I
103D CONGRESS
2D SESSION
H. R. 4728
To amend the Federal Food, Drug, and Cosmetic Act to authorize a device
application fee, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
JULY 12, 1994
Mr. WAXMAN (for himself and Mr. DINGELL) introduced the following bill;
which was referred to the Committee on Energy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
authorize a device application fee, and for other purposes.
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
‘‘Medical Device User Fee Act of 1994’’.
(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-
sion of the Federal Food, Drug, and Cosmetic Act.
SEC. 2. FINDINGS.
The Congress finds that—
(1) prompt approval and clearance of safe and
effective devices is critical to the improvement of the
public health so that patients may enjoy the benefits
of devices to diagnose, treat, and prevent disease;
(2) the public health will be served by furnish-
ing additional funds for the review of devices so that
statutorily mandated deadlines may be met, and
(3) the fees authorized by the amendment made
by section 3 will be dedicated—
(A) toward expediting the review of device
applications, 
supplements, 
and 
substantial
equivalence submissions, and
(B) for related activities as defined in sec-
tion 741(3) of the Federal Food, Drug, and
Cosmetic Act,
as set forth in goals identified in the letter of July
8 , 1994, from the Commissioner of Food and Drugs
to the Committee on Energy and Commerce of the
House of Representatives and the Committee on
Labor and Human Resources of the Senate.
SEC. 3. FEES RELATING TO DEVICES.
Chapter VII is amended by adding at the end of sub-
chapter C the following:
‘‘PART 3—FEES RELATING TO DEVICES
‘‘SEC. 741. DEFINITIONS.
‘‘For purposes of this subchapter:
‘‘(1) The term—
‘‘(A) ‘device application’ means an applica-
tion for approval of a device submitted under
section 515(c) or section 351 of the Public
Health Service Act, a supplement to such an
application, or a device substantial equivalence
submission made under section 510(k); and
‘‘(B) ‘section 351 application’ means a de-
vice application submitted under section 351 of
the Public Health Service Act.
‘‘(2) The term ‘supplement’ means a request to
the Secretary to approve a change in a device appli-
cation which has been approved under section
515(d) or section 351 of the Public Health Service
Act.
‘‘(3) The term ‘process for the review of device
applications and related activities’ means the follow-
ing activities of the Secretary with respect to the re-
view of device applications and related activities:
‘‘(A) The activities necessary for the
review of device applications and related
activities.
‘‘(B) The issuance of action letters which
allow marketing of devices or which set forth in
detail the specific deficiencies in such applica-
tions and, where appropriate, the actions nec-
essary to place such applications in condition
for approval.
‘‘(C) The inspection of device establish-
ments and other facilities undertaken as part of
the Secretary’s review of pending device appli-
cations.
‘‘(D) Activities necessary for the review of
applications for licensure of devices subject to
section 351 of the Public Health Service Act,
for the licensure of establishments where such
devices are manufactured, and for the release of
lots of such devices.
‘‘(E) Review of device applications for an
investigational new drug exemption under sec-
tion 505(i) and for an investigational device ex-
emption under section 520(g) and activities
conducted in anticipation of the submission of
an application under sections 505(i) and
520(g).
‘‘(F) The development of guidance and pol-
icy documents to improve the process for the
review of device applications.
‘‘(G) The development of test methods and
standards in connection with the review of de-
vice applications and related activities.
‘‘(H) The provision of technical assistance
to device manufacturers in connection with the
submission of a device application.
‘‘(I) Activities undertaken in connection
with the export of a device.
‘‘(J) Activities undertaken under sections
513 and 515(i) in connection with the initial
classification and reclassification of a device
and under section 515(b) in connection with
any requirement for premarket approval of a
device.
‘‘(K) Monitoring of research.
‘‘(L) Activities undertaken under sections
519(a) and 519(b).
‘‘(M) Postmarket studies required as a
condition of an approval of a device application
under section 515(d) or section 351 of the Pub-
lic Health Service Act.
‘‘(N) Postmarket surveillance required
under section 522.
‘‘(4) The term ‘costs of resources allocated for
the process for the review of device applications and
related activities’ means the expenses incurred in
connection with the process for the review of device
applications and related activities for—
‘‘(A) officers and employees of the Food
and Drug Administration, employees under con-
tract with the Food and Drug Administration,
advisory committees, and costs related to such
officers, employees, and committees,
‘‘(B) management of information, and the
acquisition, maintenance, and repair of com-
puter resources,
‘‘(C) leasing, maintenance, renovation, and
repair of facilities and acquisition, maintenance,
and repair of fixtures, furniture, scientific
equipment, and other necessary materials, serv-
ices, and supplies, and
‘‘(D) collecting fees under section 742 and
accounting for resources allocated for the re-
view of device applications and related activi-
ties, including activities related to the review of
applications for fee exceptions, waivers, and
reductions.
‘‘(5) The term ‘adjustment factor’ applicable to
a fiscal year is the lower of—
‘‘(A) the Consumer Price Index for all
urban consumers (all items; United States city
average) for August of the preceding fiscal year
divided by such Index for August 1994, or
‘‘(B) the total budget authority provided
for discretionary programs for the immediately
preceding fiscal year (as reported in the Office
of Management and Budget sequestration pre-
view report, if available, required under section
254(d) of the Balanced Budget and Emergency
Deficit Control Act of 1985) divided by such
budget authority for fiscal year 1994 (as re-
ported in the Office of Management and Budget
final sequestration report submitted after the
end of the 103d Congress, 2d Session).
The term ‘budget authority’ in subparagraph (B) is
as defined in the Balanced Budget and Emergency
Deficit Control Act of 1985, as in effect as of Janu-
ary 1, 1994.
‘‘SEC. 742. AUTHORITY TO ASSESS AND USE DEVICE USER
FEES.
‘‘(a) FEES.—Beginning in fiscal year 1995, the Sec-
retary shall assess and collect fees as follows:
‘‘(1) GENERAL RULE.—Except as provided in
paragraph (2), each person that submits, on or after
90 days before—
‘‘(A) the date of the enactment of the Med-
ical Device User Fee Act of 1994, or
‘‘(B) the date of the enactment of the first
appropriation under subsection (g)(4) for fees
under this section,
whichever occurs later, a device application shall be
subject to the fee prescribed by subsection (b).
‘‘(2) EXCEPTION.—
‘‘(A) FURTHER
MANUFACTURING
USE.—
No fee shall be required for the submission of
a section 351 application for a product licensed
for further manufacturing use only.
‘‘(B) EXCEPTION FOR PREVIOUSLY FILED
APPLICATION OR SUPPLEMENT.—If a device ap-
plication was—
‘‘(i) submitted by a person that paid
the fee for such application,
‘‘(ii) accepted for filing, and
‘‘(iii) not approved or withdrawn
(without a waiver under subsection (d)),
the submission of a device application for the
identical device by the same person (or the per-
son’s licensee, assignee, or successor) shall not
be subject to a fee under paragraph (1).
‘‘(3) PAYMENT SCHEDULE.—
‘‘(A) GENERAL RULE.—Except as provided
in subparagraph (B), the fee prescribed by sub-
section (b) shall be due upon the submission of
the application.
‘‘(B) EXCEPTIONS.—
‘‘(i) PENDING.—In the case of a de-
vice application for which fees are required
under paragraph (1) and which is pending
on the later of—
‘‘(I) the date of the enactment of
the Medical Device User Fee Act of
1994, or
‘‘(II) the date of the enactment
of the first appropriation under sub-
section (g)(4) for fees under this sec-
tion,
the fee required by paragraph (1) shall be
due 90 days after such later date of enact-
ment.
‘‘(ii) EXCESS OF AUTHORIZATION.—A
fee which is due after an amount of fees
equal to the authorization of appropria-
tions under subsection (g)(4) for the fiscal
year in which the fee is imposed has been
collected shall be due on November 1 in
the following fiscal year.
‘‘(4) REFUND IF APPLICATION OR SUPPLEMENT
NOT ACCEPTED FOR FILING.—
‘‘(A) 515(c) AND 351.—The Secretary shall
refund 85 percent of the fee paid under para-
graph (3) for any application submitted under
section 515(c) or section 351 of the Public
Health Service Act which is not accepted for fil-
ing.
‘‘(B) SUPPLEMENTS.—The Secretary shall
refund 85 percent of the fee paid under para-
graph (3) for any supplement with required
clinical data which is not accepted for filing and
shall refund the fee paid under such paragraph
for any supplement without required clinical
data which is not accepted for filing.
‘‘(C) 510(k).—The Secretary shall refund
the fee paid under paragraph (3) for any sub-
stantial equivalence submission under section
510(k) which is not accepted for filing.
‘‘(b) FEE AMOUNTS.—
‘‘(1) AMOUNT.—Except as provided in para-
graph (2) and subsections (c), (d), (f), and (g), the
fees required under subsection (a) are as follows:
‘‘(A) $52,000 for applications submitted
under section 515(c) and applications for de-
vices submitted under section 351 of the Public
Health Service Act,
‘‘(B) $7,100 for a supplement with re-
quired clinical data,
‘‘(C) $4,500 for a supplement without re-
quired clinical data, and
‘‘(D) $3,200 for a submission under sec-
tion 510(k).
‘‘(2) SMALL BUSINESS EXCEPTION.—
‘‘(A) APPLICATIONS AND SUBMISSIONS.—
Any person employing fewer than 20 employees,
including employees of affiliates, and which
does not have a device introduced or delivered
for introduction into interstate commerce under
a device application—
‘‘(i) shall pay one-half the amount of
the fee prescribed by paragraph (1)(A) one
year after the date of final action by the
Secretary on an application of such person
which is subject to such fee, and
‘‘(ii) shall pay the fee prescribed by
paragraph (1)(D) for a submission made
by such person under section 510(k) one
year after the date of final action by the
Secretary on such submission.
‘‘(B) 
CERTIFICATION.—The 
Secretary
shall require any person who applies to pay a
fee in accordance with subparagraph (A) to cer-
tify such person’s qualification under such sub-
paragraph. The Secretary shall periodically
publish in the Federal Register of list of per-
sons making such certification.
‘‘(C) DEFINITION.—For purposes of this
paragraph, a person is an affiliate of another
person when—
‘‘(i) directly or indirectly, one person
controls, or has the power to control, the
other person,
‘‘(ii) directly or indirectly, a third
party controls, or has the power to control,
both persons, or
‘‘(iii) an identity of interest between
or among such persons exists such that af-
filiation may be found.
‘‘(c) ADJUSTMENTS.—
‘‘(1) 
FEE
ADJUSTMENT.—Subject 
to 
the
amount appropriated for a fiscal year under sub-
section (g), the Secretary shall, in a fiscal year be-
ginning after fiscal year 1995, adjust the fees due
in the fiscal year following the fiscal year in which
the adjustment is made to reflect the greater of—
‘‘(A) the total percentage increase that oc-
curred during the preceding fiscal year in the
Consumer Price Index for all urban consumers
(all items; U.S. city average) that exceeds 3.5
percent, or
‘‘(B) the total percentage increase for such
preceding fiscal year in basic pay under the
General Schedule in accordance with section
5332 of title 5, United States Code, as adjusted
by any locality-based comparability payment
pursuant to section 5304 of such title for Fed-
tions and meeting statutory review times applicable
to submissions for devices, and
(2) the following data from the Center for De-
vices and Radiological Health and the Center for
Biologics Evaluation and Research:
(A) The number of device submissions
found not fileable.
(B) Total elapsed time for review of device
submissions.
(C) Total time for review of device submis-
sions as calculated by such Center.
(D) Number of negative decisions for de-
vice submissions.
(E) Number of non-approveable letters for
device submissions.
(F) Number of deficiency letters for device
submissions.
(G) Information for subparagraphs (A)
through (F) for fiscal year 1994.
(b) SECOND REPORT.—Within 120 days after the
end of each fiscal year during which such fees are col-
lected, the Secretary of Health and Human Services shall
submit a report on the implementation of the authority
for such fees during such fiscal year and on the use the
Food and Drug Administration made of the fees collected
during such fiscal year for which the report is made.
(c) COMMITTEES.—The reports described in sub-
sections (a) and (b) shall be submitted to the Committee
on Energy and Commerce of the House of Representatives
and the Committee on Labor and Human Resources of
the Senate.
SEC. 5. REGULATIONS.
(a) GENERAL RULE.—This Act and the amendment
made by section 3 shall not be in effect after June 30,
1995, unless the Secretary of Health and Human Services,
through the Commissioner of Food and Drugs, approves—
(1) regulations described in subsection (b), and
(2) regulations which identify devices in class II
of the device classes in section 513 of the Federal
Food, Drug, and Cosmetic Act which are appro-
priate for exemption from the requirement of section
510(k) of such Act and exempts such devices from
such requirement following their reclassification into
class I.
(b) REGULATIONS.—
(1) PROPOSED.—Not later than 30 days after
the date of the enactment of this Act, the Secretary
shall issue proposed regulations that—
(A) identify all devices in class I of the de-
vice classes in section 513 of the Federal Food,
Drug, and Cosmetic Act which are exempt from
the requirement of section 510(k) of such Act,
and
(B) identify the criteria for selecting de-
vices for such exemption.
The Secretary shall provide an opportunity to com-
ment on such proposed regulations for 60 days after
their publication.
(2) FINAL.—Not later than 30 days after the
close of the comment period provided under para-
graph (1), the Secretary shall issue final regulations
which grant an exemption to the devices identified in
the proposed regulations which clearly meet the cri-
teria for exemption from the requirement of such
section 510(k) of the Federal Food, Drug, and Cos-
metic Act.
(c) OTHER REGULATIONS.— Not later than June 30,
1995, the Secretary shall issue final regulations for the
remainder of the devices from the list published in the pro-
posed regulations which exempts such devices from such
requirement or which continues the applicability of such
requirement.
(d) FEES.—An applicant under a substantial equiva-
lence submission under section 510(k) of the Federal
Food, Drug, and Cosmetic Act which the Secretary pro-
posed to exempt from the requirement of such section
under subsection (b)(1) shall not be required to pay a fee
for such submission unless the Secretary issues a final
regulation requiring such submission. An applicant under
a substantial equivalence submission under such section
510(k) which the Secretary exempts from the requirement
of such section under subsection (b) shall not be required
to pay a fee for such submission.
SEC. 6. SUNSET.
This Act and the amendment made by section 3 shall
not be in effect after September 30, 1999.
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HR 4728 IH——3