shall be considered to be made to a section or other provi-
sion of the Federal Food, Drug, and Cosmetic Act.
SEC. 2. DESIGNATION AND REGULATION OF COMBINATION
AND SINGLE ENTITY PRODUCTS.
Section 503(g) is amended by redesignating para-
graph (4) as (5) and inserting after paragraph (3) the
following paragraph:
‘‘(4)(A) Within six months after the date of the en-
actment of the Medical Device Amendments of 2001, the
Secretary shall establish within the Office of the Commis-
sioner of Food and Drugs an office to be known as the
Office of Combination Products and Product Jurisdiction
(referred to in this paragraph as the ‘Office’), which shall
be responsible for designating the Center with primary or
exclusive responsibility for the premarket and postmarket
regulation of drugs, devices and biological products. The
Office shall be managed by a person with appropriate sci-
entific expertise and shall oversee the regulation of such
products to ensure timely and effective premarket reviews,
and predictable and consistent postmarket requirements.
‘‘(B) The Office shall assign for regulation all prod-
ucts subject to this Act based on the primary mode of ac-
tion. The component within the Food and Drug Adminis-
tration with primary or exclusive responsibility for regu-
lating a product shall be determined according to the re-
quirements of subparagraphs (A) through (C) of para-
graph (1). All products which meet the definition of device
or drug within the meaning of section 201, or biological
product as defined under section 351(i) of the Public
Health Service Act shall be regulated only by the persons
within the Food and Drug Administration who are pri-
marily charged with the regulation of such products. In
vitro reagents, as that term is used in section 201(h), shall
be regulated by those persons within the Food and Drug
Administration primarily charged with reviewing devices.
‘‘(C)(i) The assignment of a product to a component
of the Food and Drug Administration shall be for pur-
poses of premarket and postmarket regulation.
‘‘(ii) After such an assignment, all persons associated
with shared premarket reviews, including reviews with
input from a consulting agency component or reviews in
which more than one premarket clearance is necessary,
shall be responsible to and under the supervision of the
Office for purposes of such reviews.
‘‘(iii) Any disputes regarding the timeliness or sub-
stance of such reviews may be presented to the Office for
resolution. The decision of the Office shall be subject ex-
clusively to review by the Commissioner of Food and
Drugs and such review shall not be delegated.
‘‘(iv) The postmarket regulatory requirements for
combination products shall be under the same type of
product authorities as those relied upon to approve, clear,
or license such products, unless two types of product au-
thorities are necessary to permit the commercial distribu-
tion of a combination product. When more than one type
of product authority is necessary to permit the commercial
distribution of a combination product, each component of
such product shall be subject to the postmarket require-
ments of the regulatory authority relied upon to permit
the commercial distribution of each such component com-
prising the combination product.
‘‘(D) The Office shall not be bound by any existing
agreement, guidance or agency practice recommending as-
signment or assigning any device, drug, biological product,
or combination product to any component of the Food and
Drug Administration, unless the product is assigned to the
agency component primarily charged with regulating each
such product. The Office shall review each agency agree-
ment, guidance or practice and determine whether they
are consistent with the requirements of this subsection.
As part of the review process, the Office shall publish for
comment each such agreement, guidance or statement of
practices. After receipt and analysis of comments, the Of-
fice shall determine whether to adopt, and to what extent,
any of the agency’s existing agreements, guidance docu-
ments or practices.
‘‘(E) One year after the date of the enactment of the
Medical Device Amendments of 2001 and for each year
thereafter, the Secretary shall report to the appropriate
committees of Congress the accomplishments, including
the impact on the efficiency and quality of product regula-
tion, of the Office. Among other things, such report shall
describe the activities of the Office, identify the number
of premarket reviews involving more than one review com-
ponent of the Food and Drug Administration, discuss the
timeliness and consistency of combination product pre-
market reviews, and demonstrate the Office’s progress or
lack of progress in ensuring timely and effective reviews
of such products.’’.
SEC. 3. STRENGTHENING THIRD PARTY REVIEW OF PRE-
MARKET NOTIFICATION.
Section 523 (21 U.S.C. 360m) is amended—
(1) in subsection (a), by striking paragraph (3)
and inserting the following:
‘‘(3) ELIGIBLE DEVICES.—
‘‘(A) IN GENERAL.—Each type of device
subject to the requirement of premarket notifi-
cation under section 510(k) shall be eligible for
review by persons accredited under subsection
(a), unless the Secretary after notice and com-
ment promulgates a regulation excluding a type
of device or specific devices within a type from
review by accredited persons under this section.
‘‘(B) EXCEPTION.—Any type of device or
specific device that was eligible for premarket
notification review by persons accredited under
this section six months prior to the date of the
enactment of the Medical Device Amendments
of 2001 shall continue to be eligible for such re-
view, unless the Secretary determines that pre-
market notification by the Secretary is nec-
essary to assure reasonable assurance of safety
and effectiveness. After making this determina-
tion, the Secretary shall promulgate a regula-
tion after notice and comment rulemaking to
exclude such a type of device or specific device
from review under this section.’’; and
(2) by striking subsection (c).
SEC. 4. AUGMENTING EXPERTISE.
(a) CENTER
FOR
DEVICES
FELLOWSHIP
PRO-
GRAM.—The Federal Food, Drug and Cosmetic Act is
amended by adding at the end the following:
‘‘SEC. 908. DEVICES FELLOWSHIP PROGRAM.
‘‘(a) IN GENERAL.—Without regard to the provisions
of title 5, United States Code, governing appointments in
the competitive service and without regard to the provi-
sions of chapter 51 and subchapter III of chapter 53 of
such title relating to classification and General Schedule
pay rates, the Commissioner of Food and Drugs may es-
tablish a fellowship program within the component of the
agency responsible for regulating devices for the purpose
of augmenting and enriching the scientific expertise of
that agency component. Any person receiving such a fel-
lowship shall be available to participate in any matter in
which the participation of such person would not create
a conflict of interest, and shall be subject to the same re-
quirements applicable to full time employees regarding the
protection and use of trade secret and confidential com-
mercial or financial information.
‘‘(b) ELIGIBILITY.—Any qualified person not an em-
ployee of the Federal or a state government may be eligi-
ble for the fellowship identified in subsection (a). The
granting of a fellowship to the candidate shall be the result
of the unanimous agreement of a group of five (5) senior
officials designated by the Commissioner, including at
least three from the component of the Food and Drug Ad-
ministration responsible for regulating devices. These offi-
cials shall evaluate the technical background and achieve-
ments of each candidate, the significance of the can-
didate’s expertise to the agency’s needs, and the can-
didate’s character and likely contributions to the agency.’’.
(b) OUTSIDE EXPERT REVIEWS.—Section 515(c) (21
U.S.C. 360e(c) is amended by adding at the end the fol-
lowing:
‘‘(3)(A) Either at the initiation of the Secretary or
the applicant, any person who is (i) not an employee of
the Federal or a state government, and (ii) an expert in
a subject matter germane to an application under para-
graph (1) may be selected by the Secretary to review all
or part of a premarket approval application submitted
under this section, after considering recommendations of
experts from applicants, if any. The decision to use such
an expert shall be made by agreement between the Sec-
retary and the applicant, and the applicant may choose
not to retain an expert for any reason, including the cost
of the expert’s compensation. The compensation for such
an expert review shall be determined by the expert and
the applicant.
‘‘(B) The Secretary shall prescribe the terms of the
review, including the amount of time allocated to such ex-
perts to submit to the Secretary and the applicant a report
and recommendation evaluating that portion of the appli-
cation the Secretary designated for review.
‘‘(C) The Secretary shall promptly consider the rec-
ommendation of an expert reviewer and provide a detailed
written explanation of any portion of the recommendation
with which the Secretary disagrees.’’.
(c) INSPECTIONS BY ACCREDITED PERSONS.—Sec-
tion 704 (21 U.S.C. 374) is amended by adding at the
end the following:
‘‘(g)(1) Not later than one year after the date of the
enactment of the Medical Device Amendments of 2001,
the Secretary shall accredit persons to conduct inspections
authorized under subsection (a) at facilities designated as
eligible for inspections by accredited persons who are not
employees of the Federal or a state government. The
owner or operator of an eligible facility shall have the op-
tion to use an accredited person in lieu of officers or em-
ployees designated by the Secretary to conduct such in-
spections, including inspections to satisfy the good manu-
facturing practice requirements of section 515.
‘‘(2) Not later than 180 days after the date of the
enactment of the Medical Device Amendments of 2001,
the Secretary shall publish in the Federal Register criteria
to accredit or deny accreditation to persons who request
to perform the duties specified in paragraph (1). There-
after, the Secretary shall respond to a request for accredi-
tation within 60 days of the receipt of a request. The ac-
creditation shall state that such person is accredited to
conduct device facility inspections under subsection (a).
‘‘(3) An accredited person shall, at a minimum, meet
the following requirements:
‘‘(A) Such person shall be an independent orga-
nization which is not owned or controlled by a man-
ufacturer, supplier, or vendor of articles regulated
under the Act and which has no organizational, ma-
terial, or financial affiliation with such a manufac-
turer, supplier, or vendor.
‘‘(B) Such person shall be a legally constituted
entity permitted to conduct the activities for which
it seeks accreditation.
‘‘(C) Such person shall not engage in the de-
sign, manufacture, promotion, or sale of articles reg-
ulated under the Act.
‘‘(D) The operations of such person shall be in
accordance with generally accepted professional and
ethical business practices and such persons shall
agree in writing that as a minimum it will—
‘‘(i) certify that reported information accu-
rately 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 confidential
commercial or financial information or trade se-
cret information; and
‘‘(iv) protect against the use, in carrying
out paragraph (1), of any officer or employee of
the accredited person who has a financial con-
flict of interest regarding any product regulated
under the Act, and annually make available to
the public disclosures of the extent to which the
accredited person, and the officers and employ-
ees of the person, have maintained compliance
with requirements under this clause relating to
financial conflicts of interest.
‘‘(4) The Secretary shall publish a list of accredited
persons to conduct inspections under subsection (a) on the
Food and Drug Administration’s web page. Those who
elect to employ an accredited person shall select such a
person from the list posted by the Secretary. Such list
shall be periodically updated to ensure that the identity
of each accredited person is known to the public. The up-
dating of such list shall be no later than one month after
the accreditation of a person under this subsection.
‘‘(5) To ensure that persons accredited under this
subsection continue to meet the standards of accredita-
tion, the Secretary shall (i) audit the performance of such
persons on a periodic basis; and (ii) take such additional
measures as the Secretary deems appropriate, including
the withdrawal of accreditation when persons accredited
under this subsection fail to maintain compliance with the
accreditation criteria established by the Secretary.
‘‘(6) Device facilities in which the Secretary classified
the results of the facility’s most recent inspection under
subsection (a) as ‘‘no action indicated’’ or ‘‘voluntary ac-
tion indicated’’, or those facilities in which after the most
recent inspection, the Secretary determines that satisfac-
tory compliance with section 520(f) supports the approval
of a device under section 515, shall be eligible for inspec-
tions by persons accredited by the Secretary under para-
graph (2). The Federal Food and Drug Administration
shall not inspect an eligible facility unless—
‘‘(A) the facility is not inspected by an accred-
ited person for the 2 year period following the date
of a ‘‘no action indicated’’ or ‘‘voluntary action indi-
cated’’ finding by the Secretary;
‘‘(B) after an inspection by the Secretary, or
after the Secretary’s review of a report of an inspec-
tion from an accredited person, the Secretary deter-
mines in writing that a facility is no longer eligible
for inspections by accredited persons; or
‘‘(C) the Secretary has good cause for con-
ducting an inspection.
‘‘(7) Persons accredited under this subsection to con-
duct inspections shall record in writing their inspection ob-
servations and shall present to the device facility’s des-
ignated representative and discuss each observation. Addi-
tionally, such accredited person shall prepare an inspec-
tion report in a form and manner consistent with such
reports prepared by employees and officials designated by
the Secretary to conduct inspections under subsection (a).
At a minimum, such reports shall identify the persons re-
sponsible for good manufacturing practice compliance at
an inspected establishment, discuss in detail each observa-
tion identified by the accredited person, identify other
matters that relate or may influence compliance with the
Act, and discuss any recommendations made during the
inspection or at the inspection’s closing meeting. The re-
port of the inspection shall be sent to the Secretary and
the designated representative of an inspected facility at
the same time, but under no circumstances later than 3
weeks after the last day of the inspection.
‘‘(8) Compensation for an accredited person shall be
determined by agreement between the accredited person
and the person who engages the services of the accredited
person, and shall be paid by the person who engages such
services.’’.
SEC. 5. SPECIAL PROCESS FOR BREAKTHROUGH TECH-
NOLOGIES.
Section 
515(d)(5) 
(21 
U.S.C. 
360e(d)(5)) 
is
amended—
(1) by redesignating subparagraphs (A) through
(D) as clauses (i) through (iv), respectively;
(2) by inserting ‘‘(A)’’ after ‘‘(5)’’; and
(3) by adding at the end the following subpara-
graph:
‘‘(B)(i) In order to provide patients with the benefits
of devices referenced in subparagraph (A) in the treatment
and diagnosis of serious diseases or conditions, the Sec-
retary shall within six months after the date of the enact-
ment of the Medical Device Amendments of 2001 promul-
gate a regulation setting forth a process to designate de-
vices as ‘priority devices’. Such regulation shall include,
among other things, requirements for (I) the specification
of the contents of submissions requesting priority status;
(II) a meeting to fully discuss the submission; (III) a writ-
ten response no later than 30 days after the receipt of
a submission granting or denying priority status; and (IV)
an administrative appeal before the director or a deputy
director of the Office of Device Evaluation, or any suc-
cessor unit, within 10 days of a written determination de-
nying a device a priority designation. A request for a pri-
ority device designation may be made at any time, includ-
ing times prior to the investigation of a device.
‘‘(ii) A device which the Secretary designates as a pri-
ority device shall be subject to a review period of no longer
than 120 days following the designation determination, at
which time the Secretary shall approve or deny the appli-
cation submitted to support approval of the device. The
determination to approve or deny a premarket application
for a priority device shall take into consideration the fol-
lowing in determining a reasonable assurance of device
safety and effectiveness:
‘‘(I) Whether the likely risk to expected health
of patients is less from using a priority device than
the risk of not having the device available to treat
or diagnose a disease or condition.
‘‘(II) Whether the amount of benefit from a pri-
ority device would exceed the benefit for an indi-
vidual patient relative to no treatment or diagnosis,
or to alternative means of treatment or diagnosis.
‘‘(III) A comparison of risk to benefit as de-
scribed in subclauses (I) and (II), respectively.
‘‘(iii)(I) The Secretary, in the context of a meeting
under section 520(g)(7), shall agree, when appropriate, to
review data at an interim point in a clinical trial for pur-
poses of determining reasonable assurance of device safety
and effectiveness. Such interim reviews shall be subject to
the conditions that the Secretary deems appropriate, in-
cluding that the approval will become null and void if it
is demonstrated at a consultation with the Director of the
Office of Device Evaluation (or any successor unit) that
the conclusions based on data from the completed clinical
trial are inconsistent with those from the interim analysis
and such conclusions would have resulted in denial of the
application.
‘‘(II) The Secretary shall rely on appropriate
endpoints, including surrogate endpoints, when evaluating
an application for a priority device to determine whether
there exists a reasonable assurance of safety and effective-
ness.
‘‘(iv) To ensure a complete, fully informed and timely
review of applications for priority devices, the Secretary
shall include in the regulation referenced in subparagraph
(B)(i) a provision requiring persons responsible for review-
ing applications for such devices to meet with applicants
to jointly consider such applications. Such meetings shall
commence not later than the ninetieth day after receipt
of an application that satisfies the criteria for complete-
ness set forth in subsection (c). Such meetings shall pro-
vide adequate time for applicants and government employ-
ees to review an entire submission to ensure that appli-
cants can quickly and effectively supplement applications
for priority devices.’’.
SEC. 6. INCREASING REPORTING EFFECTIVENESS.
Section 519(a)(1) (21 U.S.C. 360i(a)(1)) is amended
by inserting after and below subparagraph (B) the fol-
lowing:
‘‘except that such reports shall only be required
when the Secretary identifies a type of device in the
Federal Register for which the Secretary intends to
require malfunction reporting, which malfunction re-
porting shall be in effect after a 60 day comment pe-
riod and the Secretary’s Federal Register announce-
ment that a type of device is subject to such report-
ing, and which malfunction reporting shall be on a
quarterly basis, and shall be limited to information
describing the device and the event, the date and lo-
cation of the event, and the identity of the person
at the facility or place where the event occurred
upon whom the reporter relied for information;’’.
SEC. 7. INDICATIONS FOR USE.
(a) PREMARKET
NOTIFICATION
PROPOSED
IN-
TENDED
USE.—Section 
513(i)(1)(E) 
(21 
U.S.C.
360c(i)(1)(E)) is amended by striking clause (iv).
(b) PREMARKET APPROVAL PROPOSED CONDITIONS
OF
USE.—Section 
515(d)(1)(A) 
(21 
U.S.C.
360e(d)(1)(A)) is amended by adding at the end the fol-
lowing: ‘‘Whenever the Secretary determines that pro-
posed labeling is false or misleading, the Secretary shall,
no later than 150 days after receipt of an application filed
under subsection (c), notify the applicant in writing of the
basis for such a determination.’’.
(c) SUPPLEMENTS
FOR CERTAIN CONDITIONS
OF
USE.—Section 515(d)(6) (21 U.S.C. 360e(d)(6)) is
amended by adding at the end the following subparagraph:
‘‘(C)(i) Subject to clause (ii), in reviewing any supple-
ment to an approved application, which is submitted to
obtain the additional specification of a subpopulation
under an approved condition of use, the Secretary shall
approve such supplement without additional clinical data
when—
‘‘(I) the underlying conditions of use of the de-
vice are otherwise unchanged from that approved by
the Secretary; and
‘‘(II) preclinical and clinical data exist in the
approved application applicable to the safe and effec-
tive use of the device in the specified subpopulation,
or a bona fide peer review journal article reporting
clinical experience with the device in the subpopula-
tion demonstrates that there is reasonable assurance
of the device’s safety and effectiveness.
‘‘(ii) In evaluating an indication for such a patient
subpopulation, the Secretary may require, when necessary,
the submission of clinical data to determine whether there
is a reasonable assurance of safety and effectiveness.’’.
SEC. 8. IMPROVING COLLABORATION.
(a) LEAST BURDENSOME DETERMINATIONS.—Sec-
tion 
513(a)(3)(D) 
(21 
U.S.C. 
360c(a)(3)(D)) 
is
amended—
(1) in clause (i), by inserting ‘‘within 20 days
of such a request’’ after ‘‘section 515, shall’’; and
(2) by striking clause (ii) and inserting the fol-
lowing:
‘‘(ii) Any clinical data and other valid scientific evi-
dence, specified in writing by the Secretary to demonstrate
reasonable assurance of device effectiveness shall rep-
resent a determination by the Secretary that such evidence
is the least burdensome information necessary to satisfy
a finding of effectiveness for purposes of approving a de-
vice under subsection 515(d).’’.
(b) INVESTIGATIONAL PLAN AGREEMENT MEET-
INGS.—Section 520(g)(7) (21 U.S.C. 360j(g)(7)) is
amended—
(1) in subparagraph (A)—
(A) by striking the first sentence and in-
serting the following: ‘‘In the case of a person
intending to investigate the safety and effective-
ness or substantial equivalence of a device, and
such investigation includes the undertaking of a
clinical trial, the Secretary shall ensure that
such person has an opportunity, prior to sub-
mitting an application under section 515 or a
premarket notification under section 510(k) to
the Secretary or an institutional review com-
mittee, to submit to the Secretary an investiga-
tional plan (including a clinical protocol) for re-
view.’’; and
(B) by striking the last sentence and in-
serting the following: ‘‘The written request shall
include a detailed description of the device, in-
cluding the device’s proposed indications or con-
ditions of use, and a proposed investigational
plan or any part of such plan to which the sub-
mitter seeks review and agreement.’’; and
(2) in subparagraph (B), in the matter pre-
ceding clause (i), by inserting after ‘‘applicant shall’’
the following: ‘‘reflect the least burdensome informa-
tion necessary to support an approval under section