I
105TH CONGRESS
1ST SESSION
H. R. 1710
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
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; REFERENCE; 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. 301 et seq.).
(c) TABLE OF CONTENTS.—The table of contents is
as follows:
Sec. 1. Short title; reference; table of contents.
Sec. 2. FDA mission and annual report.
Sec. 3. Dispute resolution.
Sec. 4. Investigational device exemptions.
Sec. 5. Special review for certain devices.
Sec. 6. Expanding humanitarian use of devices.
Sec. 7. Performance standards.
Sec. 8. Scope of review.
Sec. 9. Premarket notification.
Sec. 10. Classification panels.
Sec. 11. Premarket approval.
Sec. 12. Accreditation for accredited persons.
Sec. 13. Preamendment devices.
Sec. 14. Device tracking.
Sec. 15. Postmarket surveillance.
Sec. 16. Harmonization.
Sec. 17. Reports.
Sec. 18. G.M.P. and device reports.
Sec. 19. Information system.
Sec. 20. Environmental impact review.
Sec. 21. Practice of medicine.
Sec. 22. Publication of notice of deviation.
SEC. 2. FDA MISSION AND ANNUAL REPORT.
(a) MISSION.—Section 903 (21 U.S.C. 393) is
amended by redesignating subsections (b) and (c) as sub-
sections (c) and (d), respectively, and by adding after sub-
section (a) the following:
‘‘(b) MISSION.—The Food and Drug Administration
shall protect the public health by ensuring that—
‘‘(1) foods are safe, wholesome, and sanitary;
‘‘(2) there is a reasonable assurance that
human and veterinary drugs and devices are safe
and effective;
‘‘(3) cosmetics are safe; and
‘‘(4) public health and safety are protected
from electronic product radiation.
The Food and Drug Administration shall promptly and
efficiently review clinical research and take appropriate ac-
tion on the marketing of regulated products in a manner
that does not unduly impede innovation or product avail-
ability. The Food and Drug Administration shall partici-
pate with other countries to reduce the burden of regula-
tion, harmonize regulatory requirements, and achieve ap-
propriate 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, simul-
taneously with the submission each year of the budget for
the Food and Drug Administration, submit to the Com-
mittee 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 poli-
cies to implement such mission;
‘‘(2) review the performance of the Food and
Drug Administration in meeting its own perform-
ance standards, including its own outcome measure-
ments and statutory deadlines for the approval of
products or for other purposes contained in this Act;
‘‘(3) describe the staffing and resources of the
Food and Drug Administration and list those per-
sons and organizations accredited to conduct initial
classification of devices under section 513; and
‘‘(4) describe the goals, activities, and accom-
plishments of the Food and Drug Administration in
bilateral and multinational meetings that addressed
methods and approaches to reduce the burden of
regulation, harmonize regulatory requirements, and
to seek appropriate reciprocal arrangements.
‘‘(f) GAO ANNUAL REPORT.—The Comptroller Gen-
eral of the United States shall each January submit to
the Committee on Commerce of the House of Representa-
tives and the Committee on Labor and Human Resources
of the Senate a report which compares—
‘‘(1) the performance of the Food and Drug
Administration in approving innovative drug, device,
and food products with that of agencies performing
similar functions in countries listed in section
802(b); and
‘‘(2) the resources used by agencies in such
countries to approve such products.
In developing a methodology for the report, the Comptrol-
ler General shall consult with representatives of the Sec-
retary, the regulated industry, academic experts in the
field, and experts knowledgeable about information in such
other countries so that the approach accurately presents
the information in a fair and balanced manner.’’.
SEC. 3. DISPUTE RESOLUTION.
(a) AMENDMENT.—Chapter V is amended by adding
after section 522 the following:
‘‘DISPUTE RESOLUTION
‘‘SEC. 523. In instances in which there is a scientific
controversy between a regulated person and the Secretary
regarding an obligation under this Act and no specific pro-
vision of this Act or regulations promulgated under this
Act by the Secretary provide a right to review of the sub-
ject matter in dispute, the Secretary shall by regulation
establish a procedure under which a regulated person may
request such a review and such a review shall be provided
in a timely manner.’’.
(b) REGULATIONS.—The Secretary of Health and
Human Services shall promulgate regulations implement-
ing section 523 of the Federal Food, Drug, and Cosmetic
Act within 180 days of the date of the enactment of this
Act.
SEC. 4. INVESTIGATIONAL DEVICE EXEMPTIONS.
Section 520(g) (21 U.S.C. 360j(g)) is amended by
adding at the end the following:
‘‘(6) The Secretary shall, by regulation and within
120 days of the date of the enactment of this paragraph,
update the procedures and conditions under which devices
intended for human use may upon application be granted
an exemption from certain requirements of this Act. Such
regulation shall—
‘‘(A) define the parameters for the use of inves-
tigational devices for the benefit of individual pa-
tients, outside of an ongoing investigational protocol
(but subject to the patient protections incorporated
into part 812 or 813 of title 21, Code of Federal
Regulations), during the pendency of a premarket
approval application under section 515 and for uses
intended to demonstrate a reasonable assurance of a
device’s safety or effectiveness in the diagnosis or
treatment of diseases or conditions that are life-
threatening or could be irreversibly debilitating,
when (i) the treating physician determines that the
investigational device likely will provide a benefit, (ii)
the risk of not using the investigational device ex-
ceeds the probable risk of using such device, and (iii)
there is no legally marketed device alternative for
the satisfactory treatment or diagnosis of such dis-
ease or condition;
‘‘(B) ensure that prior to submitting an appli-
cation to the Secretary or to an institutional review
board, any person intending to investigate the safety
or effectiveness of a class III device or an implant
device will have the opportunity to submit an inves-
tigational plan, including a clinical protocol, to the
Secretary for review;
‘‘(C) within 30 days of a request by an appli-
cant for a meeting with the Secretary, require, un-
less the applicant waives this subparagraph, the Sec-
retary to meet with the applicant; and
‘‘(D) permit developmental changes in devices
in response to information gathered during the
course of an investigation without requiring an addi-
tional approval of an application for an investiga-
tional device exemption or the approval of a supple-
ment to such an application, if such changes do not
constitute a significant change in design or a signifi-
cant change in basic principles of operation;
‘‘(E) without additional approval of an applica-
tion for an investigational device exemption, or the
approval of a supplement to such an application,
permit changes or modifications to clinical protocols
that do not affect the validity of data or information
resulting from the completion of an approved proto-
col and do not alter the relationship of likely patient
risk to benefit relied upon to approve a protocol; and
‘‘(F) require a notice to the Secretary within 5
days of implementing any change pursuant to sub-
paragraph (D) or (E).
Any dispute arising from a change under subparagraph
(D) or (E) shall be resolved under section 523(b).’’.
SEC. 5. SPECIAL REVIEW FOR CERTAIN DEVICES.
Section 515(d) (21 U.S.C. 360e(d)) is amended by
adding at the end the following:
‘‘(4) In order to better treat or diagnose life-threaten-
ing or irreversibly debilitating human diseases or condi-
tions, the Secretary shall promulgate a regulation to cre-
ate 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 public health.
Such regulation shall include, among other things, criteria
identifying devices which merit preferential review, speci-
fying procedures for implementing such reviews, and iden-
tifying substantive review criteria appropriate to making
prompt and efficient review of such devices. The Secretary
shall publish in the Federal Register a proposed regulation
to create such review priority no later than 6 months after
the date of the enactment of this paragraph, allowing 60
days for comment. The Secretary will publish a final regu-
lation no later than 120 days after the last day of the
comment period.’’.
SEC. 6. EXPANDING HUMANITARIAN USE OF DEVICES.
(a) SECTION 520(m).—Section 520(m) (21 U.S.C.
360j(m)) is amended—
(1) in paragraph (2), by inserting after and
below subparagraph (C) the following:
‘‘The request shall be in the form of an application to the
Secretary. Within 60 days of the date of the receipt of
an application, the Secretary shall issue an order approv-
ing or denying the application, except that if the Secretary
convenes a scientific advisory panel, the Secretary may
have an additional 60 days in which to issue such order.’’;
(2) by amending paragraph (5) to read as 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
condition for granting such exemption for such device set
forth in paragraphs (2) through (4) no longer is met.’’;
and
(3) by striking paragraph (6).
(b) REGULATIONS.—Any regulation included in title
21 of the Code of Federal Regulations pertaining to hu-
manitarian devices which is inconsistent with the amend-
ments made by subsection (a) shall be deemed rescinded
on the date of the enactment of this Act. The Secretary
shall promulgate regulations pertaining to humanitarian
devices which are consistent with such amendments.
SEC. 7. PERFORMANCE STANDARDS.
(a) SECTION 514.—Section 514 (21 U.S.C. 360d) is
amended to read as follows:
‘‘STANDARDS
‘‘SEC. 514. (a) The Secretary shall, through publica-
tion in the Federal Register, issue notices identifying and
adopting applicable nationally or internationally recog-
nized consensus standards to which a person may self-cer-
tify compliance for the purpose of demonstrating a reason-
able assurance that a device is safe or effective or to deter-
mine compliance with any requirement of this Act. Any
person may elect to utilize data other than those required
by such standards to demonstrate a reasonable assurance
of device safety or effectiveness or compliance with the re-
quirements of this Act.
‘‘(b) The Secretary shall accept certifications that de-
vices conform with each type of standard referenced in
subsection (a) and identified in each such certification to
the extent such standard applies, except that the Secretary
may, at any time, request the person who submitted the
certification to submit the data and information which
such person relied upon in making such certification.’’.
(b) SECTION 301.—Section 301 (21 U.S.C. 331) is
amended by adding after paragraph (w) the following:
‘‘(x) The making of a false or misleading certification
under section 514(b) or the failure or refusal to provide
the information required under section 514(c).’’.
SEC. 8. SCOPE OF REVIEW.
(a) SECTION 513(a).—Section 513(a)(3) (21 U.S.C.
360c(a)(3)) is amended—
(1) in subparagraph (A), by inserting ‘‘one or
more’’ before ‘‘clinical investigations’’;
(2) by adding at the end of subparagraph (A)
the following: ‘‘In determining the type and amount
of data necessary to find a reasonable assurance of
device effectiveness for an approval under section
515, the Secretary shall consider the extent to which
reliance on postmarket controls may contribute to
such assurance and expedite effectiveness determina-
tions without increasing regulatory burdens on per-
sons who submit applications under section 515(c).’’;
(3) by adding at the end the following:
‘‘(C)(i) The Secretary, upon the request of any per-
son intending to submit an application under section 515,
shall meet to determine the type of valid scientific evidence
within the meaning of subparagraphs (A) and (B) that
will be necessary to demonstrate the effectiveness of a de-
vice for the conditions of use proposed by such person to
support an approval of an application. Within 30 days of
such meeting, the Secretary shall identify in writing the
type of valid scientific evidence that will provide a reason-
able assurance that a device is effective under the condi-
tions of use proposed by such person. Any clinical data,
including one or more well-controlled investigations, speci-
fied by the Secretary for demonstrating a reasonable as-
surance of device effectiveness shall reflect the Secretary’s
determination that such data are necessary to establish
device effectiveness and that no other less burdensome
means of evaluating effectiveness are available that would
have a reasonable likelihood of resulting in an approval.
‘‘(ii) The Secretary’s specification of the valid sci-
entific evidence under clause (i) shall be binding upon the
Secretary unless such determination by the Secretary
would be contrary to the public health.’’.
(b) SECTION 513(i).—Section 513(i)(1) (21 U.S.C.
360c(i)(1)) is amended by adding at the end the following:
‘‘(C) To facilitate reviews of reports submitted to the
Secretary under section 510(k), the Secretary shall con-
sider 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 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 re-
quest information accordingly.
‘‘(E) Any determinations of substantial equivalence
by the Secretary shall be based upon the labeling submit-
ted in a report under section 510(k) or labeling agreed
to between the Secretary and persons who submit such
report.
‘‘(F) Representations in promotional materials shall
not require a report under section 510(k) unless such ma-
terials support or promote new intended uses of a legally
marketed device.’’.
(c) SECTION 515(d).—Section 515(d) (21 U.S.C.
360e(d)) is amended—
(1) by adding at the end of paragraph (1)(A)
the following:
‘‘The Secretary’s determination to approve or deny an ap-
plication shall be based on the conditions of use proposed
in labeling. If, based on a fair evaluation of all material
facts, the proposed labeling is neither false or misleading
in any particular, the Secretary shall not consider matters
outside of such labeling in disposing of the application.’’;
and
(2) by adding after paragraph (4), as added by
section 5, the following:
‘‘(5)(A) Supplemental applications shall be required
for any change to a device subject to an approved applica-
tion under this subsection which affects safety or effective-
ness and if a change was made under the requirements
of section 520(f), the holder of the approved application
shall notify the Secretary of such change.
‘‘(B) When reviewing a supplement to an approved
application for an incremental change to the design of a
device that affects safety or effectiveness, the Secretary
shall approve such supplement when nonclinical data dem-
onstrate that a design modification achieves the intended
additional capacity, function, or performance without re-
ducing the safety or effectiveness of the device and, when
appropriate, clinical data in the approved application and
supplements thereto and clinical data specifically evaluat-
ing the design modification provide reasonable assurance
of device effectiveness.
‘‘(6) Representations in promotional materials for de-
vices subject to approved applications under paragraph (1)
shall not be subject to premarket approval under this sec-
tion, unless such representations establish new conditions
of use. Any such representations must be supported by
appropriate substantiation materials in the application
holder’s possession at the time such representations are
made.’’.
SEC. 9. PREMARKET NOTIFICATION.
(a) SECTION 510.—Section 510 (21 U.S.C. 360) is
amended—
(1) in subsection (k), by inserting after ‘‘a de-
vice intended for human use’’ the following: ‘‘(other
than any device classified into class I or II under
section 513 or 520 if such class II device has been
exempted from the requirements of this subsection
under subsection (l))’’;
(2) in subsection (k), by striking ‘‘report to the
Secretary’’ and inserting ‘‘have the option of report-
ing to the Secretary or any person who is not an em-
ployee of the United States and who is accredited
under section 712(a)’’;
(3) by adding after and below paragraph (2) of
subsection (k) the following:
‘‘The accredited person shall review a report made to the
person and submit, not later than 60 days after receiving
the report, to the Secretary the person’s recommendation
for action to be taken by the Secretary on the report.’’;
and
(4) by adding the following after subsection (k):
‘‘(l) Within 30 days after the date of the enactment
of this subsection, the Secretary shall publish in the Fed-
eral 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 ex-
empt from the requirement to file a report under sub-
section (k) as of the date of the publication of the list
in the Federal Register. Beginning on the date that is 1
day after the date of the publication of the list, any person
may petition the Secretary to exempt a type of class II
device from the reporting requirement of subsection (k).
If the Secretary fails to respond to a petition within 120
days of receiving it, the petition shall be deemed to be
granted.’’.
(b) REPORTS UNDER SECTION 510(k).—Class I de-
vices which are intended to be life supporting or life sus-
taining, intended for a use which is of substantial impor-
tance in preventing impairment of human health, or
present a potential unreasonable risk of illness or injury
shall not be excluded from the requirements of reports
under section 510(k) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360(k)).
(c) INITIAL CLASSIFICATION.—Section 513(f) (21
U.S.C. 360c(f)) is amended—
(1) in the second sentence of paragraph (1) by
striking the period at the end and inserting the fol-
lowing: ‘‘unless within 30 days of receiving an order
classifying the device into class III the individual
who submits a report under section 510(k) for such
device requests review with respect to the classifica-
tion of the device and a final order of classification
from the Secretary. After the request, a device clas-
sified into class III under this paragraph shall not
be deemed to be finally classified until the Secretary
has determined the classification of the device based
on the classification criteria set forth in subpara-
graphs (A) through (C) of subsection (a)(1), within
60 days of receiving the request to review and clas-
sify a device. Any device found under this paragraph
not to be substantially equivalent to a device de-
scribed in subparagraph (A)(i) and which is classi-
fied by the Secretary into class III may not be com-
mercially distributed in commerce before it is ap-
proved 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).’’.
(d) SECTION 513(i).—Section 513(i) (21 U.S.C.
360c(i)), as amended by section 8(b), is amended—
(1) in paragraph (1)(A)(ii)(I), by striking ‘‘clin-
ical data’’ and inserting ‘‘appropriate clinical or sci-
entific data’’ and by inserting ‘‘or a person accred-
ited under section 712’’ after ‘‘Secretary’’;
(2) in paragraph (1)(A)(ii)(II), by striking ‘‘ef-
ficacy’’ and inserting ‘‘effectiveness’’; and
(3) by adding at the end of paragraph (1) the
following:
‘‘(G) 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 found substantially equiva-
lent to such device which has not been removed from the
market by an order of the Secretary or a judicial order
because it is unsafe or ineffective.
‘‘(H) For the purpose of determining the intended
use of a predicate device under subparagraph (A), each
use reasonably included within a general use for the predi-
cate device shall be deemed a legally marketed use of the
predicate device and shall be available for use in pre-
market notifications required under section 510(k).’’.
(e) SUNSET.—The amendment made by subsections
(a)(2) and (d)(1) to the extent that they relate to an ac-
credited 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 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) the submission of written information to a
classification panel;
‘‘(ii) the participation of the persons at meet-
ings of the panel; and
‘‘(iii) access to data and information submitted
to a classification panel (except for data and infor-
mation that are not available for public disclosure
under section 552 of title 5, United States Code).
‘‘(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 inter-
ested persons.
‘‘(7) Within 30 days after the date a classification
panel makes its conclusions and recommendations on any
matter under review by the panel, the Food and Drug Ad-
ministration official responsible for the matter shall review
the conclusions and recommendations of the panel, shall
make a final decision on the matter, and shall notify the
affected persons of the decision in writing and, if the deci-
sion differs from the conclusions and recommendations of
the panel, shall include the reasons for the difference.
‘‘(8) A scientific advisory panel under this subsection
shall not be subject to the annual chartering and annual
report requirements of the Federal Advisory Committee
Act. Such a panel shall make an annual report of its ac-
tivities to the Secretary.’’.
SEC. 11. PREMARKET APPROVAL.
Section 515(d) (21 U.S.C. 360e(d)), as amended by
section 8(c)(2), is amended by redesignating paragraphs
(2), (3), (4), (5), and (6) as paragraphs (5), (6), (7), (8),
and (9), respectively, and by adding after paragraph (1)
the following:
‘‘(2) Each application received under subsection (c)
shall be reviewed in a manner to achieve final action on
such application within 180 days of its receipt. The Sec-
retary shall meet with an applicant, at the request of the
applicant, under such an application within 90 days of the
date of the application’s submission.
‘‘(3) On January 1 of each calendar year, the Sec-
retary shall submit to the Committee on Commerce of the
House of Representatives and the Committee on Labor
and Human Resources of the Senate a report summariz-
ing each instance in the previous fiscal year in which the
requirements of paragraph (2) were not met. This report
shall include reasons for the failures to meet the require-
ments of paragraph (2) and proposals to ensure that such
requirements will be met.’’.
SEC. 12. ACCREDITATION FOR ACCREDITED PERSONS.
(a) AMENDMENT.—Subchapter A of chapter VII is
amended by adding at the end the following:
‘‘ACCREDITED PERSONS
‘‘SEC. 712. (a) IN GENERAL.—The Secretary shall,
within 1 year of the date of the enactment of this section,
accredit persons for the purpose of reviewing and initially
classifying devices under section 513(f)(1) that are subject
to a report under section 510(k). An accredited person
may not be used to perform a review of a class III device
or a class II device which is intended to be permanently
implantable or life sustaining or life supporting.
‘‘(b) ACCREDITATION.—
‘‘(1) PROGRAMS.—The Secretary shall provide
for such accreditation through programs adminis-
tered by the Food and Drug Administration, other
government agencies, or by other qualified non-
government organizations.
‘‘(2) ACCREDITATION.—
‘‘(A) GENERAL RULE.—Within 180 days
of the date of the enactment of this section, the
Secretary shall establish and publish in the
Federal Register requirements to accredit or
deny accreditation to persons who request to
perform the duties specified in subsection (a).
The Secretary shall respond to a request for 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
public health.
‘‘(C) PERFORMANCE
AUDITING.—To en-
sure that persons accredited under this section
will continue to meet the standards of accredi-
tation, 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 per-
son 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 de-
vices and which has no organizational, material,
or financial affiliation with such a manufac-
turer, supplier, or vendor.
‘‘(B) Such person shall be a legally con-
stituted entity permitted to conduct the activi-
ties for which it seeks accreditation.
‘‘(C) Such person shall not engage in the
design, manufacture, promotion, or sale of de-
vices.
‘‘(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; and
‘‘(iv) promptly respond and attempt to
resolve complaints regarding its activities
for which it is accredited.
‘‘(4) SELECTION OF ACCREDITED PERSONS.—
The Secretary shall provide each person who chooses
to use an accredited person to receive a section
510(k) report a panel of at least 2 or more accred-
ited persons from which the regulated person may
select 1 for a specific regulatory function.’’.
(b) CONFORMING AMENDMENT.—Section 301 (21
U.S.C. 321), as amended by section 7(b), is amended by
adding at the end the following:
‘‘(y) in the case of a drug, device, or food—
‘‘(A) the submission of a report or rec-
ommendation by a person accredited under section
712 that is false or misleading in any material re-
spect;
‘‘(B) the disclosure by a person accredited
under section 712 of confidential commercial infor-
mation or any trade secret without the express writ-
ten consent of the person who submitted such infor-
mation or secret to such person; or
‘‘(C) the receipt by a person accredited under
section 712 of a bribe in any form or the doing of
any corrupt act by such person associated with a re-
sponsibility 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 per-
son under section 712 of the Federal Food, Drug, and
Cosmetic Act shall be of no force or effect upon the expira-
tion of 7 years from the date of the enactment of this
Act.
(d) REPORT.—Not later than 5 years after the date
of the enactment of this Act, the Secretary of Health and
Human Services shall report to the Committee on Com-
merce of the House of Representatives and the Committee
on Labor and Human Resources of the Senate on the use
of accredited persons under section 712 of the Federal
Food, Drug, and Cosmetic Act, the extent to which such
use was helpful in the implementation of such Act, and
the extent to which such use promoted actions which were
contrary to the purposes of such Act.
SEC. 13. PREAMENDMENT DEVICES.
Section 515(i) (21 U.S.C. 360e(i)) is amended to
read as follows:
‘‘REVISION
‘‘(i) Within 6 months of the date of the enactment
of the Medical Device Regulatory Modernization Act of
1997, the Secretary shall publish in the Federal Register
a list of the types of devices classified into class III under
section 513(d), which are not subject to a regulation under
section 515(B), and for which the Secretary has deter-
mined that premarket approval is unnecessary to protect
the public health. Each such type of device listed in the
Federal Register publication shall be regulated as a class
‘‘(1) an implantable device, or
‘‘(2) a life-sustaining or life-supporting device
used outside a device user facility.
‘‘(b) SURVEILLANCE APPROVAL.—Each manufac-
turer 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 ap-
proval of the Secretary, a plan for the required surveil-
lance. 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 experi-
ence to undertake such surveillance and if such plan will
result in information necessary to determine the occur-
rence of unforeseen events. Any order requiring a prospec-
tive postmarket surveillance shall not require a surveil-
lance period greater than 18 months unless the Secretary
for public health concerns extends the period for an addi-
tional 18 months.’’.
SEC. 16. HARMONIZATION.
(a) SECTION
520(f).—Section 520(f)(1)(B) (21
U.S.C. 360j(f)(1)(B)) is amended by striking ‘‘and’’ at the
end of clause (i), by striking the period at the end of
clause (ii) and inserting ‘‘; and’’ and by adding after
clause (ii) the following:
‘‘(iii) ensure that such regulation conforms, to
the extent practicable, with the international stand-
ards organization standards defining quality sys-
tems, or parts thereof, for medical devices.’’.
(b) SECTION 803.—Section 803 (21 U.S.C. 383) is
amended by adding at the end the following:
‘‘(c)(1) The Secretary shall participate in meetings
with other countries to discuss methods and approaches
to reduce the burden of regulation, harmonize regulatory
requirements, and seek appropriate reciprocal arrange-
ments. The Secretary shall, within 180 days of the date
of enactment of this subsection, make public a plan that
establishes a framework for achieving mutual recognition
of good manufacturing practices.
‘‘(2) The Secretary shall report to the Committee on
Commerce of the House of Representatives and the Com-
mittee on Labor and Human Resources of the Senate at
least 60 days before executing any bilateral or multilateral
agreement under paragraph (1).’’.
SEC. 17. REPORTS.
(a) EXCLUSION OF REPORTS BY DISTRIBUTORS.—
Section 519 (21 U.S.C. 360i) is amended—
(1) in subsection (a), by striking ‘‘manufac-
turer, importer, or distributor’’ and inserting ‘‘man-
ufacturer or importer’’;
(2) in paragraph (4) of subsection (a), by strik-
ing ‘‘manufacturer, importer, or distributor’’ and in-
serting ‘‘manufacturer or importer’’;
(3) in paragraph (8) of subsection (a), by strik-
ing ‘‘manufacturer, importer, or distributor’’ each
place it occurs and inserting ‘‘manufacturer or im-
porter’’;
(4) in subsection (a), by inserting ‘‘and’’ at the
end of paragraph (7), by striking ‘‘; and’’ at the end
of paragraph (8) and inserting a period, and by
striking paragraph (9).
(b) REGULATIONS.—Within 120 days after the date
of enactment of this section, the Secretary of Health and
Human Services shall delete the regulations of the Sec-
retary appearing in part 804 of title 21 of the Code of
Federal Regulations, requiring distributors, other than
importers, to make reports of deaths, serious injuries or
illness, and malfunctions related to devices.
(c) CERTIFICATIONS, AND REPORTS OF REMOVALS
AND CORRECTIONS.—Section 519 (21 U.S.C. 360i) is
amended by striking subsections (d) and (f).
(d) DESIGNATED DEVICE USER FACILITIES.—Sec-
tion 519(b) (21 U.S.C. 360i(b)) is amended—
(1) by redesignating paragraphs (2) through
(5) as paragraphs (3) through (6), respectively;
(2) by striking ‘‘(b)(1)(A) Whenever a device
user facility receives’’ and inserting the following:
‘‘(b)(1) One year after the date of the enactment of the
Medical Device Regulatory Modernization Act of 1997,
regulations included in title 21, Code of Federal Regula-
tions, pertaining to user reporting shall be deemed to be
rescinded by the Secretary. On and after such date, there
shall be no obligations for any device user facility to com-
ply with this subsection until the Secretary promulgates
regulations which limit user reporting to a subset of hos-
pitals and nursing homes to create a representative profile
of user reports for device deaths and serious illnesses or
serious injuries.
‘‘(2)(A) Whenever a designated device user facility re-
ceives’’;
(3) in paragraph (2) (as designated by para-
graph (2) of this subsection)—
(A) in subparagraph (B), in the matter
preceding clause (i), by inserting ‘‘designated’’
before ‘‘device user facility’’;
(B) in subparagraph (C)—
(i) in the first sentence—
(I) by inserting ‘‘designated’’ be-
fore ‘‘device user facility’’; and
(II) by striking ‘‘a semi-annual
basis’’ and inserting ‘‘an annual
basis’’;
(ii) in the second sentence, by striking
‘‘and July 1’’; and
(iii) by striking the matter after and
below clause (iv); and
(C) in subparagraph (D), by inserting
‘‘designated’’ before ‘‘device user facility’’;
(4) in each of paragraphs (3) through (5) (as
redesignated by paragraph (1) of this subsection), by
striking ‘‘paragraph (1)’’ each place such term ap-
pears and inserting ‘‘paragraph (2)’’; and
(5) in paragraph (6) (as redesignated by para-
graph (1) of this subsection)—
(A) by redesignating subparagraph (B) as
subparagraph (C); and
(B) by inserting after subparagraph (A)
the following:
‘‘(B) The term ‘designated device user facility’
means a hospital or a nursing home that is des-
ignated as a member of the subset established by the
Secretary for purposes of paragraph (1).’’.
SEC. 18. G.M.P. AND DEVICE REPORTS.
Section 303(c) (21 U.S.C 333(c)) is amended by in-
serting before the period at the end the following: ‘‘; or
(6) for having violated subsection (a), (b), (c), or (k) of
section 301 by failure to comply with either section
502(t)(2) or 501(h), or for having violated section
301(q)(1)(B) by failing to furnish material or information
required under section 519(a), if such person acted in
good faith, had no reason to believe that the person’s acts
violated the law, and had no prior notice from the Sec-
retary that the acts constituted violations of the Act’’.
SEC. 19. INFORMATION SYSTEM.
Chapter IX is amended by adding at the end the fol-
lowing:
‘‘SEC. 906. INFORMATION SYSTEM.
‘‘The Secretary shall establish and maintain an infor-
mation system to track the status and progress of each
application or submission (including a petition, notifica-
tion, or other similar form of request) submitted to the
Food and Drug Administration requesting agency action.
The system shall permit access by the applicant.’’.
SEC. 20. ENVIRONMENTAL IMPACT REVIEW.
Chapter VII is amended by adding at the end the
following: