and Mr. PALLONE) introduced the following bill; which was re-
ferred 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. MCGOV-
ERN, 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. TAY-
LOR of North Carolina, Mr. HORN, Mr. BOEHNER, Mr. FRANKS of New
Jersey, Mr. HOSTETTLER, Mr. WATTS of Oklahoma, Mr. LUCAS of Okla-
homa, 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 Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CON-
TENTS.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Medical Device Regulatory Modernization Act of 1997’’.
(b) REFERENCE.—Whenever in this Act an amend-
ment 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 require-
ments.
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 amend-
ed 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, har-
monize 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, simulta-
neously 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 Com-
mittee 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 poli-
cies 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 bur-
den of regulation, to harmonize regulation, and to
seek appropriate reciprocal arrangements,
‘‘(B) describe the goals, activities, and accom-
plishments of the Food and Drug Administration in
such meetings, and
‘‘(C) list issues that the Food and Drug Admin-
istration 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 in-
serting 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 promul-
gated 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 manu-
facturer 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 man-
ner. 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; 
EX-
PANDED ACCESS.
Section 520(g) (21 U.S.C. 360j(g)) is amended by add-
ing 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 sub-
section is in effect, the following:
‘‘(i) Procedures and conditions under which the
Secretary will, without requiring an additional ap-
proval of an application for an exemption or the ap-
proval of a supplement to such an application, per-
mit—
‘‘(I) developmental changes in the device
that do not constitute a significant change in de-
sign 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 rela-
tionship 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 ir-
reversibly 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 de-
vice; and that there is no legally marketed device
alternative for the satisfactory treatment or diag-
nosis 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 in-
vestigational use of the device will not interfere
with the initiation, conduct, or completion of
clinical investigations to support marketing ap-
proval; 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 regula-
tions promulgated under such paragraph de-
scribing the investigational use of devices in a
single patient or a small group of patients.
‘‘(B) Regulations under subparagraph (A)(i) shall pro-
vide that a change or modification described in such sub-
paragraph 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 per-
son has an opportunity, prior to submitting an application
to the Secretary or to an institutional review board, to sub-
mit 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 Sec-
retary shall meet with the applicant not later than 30 days
after receiving the request for the meeting.
‘‘(B) Agreements regarding the parameters of an inves-
tigational 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 adminis-
trative 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 substan-
tial scientific issue essential to determining the safety
or effectiveness of the device involved has been identi-
fied.
‘‘(C) A decision under subparagraph (B)(ii) by the di-
rector shall be in writing, and may be made only after the
Secretary has provided to the sponsor or applicant an op-
portunity for a meeting at which the director and the spon-
sor or applicant are present and at which the director docu-
ments 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 ex-
isting approved alternatives, or
‘‘(D) the availability of which is in the best in-
terest 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 con-
venes 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 fol-
lows:
‘‘(5) The Secretary may suspend or withdraw an ex-
emption 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 condi-
tion 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 fol-
lows:
‘‘(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 in-
cluded in title 21 of the Code of Federal Regulations per-
taining to humanitarian devices which is inconsistent with
the amendments made by subsection (a) shall be deemed re-
scinded on the date of the enactment of this Act. The Sec-
retary 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 rec-
ognized standards (or portions of such standards) to which
a person may self-certify compliance for the purpose of dem-
onstrating 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 ex-
tent such standard applies, except that the Secretary may,
at any time, require the person who submitted the certifi-
cation to submit the data and information which such per-
son relied upon in making such certification, and may re-
ject 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 stand-
ards adopted under subsection (a) a standard (or portion
of a standard) which the Secretary determines is not reli-
able 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 re-
quired 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 informa-
tion 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 per-
formance 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 fol-
lowing: ‘‘the listing of standards under section
514(c),’’.
(2) RELATIONSHIP
TO
PERFORMANCE
STAND-
ARDS.—Section 514(a) (21 U.S.C. 360d(a)) is amend-
ed—
(A) in paragraph (1), in the second sen-
tence, by striking ‘‘under this section’’ and in-
serting ‘‘under subsection (b)’’;
(B) in paragraph (2), in the matter preced-
ing 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 preced-
ing 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 assur-
ance 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 pa-
rameters 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 adminis-
trative 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 sci-
entific issue essential to determining the safety or ef-
fectiveness 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 ap-
plicant 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 ex-
pedite the classification of devices under subsection (f)(1)
of this section.
‘‘(D) Whenever the Secretary requests information to
demonstrate that devices with differing technological char-
acteristics are substantially equivalent, the Secretary shall
only request information that is necessary to making sub-
stantial equivalence determinations. In making such re-
quest, 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 in-
tended use of a device shall be based upon the proposed la-
beling submitted in a report for the device under section
510(k), unless the director of the organizational unit re-
sponsible for regulating devices (in this subparagraph re-
ferred 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 reason-
able 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 notifica-
tion 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 la-
beling; and
‘‘(III) find the device substantially equivalent
when the labeled intended use and the technological
characteristics of the device relative to a legally mar-
keted device conform with the requirements of sub-
paragraph (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 Moderniza-
tion 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 label-
ing.’’; and
(2) by adding after paragraph (5) (as added by
section 5(2)) the following:
‘‘(6)(A)(i) A supplemental application shall be re-
quired for any change to a device subject to an approved
application under this subsection that affects safety or effec-
tiveness, unless such change is a modification in a manu-
facturing 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, summa-
rizes 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 sub-
mits a notice under clause (i) with respect to a manufactur-
ing 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 accept-
ance 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 re-
ceipt of the supplement. The time used by the Secretary to
review the notice of the manufacturing change shall be de-
ducted 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 supple-
ment to an approved application, for an incremental
change to the design of a device that affects safety or effec-
tiveness, 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 applica-
tion and any supplement to the approved application
provide a reasonable assurance of safety and effective-
ness for the changed device.
‘‘(ii) The Secretary may require, when necessary, ad-
ditional 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 fol-
lowing: ‘‘or person who is accredited under sec-
tion 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 preced-
ing sentence does not apply to any class I device that is
intended to be life supporting or life sustaining or is in-
tended for a use which is of substantial importance in pre-
venting impairment of human health, or to any class I de-
vice 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 re-
port, to the Secretary such person’s recommendation for ac-
tion 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 enact-
ment 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 assur-
ance 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 peti-
tion 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 fol-
lowing: ‘‘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 Sec-
retary. 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 clas-
sified until the Secretary has determined the classi-
fication of the device based on the classification cri-
teria set forth in subparagraphs (A) through (C) of
subsection (a)(1), within 60 days of receiving the re-
quest 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 com-
merce 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, includ-
ing a finding that the facility in which the device is manu-
factured is not in compliance with good manufacturing re-
quirements as set forth in regulations of the Secretary under
section 520(f) (other than a finding that the failure to com-
ply 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 ‘‘clin-
ical data’’ and inserting ‘‘appropriate clinical or sci-
entific data’’ and by inserting ‘‘or a person accredited
under section 712’’ after ‘‘Secretary’’;
(2) in subparagraph (A)(ii)(II), by striking ‘‘ef-
ficacy’’ and inserting ‘‘effectiveness’’; and
(3) by adding at the end of paragraph (1) the
following:
‘‘(F) For purposes of subparagraph (A), the term ‘le-
gally 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 en-
actment 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 add-
ing at the end the following:
‘‘(5) Classification panels covering each type of device
shall be scheduled to meet at such times as may be appro-
priate for the Secretary to meet applicable statutory dead-
lines.
‘‘(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 informa-
tion that are not available for public disclosure under
section 552 of title 5, United States Code);
‘‘(ii) the submission, for review by a classifica-
tion 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 trans-
mittal to the classification panel; and
‘‘(iii) the participation of the persons at meet-
ings of the panel.
‘‘(B) Any meetings of a classification panel shall pro-
vide adequate time for initial presentations and for re-
sponse 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 deci-
sion on the matter in accordance with section 515(d)(2),
and shall notify the affected persons of the decision in writ-
ing 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 re-
quest of the applicant, the Secretary shall meet with an ap-
plicant 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 Med-
ical 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 govern-
ment 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 Medi-
cal 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 ac-
creditation 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 pub-
lic 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 accred-
ited persons and the particular activities under
subsection (a) for which each such person is ac-
credited 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 require-
ments:
‘‘(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 fi-
nancial affiliation with such a manufacturer,
supplier, or vendor.
‘‘(B) Such person shall be a legally con-
stituted entity permitted to conduct the activities
for which it seeks accreditation.
‘‘(C) Such person shall not engage in the de-
sign, manufacture, promotion, or sale of devices.
‘‘(D) Such person shall be operated in ac-
cordance 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 com-
petence 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 carry-
ing out subsection (a) with respect to a de-
vice, of any officer or employee of the person
who has a financial conflict of interest re-
garding the device, and annually make
available to the public disclosures of the ex-
tent to which the person, and the officers
and employees of the person, have main-
tained 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 recommenda-
tion 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 se-
cret to such person; or
‘‘(3) the receipt by a person accredited under sec-
tion 712 of a bribe in any form or the doing of any
corrupt act by such person associated with a respon-
sibility 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 enact-
ment 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 manufac-
turer 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 de-
vice 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 sur-
veillance for any device of the manufacturer which is a class
II or class III device the failure of which would be reason-
ably 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 con-
duct such surveillance, submit, for the approval of the Sec-
retary, 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 ap-
propriate qualifications and experience to undertake such
surveillance and if such plan will result in information nec-
essary 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 be-
tween the Secretary and the manufacturer or, if no agree-
ment can be reached, after the completion of a dispute reso-
lution 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 har-
monize 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 achiev-
ing mutual recognition of good manufacturing practices in-
spections.
‘‘(2) The Secretary shall report to the Committee on
Commerce of the House of Representatives and the Commit-
tee on Labor and Human Resources of the Senate at least
60 days before executing any bilateral or multilateral agree-
ment 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 distribu-
tor’’ 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 para-
graph (5);
(2) by inserting after paragraph (3) the follow-
ing:
‘‘(4) any distributor who acts as a wholesale dis-
tributor of devices, and who does not manufacture, re-
package, process, or relabel a device; or’’; and
(3) by adding at the end the following flush sen-
tence:
‘‘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 an-
nual 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 fol-
lowing paragraph:
‘‘(5) With respect to device user facilities that are hos-
pitals or nursing homes:
‘‘(A) The Secretary shall by regulation plan and
implement a program under which the Secretary lim-
its user reporting under paragraphs (1) through (4)
to a subset of hospitals and nursing homes that con-
stitutes a representative profile of user reports for de-
vice 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 implementa-
tion 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 pro-
gram 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 Mod-
ernization Act of 1997, the Secretary shall submit to
the Committee on Commerce of the House of Rep-
resentatives, and to the Committee on Labor and
Human Resources of the Senate, a report describing
the plan developed by the Secretary under subpara-
graph (A) and the progress that has been made to-
ward the implementation of the plan.’’.
SEC. 18. INFORMATION SYSTEM.
Chapter IX is amended by adding at the end the fol-
lowing 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 determina-
tion 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 de-
vices.’’.
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 COMPLI-
ANCE 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 ar-
tery 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 test-
ing devices creates a disincentive for people with dia-
betes 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 con-
ducted by people with diabetes, particularly children;
and
(9) the Food and Drug Administration is re-
sponsible for reviewing all applications for new medi-
cal devices in the United States.
(b) SENSE OF CONGRESS.—It is the sense of the Con-
gress 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 to-
bacco 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.