I
105TH CONGRESS
1ST SESSION
H. R. 1093
To amend the medical device provisions of the Federal Food, Drug, and
Cosmetic Act.
IN THE HOUSE OF REPRESENTATIVES
MARCH 18, 1997
Mr. FOX of Pennsylvania introduced the following bill; which was referred to
the Committee on Commerce
A BILL
To amend the medical device provisions of the Federal Food,
Drug, and Cosmetic Act.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE AND REFERENCE.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Life Extending and Life Saving Device Act of 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 a section or other provi-
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sion of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 201 et seq.).
SEC. 2. DEFINITIONS.
Section 201 (21 U.S.C. 321) is amended—
(1) in paragraph (h), by striking ‘‘reagent’’ and
inserting ‘‘in vitro diagnostic test system, special
purpose reagent,’’, and
(2) by adding at the end the following:
‘‘(gg) The term ‘special purpose reagent’ means any
monoclonal or polyclonal antibody, antigen, genetic probe,
or other similar or related article that is a component of
an in vitro diagnostic test system.
‘‘(hh) The term ‘in vitro diagnostic test system’
means a system intended for use in the diagnosis of dis-
ease or other conditions, including a determination of the
state of health, in order to cure, mitigate, treat, or prevent
disease or its sequelae.’’.
SEC. 3. MISSION OF THE FOOD AND DRUG ADMINISTRA-
TION.
Section 903 (21 U.S.C. 393) is amended by adding
at the end the following:
‘‘(d) The mission of the Food and Drug Administra-
tion (with respect to drugs, biological products, and de-
vices) is to promote and protect the health of the American
people. This mission should be achieved by—
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‘‘(1) facilitating the timely availability of safe
and effective products that benefit the American
public,
‘‘(2) encouraging the efficient development of
new products in the United States,
‘‘(3) taking prompt and appropriate action
where postmarketing surveillance demonstrated that
products present a health risk to the American pub-
lic,
‘‘(4) ensuring that human drugs, biological
products, and devices are tested and manufactured
consistent with the goal of harmonization of inter-
national standards,
‘‘(5) facilitating the flow of information to edu-
cate health professionals and the American public,
and
‘‘(6) enforcing the applicable statutes and regu-
lations in a timely, fair, and decisive manner.’’.
SEC. 4. HARMONIZATION.
Section 803 (21 U.S.C. 383) is amended by adding
at the end the following:
‘‘(c)(1) The Secretary shall take such action as may
be appropriate to harmonize the requirements of this Act
for good manufacturing practice regulations with require-
ments of similar laws in foreign countries through the
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International Conference on Harmonization by December
1996.
‘‘(2) The Secretary shall regularly participate in
meetings with other foreign governments to discuss meth-
ods and approaches to harmonize international regulatory
requirements. The office shall forward any proposed
agreements resulting from such meetings to the appro-
priate officials in each participating country for consider-
ation in the formulation of agreements to harmonize inter-
national regulatory requirements. The office shall have the
responsibility of ensuring that the process of harmonizing
international regulatory requirements for devices and
drugs is continuous.
‘‘(3) The Commissioner shall initially report to com-
mittees of the United States Congress with oversight re-
sponsibilities for the United States Food and Drug Ad-
ministration regarding the efforts and accomplishments of
the office no later than 18 months after the date of enact-
ment of this paragraph. Thereafter, the Commissioner
shall report to such committees biennially.’’.
SEC. 5. PREMARKET NOTIFICATION.
(a) Section 510 (21 U.S.C. 360) is amended—
(1) in subsection (k), by inserting ‘‘excluding
any device classified into class I under section 513
or 520, or any device classified into class II under
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section 513 or 520, if such class II device has been
exempted from the requirements of this subsection
under paragraph (1),’’ after ‘‘a device intended for
human use’’,
(2) in subsection (k), by striking ‘‘report’’ and
inserting ‘‘have the option of reporting’’,
(3) in subsection (k), by striking ‘‘or any per-
son who is not an employee of the United States,
and who is accredited by the Secretary or the Sec-
retary’s designee to receive and review notifications
required under this subsection and to make rec-
ommendations under subsection 513(f)(1) about
such notifications’’ after ‘‘report to the Secretary’’,
and
(4) by inserting after subsection (k) the follow-
ing:
‘‘(l) Within 3 months after the date of the enactment
of this subsection, the Secretary shall publish a notice in
the Federal Register soliciting from the public the identi-
fication of class II devices that should not be subject to
the notification requirements of subsection (k) because
such notification is unnecessary to ensure public health.
The notice shall provide no more than 30 days for submis-
sion of information to the Secretary, and the Secretary
shall by regulation exempt specified class II devices from
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notification under subsection (k). The proposal for such
a regulation shall permit 30 days for comment. The Sec-
retary shall publish a final regulation in the Federal Reg-
ister no later than 45 days after the end of the comment
period. If the Secretary fails to promulgate a final regula-
tion 45 days after the end of the comment period, each
class II device proposed for exemption from subsection (k)
shall be deemed to be exempt from that subsection.
‘‘(m) The Secretary may not withhold a determina-
tion of the initial classification of a device under section
513(f)(1) for any reason, including that the facility in
which a device may be manufactured is not in compliance
with good manufacturing practice requirements set forth
in regulations promulgated under the authority of section
520(f).’’.
(b) NOTICE.—Section 513(f) (21 U.S.C. 360c(f)) is
amended by redesignating paragraphs (2) and (3) as para-
graphs (3) and (4), respectively, and by inserting after
paragraph (1) the following:
‘‘(2)(A) If the Secretary fails to make a determina-
tion under paragraph (1)(A) within 90 days of receipt of
a notification required by subsection (k), the Secretary
shall send a letter by registered mail to the submitter of
such notification stating that additional time is necessary
to determine the initial classification of the device. Addi-
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tionally, such letter shall state each reason necessitating
the need for additional time and provide the submitter a
date for completion.
‘‘(B) Within 90 days of receiving a notification re-
quired under subsection (k) for devices identified as being
substantially equivalent to a class II device, a person ac-
credited to conduct reviews of such notifications shall
make a determination of initial classification under para-
graph (1)(A) of any such device which was not introduced
or delivered for introduction into interstate commerce for
commercial distribution before the date of enactment of
this section. Such determination of initial classification
shall be final. The accredited person shall immediately, by
registered mail, provide to the submitter of such notifica-
tion an order classifying the device. If the accredited per-
son determines that the device should be classified into
class III, such person shall refer the premarket notifica-
tion submission to the Secretary. The Secretary shall have
30 days to review the submission and issue an order ini-
tially classifying the device. If the Secretary fails to make
a classification decision within 30 days, the Secretary shall
send a letter to the submitter of the notification which
conforms to the requirements of subparagraph (A).
‘‘(C) Within 60 days of receiving a notification re-
quired under subsection (k) for a device identified as being
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substantially equivalent to a class III device, a person ac-
credited to conduct reviews of such notification shall make
a determination of the initial classification under para-
graph (1)(A) of any such device which was not introduced
or delivered for introduction into interstate commerce for
commercial distribution before the date of enactment of
this section, and within such time period submit a rec-
ommendation to the Secretary and to the submitter of the
premarket notification which contains such determination.
The recommendation by such person of initial classifica-
tion of a device shall be binding upon the Secretary, unless
the Secretary within 30 calendar days of receipt of the
recommendation finds that the recommendation is clearly
erroneous, issues an order under this subsection initially
classifying the device and provides, as part of the order,
a detailed explanation of the basis for the finding that the
classification recommendation of the accredited person is
clearly erroneous. If within 90 days from the date of re-
ceipt of the notification the Secretary does not issue an
order that differs from the recommendation of the accred-
ited person, the Secretary shall promptly send by reg-
istered mail to the submitter of the notification such rec-
ommendation as the Secretary’s order of initial classifica-
tion. If the Secretary does not provide the submitter such
notification by registered mail as specified herein, the rec-
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ommendation of classification provided to the submitter
of the premarket notification shall become the Secretary’s
order of initial classification of the device. Such classifica-
tion may only be charged pursuant to the procedures spec-
ified in paragraph (3) of this subsection.
‘‘(D) Any change or modification to a device initially
classified under this subsection, other than a major change
(including any major modification) in the intended use,
shall not require an additional submission under sub-
section (k) if such change or modification is supported by
appropriate data or information, and the change or modi-
fication can be shown to not adversely affect the safety
or effectiveness of the device which was initially classified
under this subsection. All data or information relied upon
to document that a change to (including any modification
of) such device does not require an additional notification
under subsection (k) shall be made a part of the good
manufacturing practice document file required by regula-
tions promulgated under section 520(f) and shall be main-
tained for a period of time equal to the commercial life
of the device, at a minimum.’’.
(c) Section 513(i)(1) (21 U.S.C. 360c(i)(1)) is
amended by adding after subparagraph (B) the following:
‘‘(C) For the purpose of determining the intended use
of a predicate device under subparagraph (A), each use
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reasonably included within a general use for the predicate
device shall be deemed a legally marketed use of the predi-
cate device and shall be available in premarket notifica-
tions required under subsection (k).
‘‘(D) For the purpose of determining substantial
equivalence, the Secretary shall not consider any uses or
indications of a device that are not specifically identified
in a premarket market notification submission under sub-
section (k).’’.
SEC. 6. THE RISK/BENEFIT DETERMINATION.
Section 513(a)(2)(A) is amended by striking the
comma following the word ‘‘intended’’ and adding to the
end of the paragraph the following: ‘‘by the person legally
responsible for labeling the device,’’.
SEC. 7. EFFECTIVENESS DETERMINATION.
(a) Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A))
is amended by adding at the end the following: ‘‘Well-con-
trolled clinical investigations shall not be appropriate, un-
less the Secretary determines, after consultation with an
advisory committee constituted under subsection (b) that
such investigations are necessary to demonstrate that the
device will have the effect it purports or is represented
to have under the conditions of use prescribed, rec-
ommended, or suggested in the labeling of the device. Any
person may submit well-controlled clinical investigations
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‘‘(iv) The evaluation of any indication for use
not included in the labeling of a device, unless the
person legally responsible for the labeling of the de-
vice promotes such indications for use.’’.
SEC. 8. PREMARKET APPROVAL.
(a) Section 515(c)(1) (21 U.S.C. 360e(c)(1)) is
amended by inserting ‘‘, or may file such application with
a person or organization authorized to review applications
for premarket approval’’ after ‘‘class III device’’ and by
redesignating paragraph (2) as paragraph (4) and by add-
ing after paragraph (1) the following:
‘‘(2)(A) Persons or organizations authorized to re-
ceive and review applications for approval of class III de-
vices shall review such applications in accordance with the
schedule of events identified in subsection (d)(2), unless
such organization or person by contract with an applicant
alters the schedule of events or eliminates any such event
other than the requirements to file an application before
undertaking a substantive review, refer an application
under subparagraph (C) to an advisory committee con-
stituted under the authority of section 513(b), and com-
plete the review of an application in a timely manner.
‘‘(B) The review standard for a premarket approval
application applicable to such persons or organizations
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‘‘(3) The Secretary may use experts qualified by
training and experience in addition to employees of the
United States Government to review applications. Reviews
by such experts may relate to portions of an application
or entire applications. Each such review shall be in writing
and submitted to the Secretary for consideration of wheth-
er to approve a device for commercial distribution.’’.
(b) Section 515(c) (21 U.S.C. 360e(c)), as amended
by subsection (a), is amended by adding the following at
the end of paragraph (4): ‘‘Such panel shall be scheduled
to meet at least 4 times each calendar year to consider
among other things the approval of applications submitted
to the Secretary under this subsection. Such meetings
shall, to the extent possible, be scheduled at equal inter-
vals throughout the year.’’.
(c) Section 515(d) (21 U.S.C. 360e(d)) is amended
by redesignating paragraphs (2) and (3) as paragraphs
(5) and (6), respectively, and by inserting after paragraph
(1) the following:
‘‘(2) Each application received under subsection (c)
shall be reviewed in the following manner to achieve final
action on such applications within 180 days of their re-
ceipt:
‘‘(A) The Secretary shall make a determination
within 30 days of receipt of an application submitted
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under subsection (c) of whether the application sat-
isfies the content requirements of subsection (c)(1)
and applicable regulations.
‘‘(B) The Secretary shall meet with an appli-
cant within 90 days of receipt of an application that
has been accepted for filing to discuss the review
status of the application. If the application does not
appear in a form that would necessitate an approval
under this subsection, the Secretary shall, in writing
and prior to the meeting, present to the applicant a
description of any deficiencies with the application
and what information would be necessary to bring
the application into a form that would require an
approval.
‘‘(C) The Secretary shall provide an applicant
the opportunity for a meeting 115 days after receipt
of an application which has been accepted for filing
under subsection (c) to inform the applicant of the
status of the application, advise the applicant of any
deficiencies in the application not previously commu-
nicated to the applicant, review proposed labeling for
the device, and review the actions taken to correct
deficiencies identified at the meeting held on the
90th day after receipt of the filed application.
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‘‘(D) The Secretary shall refer an application to
a panel established under section 513 for review and
for an approval recommendation, unless a panel is
not required under subsection (c)(2), within 30 days
of the meeting referenced in subparagraph (B) or at
the next scheduled panel meeting following such
meeting, whichever is later.
‘‘(E) The Secretary shall meet with the appli-
cant within 30 days of the panel review if the Sec-
retary has determined that the application is not in
a form that would require approval under this sub-
section. Prior to the meeting, the Secretary shall, in
writing, present to the applicant each basis for deny-
ing approval of the application and the additional in-
formation necessary to bring the application into a
form that could be approved.
‘‘(F) The Secretary shall meet within 10 days
of the panel review to present to an applicant a de-
scription of all additional information necessary to
require an approval of an application under this sub-
section if the Secretary has determined that the ap-
plication appears to be in a form that would receive
approval within 180 days of receipt of such applica-
tion. The applicant may waive such meeting and in-
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stead receive in writing from the Secretary, within
30 days of the panel review, such information.
‘‘(G) The Secretary shall meet with the appli-
cant no later than 150 days after receipt of an ap-
plication which has been accepted for filing under
subsection (c), if an advisory panel is not required
under subsection (c)(2), and inform the applicant
whether or not the application is in a form that
could be approved under this subsection. If the ap-
plication is in such form, the Secretary shall, at or
prior to the meeting, present in writing a description
of all additional information necessary to require an
approval of an application under this subsection. If
the application is not in such form, the Secretary
shall, prior to the meeting, present in writing to the
applicant each basis for denying the approval of the
application and the additional information necessary
to bring the application into a form that could be
approved.
‘‘(H) The Secretary shall issue an order either
approving or denying an application within 180 days
of receipt of an application that has been accepted
for filing.
‘‘(3)(A) The time for the Secretary’s review of an ap-
plication under this subsection shall not be enlarged by
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any amendment to the application and shall take no more
than 180 days.
‘‘(B) The Secretary shall ensure that each time frame
under paragraph (2) is met. For each instance in which
a review requirement under paragraph (2) is not met, a
report to the Secretary is required no later than 10 days
after the date of the scheduled event set forth in para-
graph (2) fully explaining the reason that the scheduled
time frame was not met. Within 10 days after receipt of
such report, the Secretary shall provide an explanation to
the applicant regarding the failure to comply with para-
graph (2) and set the date for satisfying 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.
‘‘(4) In order to better treat or diagnose life-threaten-
ing or irreversibly debilitating diseases or conditions of
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man, the Secretary shall promulgate regulations to create
review priority for devices—
‘‘(A) representing breakthrough technologies;
‘‘(B) for which no approved alternatives exist;
‘‘(C) which offer significant advantages over ex-
isting approved alternatives; or
‘‘(D) the availability of which is in the best in-
terest of the public health.
Such regulations shall include criteria for identifying de-
vices which merit preferential review and shall specify pro-
cedures for implementing such reviews. The Secretary
shall publish in the Federal Register a proposed regulation
no later than 6 months after the date of enactment of the
paragraph, allowing 60 days for comment. The Secretary
shall publish a final regulation no later than 60 days after
the last day of the comment period.’’.
(d) Section 515(d) (21 U.S.C. 360e(d)) is amended
by adding before the semicolon at the end of paragraph
(5)(B) the following: ‘‘(the determination of a reasonable
assurance that a device is effective under the conditions
of use prescribed, recommended, or suggested in proposed
labeling shall not include uses or indications for use not
identified in the application)’’.
(e) The Secretary of Health and Human Services
shall revise, through notice and comment procedures, the
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regulations appearing in title 21 of the Code of Federal
Regulations, part 814, to conform the regulations to the
amendments of section 515 of the Federal Food, Drug,
and Cosmetic Act made by this section and to eliminate
premarket approval of supplements which relate to manu-
facturing changes and other changes which do not actually
affect device safety or effectiveness.
SEC. 9. INVESTIGATIONAL DEVICE EXEMPTIONS.
Section 520(g) (21 U.S.C. 360j(g)) is amended by
adding at the end the following:
‘‘(6) The Secretary of Health and Human Services
shall, within 120 days of the date of enactment of this
paragraph, by regulation amending the content of parts
812 and 813 of title 21 of the Code of Federal Regula-
tions, update the procedures and conditions under which
devices intended for human use may upon application be
granted an exemption from certain requirements under
the Act. Such regulation shall—
‘‘(A) permit the use of investigational devices,
outside of the investigational protocol, in the diag-
nosis or treatment of diseases or conditions that are
life threatening or could be irreversibly debilitating,
when the risk of not using the investigational device
exceeds the probable risk of using such device as de-
termined by the local institutional review board;
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‘‘(B) require that prior to submitting an appli-
cation to the Secretary, any person intending to in-
vestigate the safety or effectiveness of a class III de-
vice or an implant may submit an investigational
plan, including clinical protocol, to the Secretary for
review; and
‘‘(C) provide a submitter who disputes the Sec-
retary’s response under subparagraph (B) a right to
appear before an advisory committee of the inves-
tigational plan and the Secretary’s evaluation of
such plan.
Within 30 days of receipt of an investigational plan under
subparagraph (B), the Secretary shall respond in writing
to the submitter identifying each deficiency with the plan
and such other information that will facilitate the review
and approval of an application.’’.
SEC. 10. CLASSIFICATION AND RECLASSIFICATION OF IN
VITRO DIAGNOSTIC TEST SYSTEMS.
(a) Section 513 (21 U.S.C. 360c) is amended by add-
ing at the end the following:
‘‘INITIAL CLASSIFICATION AND RECLASSIFICATION OF IN
VITRO DIAGNOSTIC TEST SYSTEMS
‘‘(j) Any class III in vitro diagnostic test system in-
tended for human use which was introduced or delivered
for introduction into interstate commerce for commercial
distribution before the date of enactment of this para-
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graph is deemed to be automatically reclassified by the
Secretary in class II on the date 1 year after the date
of enactment of this subsection unless the Secretary, by
regulation, finds that classification of the device in class
III is necessary to provide reasonable assurance of its
safety and effectiveness. Any such device that the Sec-
retary classifies in class III shall remain in class III for
3 years after the effective date of the regulation classifying
the device in class III. At the end of the 3-year period,
the device is deemed to be automatically reclassified by
the Secretary in class II unless the Secretary, by notice
and comment rulemaking, extends the class III designa-
tion for an additional period of time. Any proposed regula-
tion issued under this subsection finding that a device
shall be classified in class III shall be accompanied by a
full statement of the reasons (and supporting documenta-
tion and data) of the Secretary for finding that classifica-
tion of the device in class III is necessary to provide rea-
sonable assurance of its safety and effectiveness and that
reclassification in class II will not provide such assurance.
‘‘CLASSIFICATION
‘‘(k) Any in vitro diagnostic test system intended for
human use which is intended to be introduced or delivered
for introduction into interstate commerce for commercial
distribution on or after the date of enactment of this sub-
section is deemed to be classified by the Secretary in class
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II unless the Secretary, by regulation, finds that classifica-
tion of the device in class III is necessary to provide rea-
sonable assurance of its safety and effectiveness. Any such
device that the Secretary classifies in class III shall re-
main in class III for 3 years after the effective date of
the regulation classifying the device in class III. At the
end of that 3-year period, the device is deemed to be auto-
matically reclassified by the Secretary in class II unless
the Secretary, by notice and comment rulemaking, extends
the class III designation for an additional period of time.
Any proposed regulation issued under this subsection find-
ing that a device shall be classified in class III shall be
accompanied by a full statement of the reasons (and sup-
porting documentation and data) of the Secretary for find-
ing that classification in class II will not provide such as-
surance.’’.
(b) Section 520(l)(1) (21 U.S.C. 360j(l)(1)) is
amended by adding after ‘‘has classified such device in
class I or II’’ the following: ‘‘, except that any device in-
tended for human use described in subparagraphs (A)
through (F) which is an in vitro diagnostic test system
is deemed to be classified by the Secretary in class II on
the date 1 year after the date of enactment of this para-
graph unless the Secretary in response to a petition sub-
mitted under paragraph (2) has classified such device in
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class I, or the Secretary, by regulation, finds that classi-
fication of the device in class III is necessary to provide
reasonable assurance of its safety and effectiveness. Any
such device that the Secretary classifies in class III shall
remain in class III for 3 years after the effective date of
the regulation classifying the device in class III. Any such
device that the Secretary classifies in class III shall re-
main in class III for 3 years after the effective date of
the regulation classifying the device in class III unless the
Secretary, by notice and comment rulemaking, extends the
class III designation for an additional period of time. At
the end of that 3-year period, the device is deemed to be
automatically reclassified by the Secretary in class II. Any
proposed regulation issued under this paragraph finding
that a device shall be classified in class III shall be accom-
panied by a full statement of the reasons (and supporting
documentation and data) of the Secretary for finding that
classification of the device in class III is necessary to pro-
vide reasonable assurance of its safety and effectiveness
and that reclassification in class II will not provide such
assurance’’.
SEC. 11. REGULATION OF SPECIAL PURPOSE REAGENTS.
Section 513 (21 U.S.C. 360c), as amended by section
8, is amended by adding at the end the following:
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‘‘SPECIAL PURPOSE REAGENTS
‘‘(l) Any special purpose reagent is deemed to be clas-
sified by the Secretary in class I, subject to the ‘general
controls’ defined in subsection (h), except the premarket
notification requirement of section 510(k), if—
‘‘(1) the labeling complies with all requirements
that the Secretary, by regulation, establishes for in
vitro diagnostic test systems, including a require-
ment that a certificate of analysis provided by the
manufacturer of the special purpose reagent shall be
limited to a description of the physical and chemical
properties of the device, the quantity provided, ap-
propriate storage instruction, expiration date, and
the results of any quality or purity testing conducted
by the manufacturer;
‘‘(2) the label for the device bears the statement
‘For manufacturing or laboratory use only,’; and
‘‘(3) distribution of the device is restricted to
laboratories licensed by the Secretary under section
353 of the Public Health Service Act to perform
‘high complexity’ testing as the Secretary, by regula-
tion, defines.
‘‘IN VITRO DIAGNOSTIC TEST SYSTEM
‘‘(m) Any laboratory licensed by the Secretary under
section 353 of the Public Health Services Act to perform
‘high complexity’ testing which uses a special purpose rea-
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gent to manufacture an in vitro diagnostic test system
only for use in that laboratory shall validate the in vitro
diagnostic test system. The laboratory shall include the
following statement on all labeling and any patent test re-
port: ‘Proprietary assay developed and validated by [name
of laboratory]. The performance characteristics of this
assay have not been cleared or approved by the Food and
Drug Administration’.’’.
SEC. 12. AUTHORIZATION OF NONGOVERNMENTAL ORGA-
NIZATIONS 
AND 
PERSONS 
TO 
CONDUCT
GOOD MANUFACTURING PRACTICE INSPEC-
TIONS AND RESPONSES TO ADVERSE FIND-
INGS.
Section 704 (21 U.S.C. 374) is amended—
(1) in subsection (a)(1), by inserting ‘‘or orga-
nizations and individuals receiving accreditation to
conduct good manufacturing practice inspections
under section 712’’ after ‘‘Secretary’’;
(2) in subsection (a)(3), by inserting ‘‘or an ac-
credited organization or individual under section
712’’ after ‘‘employee’’;
(3) in subsection (b), by inserting ‘‘, or the ac-
credited organization or individual under section
712,’’ after ‘‘employee’’;
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(4) in subsection (b), by inserting ‘‘(1)’’ after
‘‘(b)’’, redesignating clauses (1) and (2) as clauses
(A) and (B), respectively, and adding at the end the
following:
‘‘(2) The Secretary shall provide at least 10 days
from the date of presentation of the findings in paragraph
(1) for the person receiving such findings to respond. The
Secretary shall take no regulatory action against a person
or article subject to the requirements of the Act until com-
pleting a review of such a response, which is timely sub-
mitted to the Secretary, except the Secretary may take
immediate action when the Secretary finds that there is
a reasonable probability that a device intended for human
use would cause serious, adverse health consequences or
death, or that any regulated article could present an un-
reasonable and substantial risk of injury or illness to the
public health. The Secretary shall provide to the regulated
person, within 30 days of receiving a response to findings
identified in paragraph (1), a detailed assessment of the
response.
‘‘(3) At the time an accredited organization or indi-
vidual shall identify in writing each inspectional finding
observed during such inspection which suggests a devi-
ation from requirements under the Act. Within 30 days
from the date of presentation of such findings, the person
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receiving the findings shall respond in writing to the ac-
credited organization or individual stating the response of
such person to each finding. Within 30 days of receipt of
such response, the accredited organization or individual
shall prepare and submit a written report to the Secretary,
including inspectional findings, the regulated person’s re-
sponse to the findings, an assessment of the adequacy of
the response and conclusions, and a copy of the conflict
of interest assessment prepared in accordance with the re-
quirement set forth in section 712(c). Such accredited or-
ganization or individual shall immediately submit to the
Secretary the inspectional findings when the device to
which such findings relate is intended for human use and
presents a reasonable probability that such device would
cause serious, adverse health consequences or death, or
that any regulated article could present an unreasonable
and substantial risk of injury or illness to the public
health.’’; and
(5) by adding after subsection (e) the following:
‘‘(f) Persons duly designated by the Secretary to con-
duct inspections under this section shall not request any
information not permitted under subsections (a) and (e)
unless such person states with specificity and in writing
the identification of the information subject to the request,
the reason for the request, and that the written request
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seeks to obtain information not required to be produced
under this section.’’.
SEC. 13. ACCREDITATION OF NONGOVERNMENTAL ORGANI-
ZATIONS OR INDIVIDUALS.
Subchapter A of chapter VII is amended by adding
the following:
‘‘ACCREDITATION OF NONGOVERNMENTAL
ORGANIZATIONS OR INDIVIDUALS
‘‘SEC. 712. (a) The Secretary shall, within 180 days
after the date of enactment of this section, by regulation
establish procedures and criteria to accredit any organiza-
tion or individuals for purposes of—
‘‘(1) conducting good manufacturing practice
inspections authorized under section 704 to deter-
mine the conformance of a facility with regulations
promulgated under section 520(f);
‘‘(2) reviewing notifications required under sec-
tion 510(k) and making written recommendations of
initial classification under section 513(f)(1) of de-
vices; and
‘‘(3) reviewing applications under section 515(c)
and providing written reviews to the Secretary deter-
mine, within 120 days from the receipt of a submis-
sion requesting accreditation, whether the organiza-
tion or individual submitting such application is fit
to undertake some or all of the activities specifies
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herein. The Secretary shall notify the applicant in
writing of the Secretary’s determination within such
time period.
‘‘(b) The Secretary shall take into account the train-
ing and experience of organizations and individuals who
apply for accreditation, including formal education, certifi-
cations, work experience, ability to protect the confiden-
tiality of trade secret and confidential commercial and fi-
nancial information, lack of bias and other related infor-
mation necessary to determine the fitness of an applicant
to undertake activities on behalf of the Department of
Health and Human Services.
‘‘(c) Notwithstanding the credentials or qualifications
of any applicant, the Secretary shall, after accreditation
require each person who chooses to use an accredited orga-
nization or individual to determine whether such organiza-
tion or individual has a significant personal or financial
interest in a device, other than compensation for reviews
or inspections, that would influence decisions regarding
such device.’’.
SEC. 14. RESEARCH ACTIVITIES.
(a) ACTIVITIES.—Chapter IX, as amended by section
11, is amended by adding after section 906 the following:
‘‘RESEARCH ACTIVITIES
‘‘SEC. 907. Research activities of the Food and Drug
Administration relating to drugs, devices, and biological
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products, 
which 
are 
authorized 
under 
section
903(b)(2)(D) and section 352 of the Public Health Service
Act, shall directly relate to the review and approval of
drugs, devices, and biological products. In conducting such
research activities, the Food and Drug Administration
may collaborate with the National Institutes of Health,
academic health centers, and other scientific institutions
and the drug and device industry.’’.
(b) PURPOSE.—Section 903 (21 U.S.C. 393), as
amended by section 3, is amended by adding at the end
the following:
‘‘(e) Any research conducted by or for the Food and
Drug Administration shall be solely related directly to (1)
the regulatory mission or (2) professional staff develop-
ment related to that mission and shall be limited to the
minimum necessary to achieve such purposes.’’.
SEC. 15. POLICY AND PERFORMANCE REVIEW.
Section 514 (21 U.S.C. 360d) is amended by adding
the following:
‘‘(c)(1) The Secretary shall recognize applicable na-
tionally or internationally recognized consensus standards
to determine whether there is a reasonable assurance that
a device is safe or effective or to determine compliance
with any requirement under the Act, except that, any per-
son may elect to submit data other than that required by