mined that the application appears to be in a form
that would receive approval within 180 days of re-
ceipt of such application. The applicant may waive
such meeting and instead receive in writing from the
Secretary such information within 30 days of the
panel review.
‘‘(F) The Secretary shall meet with the appli-
cant not later than 15 days after the panel review
if the Secretary has determined that the application
is not in a form that would require approval under
paragraph (1)(A). Prior to the meeting, the Sec-
retary shall in writing present to the applicant each
basis for denying approval of the application and the
additional information necessary to bring the appli-
cation into a form that would require an approval.
‘‘(G) When the Secretary reviews an application
and a classification panel review and recommenda-
tion is not required under subsection (c)(2), the Sec-
retary shall meet with the applicant no later than
135 days after receipt of an application which has
been accepted for filing under subsection (c)(1) and
inform the applicant whether or not the application
is in a form that would require approval under para-
graph (1)(A). If the application is in such form, the
Secretary shall, at or prior to the meeting, present
in writing a description of all additional information
necessary to require an approval of an application
under paragraph (1)(A). If the application is not in
such form, the Secretary shall, prior to the meeting,
present in writing to the applicant each basis for de-
nying approval of the application and the additional
information necessary to bring the application into
a form that would require approval.
‘‘(H) When an application is reviewed by an ac-
credited person and a classification panel is not re-
quired under subsection (c)(2) to review a premarket
approval application, the accredited person shall, no
later than 120 days after filing, or at such other
designated time determined by the applicant and the
accredited person, provide the Secretary with a re-
port and recommendation.
‘‘(I) The Secretary shall approve or deny an ap-
plication reviewed by an accredited person within
180 days of receipt of an application which has been
accepted for filing under paragraph (1) unless the
accredited person submits its report and rec-
ommendation to the Secretary later than 150 days
after such receipt. If the report and recommendation
of an accredited person is submitted to the Secretary
later than 150 days after receipt of an application
which has been accepted for filing under paragraph
(1), the Secretary shall have 30 days from the date
of receipt to approve or deny the application.
‘‘(3)(A) The time for the Secretary’s review of an ap-
plication under this subsection shall not be enlarged by
any amendment to the application and shall take no more
than 180 days.
‘‘(B) The Secretary shall ensure that each time frame
under paragraph (2) is met. For each instance in which
a review requirement under paragraph (2) is not met, a
report to the Commissioner and the Secretary is required
no later than 10 days after the date of the scheduled event
set forth in paragraph (2) fully explaining the reason that
the scheduled time frame was not met. Within 10 days
after receipt of such report, the Commissioner shall pro-
vide an explanation to the applicant regarding the failure
to comply with paragraph (2) and set the date for satisfy-
ing the scheduled review program obligation.
‘‘(C) On January 1 of each calendar year, the Sec-
retary shall submit to the committees of Congress with
substantive oversight responsibility for the Food and Drug
Administration a report summarizing each instance in the
previous fiscal year in which the requirements of para-
graph (2) were not met. This report shall include reasons
for the failures to meet the requirements of paragraph (2)
and proposals to ensure that such requirements will be
met.’’.
(c) REGULATIONS.—The Secretary of Health and
Human Services shall revise, through notice and comment
procedures, the regulations appearing in part 814 of title
21 of the Code of Federal Regulations to conform to this
section’s amendment of section 515 of the Federal Food,
Drug, and Cosmetic Act and to eliminate premarket ap-
proval of supplements which relate to manufacturing
changes and other changes which do not actually affect
device safety or effectiveness. The Secretary shall publish
in the Federal Register such proposed regulation no later
than 6 months after the date of the enactment of this Act,
allowing 60 days for comment. The Secretary shall publish
a final regulation no later than 60 days after the last day
for the comment period.
SEC. 12. ACCREDITATION OF THIRD PARTIES.
(a) AMENDMENT.—Subchapter A of chapter VII is
amended by adding at the end the following:
‘‘ACCREDITED PERSONS
‘‘(a) SEC. 712. IN GENERAL.—The Secretary shall,
within 180 days of the date of the enactment of this sec-
tion, by regulation establish procedures for the accredita-
tion of third parties for the purposes of—
‘‘(1) reviewing applications under section 515,
providing written reviews to the Secretary for the
Secretary’s consideration, and making recommenda-
tions on whether or not such applications should be
approved; and
‘‘(2) conducting good manufacturing practice
inspections to determine the conformance of a facil-
ity with regulations promulgated under section
520(f).
‘‘(b) ACCREDITATION.—
‘‘(1) PROGRAMS.—The Secretary shall provide
for such accreditation through programs adminis-
tered by government agencies or by other qualified
organizations.
‘‘(2) IMPLEMENTATION.—The Secretary may
designate one or more qualified non-government or-
ganizations to implement such programs. Such orga-
nizations shall implement such programs from fees
charged to applicants for accreditation.
‘‘(3) QUALIFICATIONS.—An accredited person
shall meet the following requirements:
‘‘(A) Such person shall be an independent
organization which is not owned or controlled
by manufacturer, supplier, or vendor of devices
and which has no organizational, material, or
financial affiliation with such a manufacturer,
supplier, or vendor.
‘‘(B) Such person shall be a legally 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.’’.
(b) CONFORMING AMENDMENT.—Section 301 (21
U.S.C. 321) is amended by redesignating the second para-
graph (u) as paragraph (v) and by adding after that para-
graph the following:
‘‘(w) 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.’’.
SEC. 13. RECLASSIFICATION OF PREAMENDMENT DEVICES.
Section 515 (21 U.S.C. 360e) is amended by adding
at the end the following:
‘‘(j) The Secretary shall, within 18 months of the
date of enactment of this subsection, publish in the Fed-
eral Register a proposed regulation reclassifying all de-
vices identified in subsection (i)(2) into class II except a
device for which the Secretary has already published a
proposed regulation required under subsection (i)(2). The
Secretary shall provide 60 days for comment on such pro-
posed regulation required by this subsection and shall pub-
lish a final regulation in the Federal Register within 60
days after the last day for comment reclassifying into class
II each such device not included in a proposed regulation
required under subsection (i)(2) or maintaining, where ap-
propriate, the original classification of such device.’’.
SEC. 14. DEVICE TRACKING.
Subsection (e) of section 519 (21 U.S.C. 360i) is
amended to read as follows:
‘‘(e) DEVICE TRACKING.—The Secretary may by
order require a manufacturer to adopt a method of track-
ing a class II or class III device—
‘‘(1) the failure of which would be life threaten-
ing or have permanently debilitating effects; and
‘‘(2) which is—
‘‘(A) a permanently 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 first intro-
duced or delivered for introduction into interstate com-
merce after January 1, 1991, which is a class II or class
III device the failure of which would be reasonably likely
to have serious adverse health consequences and which
is—
‘‘(1) a permanently implantable device, or
‘‘(2) a life-sustaining or life-supporting device
used outside a device user facility.
‘‘(b) SURVEILLANCE APPROVAL.—Each manufac-
turer required to conduct a surveillance of a device shall,
within 30 days of receiving notice from the Secretary that
the manufacturer is required under this section to conduct
such surveillance, submit, for the approval of the Sec-
retary, a proposal for the required surveillance. The Sec-
retary, within 60 days of the receipt of such proposal, shall
determine if the person designated to conduct the surveil-
lance has appropriate qualifications and experience to un-
dertake such surveillance and if such proposal will result
in information necessary to determine the occurrence of
unforeseen events. Any order requiring a prospective
postmarket surveillance shall not require a surveillance pe-
riod greater than 18 months.’’.
SEC. 16. HARMONIZATION.
(a) SECTION
520(f).—Section 520(f)(1)(B) (21
U.S.C. 360j(f)(1)(B)) is amended by striking ‘‘and’’ at the
end of clause (i), by striking the period at the end of
clause (ii) and inserting ‘‘; and’’ and by adding after
clause (ii) the following:
‘‘(iii) ensure that such regulation conforms, to
the extent practicable, with the international 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 regularly and continu-
ously participate in meetings with other countries to dis-
cuss methods and approaches to reduce the burden of reg-
ulation, harmonize regulatory requirements, and seek ap-
propriate reciprocal arrangements. The Secretary shall,
within 180 days of the date of enactment of this sub-
section, 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. GOOD MANUFACTURING PRACTICE INSPECTIONS.
(a) Section 704 (21 U.S.C. 374) is amended—
(1) in subsection (a)(1), by inserting ‘‘, or an
accredited person to conduct good manufacturing
practice inspections under section 712’’ after ‘‘Sec-
retary’’;
(2) in subsection (a)(3), by inserting ‘‘, or an
accredited organization or individual under section
712,’’ after ‘‘employee’’;
(3) in subsection (b), by inserting ‘‘, or an ac-
credited person under section 712,’’ after ‘‘em-
ployee’’;
(4) in subsection (b), by inserting ‘‘(1)’’ after
‘‘(b)’’, by redesignating clauses (1) and (2) as
clauses (A) and (B), respectively, and by adding at
the end the following:
‘‘(2) The Secretary shall provide, at least 10 days
from the date of presentation of the report of conditions
or practices identified in paragraph (1), for the person re-
ceiving such report to respond. The Secretary shall take
no regulatory action against a person or article identified
in such a report until completing a review of such response
which is timely submitted to the Secretary, except the Sec-
retary may take immediate action when the Secretary
finds that there is a reasonable probability that a device
intended for human use would cause serious, adverse
health consequences or death or that any regulated article
could present an unreasonable and substantial risk of in-
jury or illness to the public health. The Secretary shall
provide to the regulated person, within 30 days of receiv-
ing a response to the report identified in paragraph (1),
a written detailed assessment of the response.
‘‘(3) At the time an accredited person completes an
inspection under the authority of this section and section
712, such person shall identify in writing to the person
subject to the inspection each condition or practice ob-
served during such inspection which suggests a deviation
from requirements of this Act. However, such accredited
person shall immediately submit to the Secretary the find-
ings of the inspection when the device to which such find-
ings relate is intended for human use and presents a rea-
sonable probability that such device would cause serious,
adverse health consequences or death or that such device
could present an unreasonable and substantial risk of in-
jury or illness to the public unless the person subject to
the inspection—
‘‘(A) immediately ceases distribution of the de-
vice;
‘‘(B) immediately notifies health professionals
and device user facilities to instruct such profes-
sionals and facilities to cease use of the device; and