[House Report 108-433]
[From the U.S. Government Publishing Office]
108th Congress Report
HOUSE OF REPRESENTATIVES
2d Session 108-433
======================================================================
MEDICAL DEVICES TECHNICAL CORRECTIONS ACT
_______
March 9, 2004.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Barton of Texas, from the Committee on Energy and Commerce,
submitted the following
R E P O R T
[To accompany S. 1881]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (S. 1881) to amend the Federal Food, Drug, and
Cosmetic Act to make technical corrections relating to the
amendments made by the Medical Device User Fee and
Modernization Act of 2002, and for other purposes, having
considered the same, report favorably thereon with an amendment
and recommend that the bill as amended do pass.
CONTENTS
Page
Amendment........................................................ 1
Purpose and Summary.............................................. 5
Background and Need for Legislation.............................. 5
Hearings......................................................... 5
Committee Consideration.......................................... 5
Committee Votes.................................................. 6
Committee Oversight Findings..................................... 6
Statement of General Performance Goals and Objectives............ 6
New Budget Authority, Entitlement Authority, and Tax Expenditures 6
Committee Cost Estimate.......................................... 6
Congressional Budget Office Estimate............................. 6
Federal Mandates Statement....................................... 7
Advisory Committee Statement..................................... 7
Constitutional Authority Statement............................... 7
Applicability to Legislative Branch.............................. 7
Section-by-Section Analysis of the Legislation................... 7
Changes in Existing Law Made by the Bill, as Reported............ 8
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Medical Devices Technical Corrections
Act''.
SEC. 2. TECHNICAL CORRECTIONS REGARDING PUBLIC LAW 107-250.
(a) Title I; Fees Relating to Medical Devices.--Part 3 of subchapter
C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379i et seq.), as added by section 102 of Public Law 107-250 (116 Stat.
1589), is amended--
(1) in section 737--
(A) in paragraph (4)(B), by striking ``and for which
clinical data are generally necessary to provide a
reasonable assurance of safety and effectiveness'' and
inserting ``and for which substantial clinical data are
necessary to provide a reasonable assurance of safety
and effectiveness'';
(B) in paragraph (4)(D), by striking
``manufacturing,'';
(C) in paragraph (5)(J), by striking ``a premarket
application'' and all that follows and inserting ``a
premarket application or premarket report under section
515 or a premarket application under section 351 of the
Public Health Service Act.''; and
(D) in paragraph (8), by striking ``The term
`affiliate' means a business entity that has a
relationship with a second business entity'' and
inserting ``The term `affiliate' means a business
entity that has a relationship with a second business
entity (whether domestic or international)''; and
(2) in section 738--
(A) in subsection (a)(1)--
(i) in subparagraph (A)--
(I) in the matter preceding clause
(i) by striking ``subsection (d),'' and
inserting ``subsections (d) and (e),'';
(II) in clause (iv), by striking
``clause (i),'' and all that follows
and inserting ``clause (i).''; and
(III) in clause (vii), by striking
``clause (i),'' and all that follows
and inserting ``clause (i), subject to
any adjustment under subsection
(e)(2)(C)(ii).''; and
(ii) in subparagraph (D), in each of clauses
(i) and (ii), by striking ``application'' and
inserting ``application, report,'';
(B) in subsection (d)(2)(B), beginning in the second
sentence, by striking ``firms. which show'' and
inserting ``firms, which show'';
(C) in subsection (e)--
(i) in paragraph (1), by striking ``Where''
and inserting ``For fiscal year 2004 and each
subsequent fiscal year, where''; and
(ii) in paragraph (2)--
(I) in subparagraph (B), beginning in
the second sentence, by striking
``firms. which show'' and inserting
``firms, which show''; and
(II) in subparagraph (C)(i), by
striking ``Where'' and inserting ``For
fiscal year 2004 and each subsequent
fiscal year, where'';
(D) in subsection (f), by striking ``for filing'';
and
(E) in subsection (h)(2)(B)--
(i) in clause (ii), by redesignating
subclauses (I) and (II) as items (aa) and (bb),
respectively;
(ii) by redesignating clauses (i) and (ii) as
subclauses (I) and (II), respectively;
(iii) by striking ``The Secretary'' and
inserting the following:
``(i) In general.--The Secretary''; and
(iv) by adding at the end the following:
``(ii) More than 5 percent.--To the extent
such costs are more than 5 percent below the
specified level in subparagraph (A)(ii), fees
may not be collected under this section for
that fiscal year.''.
(b) Title II; Amendments Regarding Regulation of Medical Devices.--
(1) Inspections by accredited persons.--Section 704(g) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)), as
added by section 201 of Public Law 107-250 (116 Stat. 1602), is
amended--
(A) in paragraph (1), in the first sentence, by
striking ``conducting inspections'' and all that
follows and inserting ``conducting inspections of
establishments that manufacture, prepare, propagate,
compound, or process class II or class III devices,
which inspections are required under section 510(h) or
are inspections of such establishments required to
register under section 510(i).'';
(B) in paragraph (5)(B), in the first sentence, by
striking ``or poses'' and all that follows through the
period and inserting ``poses a threat to public health,
fails to act in a manner that is consistent with the
purposes of this subsection, or where the Secretary
determines that there is a financial conflict of
interest in the relationship between the accredited
person and the owner or operator of a device
establishment that the accredited person has inspected
under this subsection.'';
(C) in paragraph (6)(A)--
(i) in clause (i), by striking ``of the
establishment pursuant to subsection (h) or (i)
of section 510'' and inserting ``described in
paragraph (1)'';
(ii) in clause (ii)--
(I) in the matter preceding subclause
(I)--
(aa) by striking ``each
inspection'' and inserting
``inspections''; and
(bb) by inserting ``during a
2-year period'' after
``person''; and
(II) in subclause (I), by striking
``such a person'' and inserting ``an
accredited person'';
(iii) in clause (iii)--
(I) in the matter preceding subclause
(I), by striking ``and the following
additional conditions are met:'' and
inserting ``and 1 or both of the
following additional conditions are
met:'';
(II) in subclause (I), by striking
``accredited'' and all that follows
through the period and inserting
``(accredited under paragraph (2) and
identified under clause (ii)(II)) as a
person authorized to conduct such
inspections of device
establishments.''; and
(III) in subclause (II), by inserting
``or by a person accredited under
paragraph (2)'' after ``by the
Secretary'';
(iv) in clause (iv)(I)--
(I) in the first sentence--
(aa) by striking ``the two
immediately preceding
inspections of the
establishment'' and inserting
``inspections of the
establishment during the
previous 4 years''; and
(bb) by inserting ``section''
after ``pursuant to'';
(II) in the third sentence--
(aa) by striking ``the
petition states a commercial
reason for the waiver;''; and
(bb) by inserting ``not''
after ``the Secretary has not
determined that the public
health would''; and
(III) in the fourth sentence, by
striking ``granted until'' and
inserting ``granted or deemed to be
granted until''; and
(v) in clause (iv)(II)--
(I) by inserting ``of a device
establishment required to register''
after ``to be conducted''; and
(II) by inserting ``section'' after
``pursuant to'';
(D) in paragraph (6)(B)(iii)--
(i) in the first sentence, by striking ``,
and data otherwise describing whether the
establishment has consistently been in
compliance with sections 501 and 502 and
other'' and inserting ``and with other''; and
(ii) in the second sentence--
(I) by striking ``inspections'' and
inserting ``inspectional findings'';
and
(II) by inserting ``relevant'' after
``together with all other'';
(E) in paragraph (6)(B)(iv)--
(i) by inserting ``(I)'' after ``(iv)''; and
(ii) by adding at the end the following:
``(II) If, during the two-year period following clearance under
subparagraph (A), the Secretary determines that the device
establishment is substantially not in compliance with this Act, the
Secretary may, after notice and a written response, notify the
establishment that the eligibility of the establishment for the
inspections by accredited persons has been suspended.'';
(F) in paragraph (6)(C)(ii), by striking ``in
accordance with section 510(h), or has not during such
period been inspected pursuant to section 510(i), as
applicable'';
(G) in paragraph (10)(B)(iii), by striking ``a
reporting'' and inserting ``a report''; and
(H) in paragraph (12)--
(i) by striking subparagraph (A) and
inserting the following:
``(A) the number of inspections conducted by accredited
persons pursuant to this subsection and the number of
inspections conducted by Federal employees pursuant to section
510(h) and of device establishments required to register under
section 510(i);''; and
(ii) in subparagraph (E), by striking
``obtained by the Secretary'' and all that
follows and inserting ``obtained by the
Secretary pursuant to inspections conducted by
Federal employees;''.
(2) Other corrections.--
(A) Prohibited acts.--Section 301(gg) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 331(gg)), as
amended by section 201(d) of Public Law 107-250 (116
Stat. 1609), is amended to read as follows:
``(gg) The knowing failure to comply with paragraph (7)(E) of section
704(g); the knowing inclusion by a person accredited under paragraph
(2) of such section of false information in an inspection report under
paragraph (7)(A) of such section; or the knowing failure of such a
person to include material facts in such a report.''.
(B) Electronic labeling.--Section 502(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
352(f)), as amended by section 206 of Public Law 107-
250 (116 Stat. 1613), is amended, in the last
sentence--
(i) by inserting ``or by a health care
professional and required labeling for in vitro
diagnostic devices intended for use by health
care professionals or in blood establishments''
after ``in health care facilities'';
(ii) by inserting a comma after ``means'';
(iii) by striking ``requirements of law and,
that'' and inserting ``requirements of law, and
that'';
(iv) by striking ``the manufacturer affords
health care facilities the opportunity'' and
inserting ``the manufacturer affords such users
the opportunity''; and
(v) by striking ``the health care facility''.
(c) Title III; Additional Amendments.--
(1) Effective date.--Section 301(b) of Public Law 107-250
(116 Stat. 1616), is amended by striking ``18 months'' and
inserting ``36 months''.
(2) Premarket notification.--Section 510(o) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360(o)), as added by
section 302(b) of Public Law 107-250 (116 Stat. 1616), is
amended--
(A) in paragraph (1)(B), by striking ``,
adulterated'' and inserting ``or adulterated''; and
(B) in paragraph (2)--
(i) in subparagraph (B), by striking ``,
adulterated'' and inserting ``or adulterated'';
and
(ii) in subparagraph (E), by striking
``semicritical'' and inserting ``semi-
critical''.
(d) Miscellaneous Corrections.--
(1) Certain amendments to section 515.--
(A) In general.--
(i) Technical correction.--Section 515(c) of
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360e(c)), as amended by sections 209 and
302(c)(2)(A) of Public Law 107-250 (116 Stat.
1613, 1618), is amended by redesignating
paragraph (3) (as added by section 209 of such
Public Law) as paragraph (4).
(ii) Modular review.--Section 515(c)(4)(B) of
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360e(c)(4)(B)) is amended by striking
``unless an issue of safety'' and inserting
``unless a significant issue of safety''.
(B) Conforming amendment.--Section 210 of Public Law
107-250 (116 Stat. 1614) is amended by striking ``, as
amended'' and all that follows through ``by adding''
and inserting ``is amended in paragraph (3), as
redesignated by section 302(c)(2)(A) of this Act, by
adding''.
(2) Certain amendments to section 738.--
(A) In general.--Section 738(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j(a)), as amended
by subsection (a), is amended--
(i) in the matter preceding paragraph (1)--
(I) by striking ``(a) Types of
Fees.--Beginning on'' and inserting the
following:
``(a) Types of Fees.--
``(1) In general.--Beginning on''; and
(II) by striking ``this section as
follows:'' and inserting ``this
section.''; and
(ii) by striking ``(1) Premarket
application,'' and inserting the following:
``(2) Premarket application,''.
(B) Conforming amendments.--Section 738 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j),
as amended by subparagraph (A), is amended--
(i) in subsection (d)(1), in the last
sentence, by striking ``subsection (a)(1)(A)''
and inserting ``subsection (a)(2)(A)'';
(ii) in subsection (e)(1), by striking
``subsection (a)(1)(A)(vii)'' and inserting
``subsection (a)(2)(A)(vii)'';
(iii) in subsection (e)(2)(C)--
(I) in each of clauses (i) and (ii),
by striking ``subsection
(a)(1)(A)(vii)'' and inserting
``subsection (a)(2)(A)(vii)''; and
(II) in clause (ii), by striking
``subsection (a)(1)(A)(i)'' and
inserting ``subsection (a)(2)(A)(i)'';
and
(iv) in subsection (j), by striking
``subsection (a)(1)(D),'' and inserting
``subsection (a)(2)(D),''.
(C) Additional conforming amendment.--Section
102(b)(1) of Public Law 107-250 (116 Stat. 1600) is
amended, in the matter preceding subparagraph (A), by
striking ``section 738(a)(1)(A)(ii)'' and inserting
``section 738(a)(2)(A)(ii)''.
(3) Public law 107-250.--Public Law 107-250 is amended--
(A) in section 102(a) (116 Stat. 1589), by striking
``(21 U.S.C. 379F et seq.)'' and inserting ``(21 U.S.C.
379f et seq.)'';
(B) in section 102(b) (116 Stat. 1600)--
(i) by striking paragraph (2);
(ii) in paragraph (1), by redesignating
subparagraphs (A) and (B) as paragraphs (1) and
(2), respectively; and
(iii) by striking:
``(b) Fee Exemption for Certain Entities Submitting Premarket
Reports.--
``(1) In general.--A person submitting a premarket
report''and inserting:
``(b) Fee Exemption for Certain Entities Submitting Premarket
Reports.--A person submitting a premarket report''; and
(C) in section 212(b)(2) (116 Stat. 1614), by
striking ``, such as phase IV trials,''.
SEC. 3. REPORT ON BARRIERS TO AVAILABILITY OF DEVICES INTENDED FOR
CHILDREN.
Not later than 180 days after the date of enactment of this Act, the
Secretary of Health and Human Services shall submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives a report on the
barriers to the availability of devices intended for the treatment or
diagnosis of diseases and conditions that affect children. The report
shall include any recommendations of the Secretary of Health and Human
Services for changes to existing statutory authority, regulations, or
agency policy or practice to encourage the invention and development of
such devices.
Purpose and Summary
S. 1881 makes technical and conforming changes to the
Medical Device User Fee and Modernization Act of 2002.
Background and Need for Legislation
On October 26, 2002, President Bush signed into law the
Medical Device User Fee and Modernization Act of 2002 (P.L.
107-250). This legislation provided increased resources to the
Food and Drug Administration (FDA) through user fees and made
other significant reforms to the FDA in order to improve the
quality and speed of medical device approvals, but is in need
of technical corrections.
Hearings
The Committee on Energy and Commerce has not held hearings
on the legislation.
Committee Consideration
On March 3, 2004, the Full Committee met in open markup
session and favorably ordered S. 1881 reported to the House, as
amended, by a voice vote, a quorum being present.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto.
There were no record votes taken in connection with ordering S.
1881 reported. A motion by Mr. Barton to order S. 1881 reported
to the House, as amended, was agreed to by a voice vote.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee has not held oversight
or legislative hearings on this legislation.
Statement of General Performance Goals and Objectives
The goal of S. 1881 is to make technical and conforming
changes to the Medical Device User Fee and Modernization Act of
2002.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that S.
1881, the Medical Device Technical Corrections Act, would
result in no new or increased budget authority, entitlement
authority, or tax expenditures or revenues.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, March 8, 2004.
Hon. Joe Barton,
Chairman, Committee on Energy and Commerce, House of Representatives,
Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for S. 1881, the Medical
Devices Technical Corrections Act.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Julia
Christensen.
Sincerely,
Douglas Holtz-Eakin,
Director.
Enclosure.
S. 1881--Medical Devices Technical Corrections Act
S. 1881 would make technical changes regarding the Medical
Device User Fee and Modernization Act of 2002 (Public Law 107-
250). CBO estimates that enacting S. 1881 would have a
negligible impact on the Federal budget and have no effect on
direct spending or receipts.
The act would clarify the existing statute underlying the
Food and Drug Administration's (FDA's) user fee program for
medical devices. We anticipate that those modifications would
not significantly change the costs for FDA to administer the
program, nor would it affect user fee collections. S. 1881 also
would require the Secretary of Health and Human Services to
conduct a study on the availability of medical devices for
children. Assuming the availability of appropriated funds, CBO
estimates that implementing S. 1881 would cost less than
$500,000 a year.
This legislation contains no intergovernmental or private-
sector mandates as defined in the Unfunded Mandates Reform Act
and would impose no costs on State, local, or tribal
governments.
The CBO staff contact for this estimate is Julia
Christensen. This estimate was approved by Peter H. Fontaine,
Deputy Assistant Director for Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
Constitutional authority for this legislation is provided in
Article I, section 8, clause 3, which grants Congress the power
to regulate commerce with foreign nations, among the several
States, and with the Indian tribes.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 designates the short title as the ``Medical
Device Technical Corrections Act.''
Section 2. Technical amendments regarding Public Law 107-250
Section 2 makes several technical changes to the Medical
Device User Fee and Modernization Act of 2002 (P.L. 107-250).
It renumbers and conforms the appropriate sections of the
Federal Food, Drug, and Cosmetic Act, making grammatical
corrections, inserting periods, and correcting comma placement.
Section 2 clarifies the distinction between a ``panel track
supplement'' for which substantial clinical data is required to
demonstrate a reasonable assurance of safety and effectiveness
and a ``180-day supplement'' for which such data is not
required. Next, section 2 clarifies that premarket reports are
within the definition of ``process for the review of device
applications.'' Further, section 2 clarifies the term
``affiliate'' to include international as well as domestic
affiliates in the user fee program.
Section 2 makes technical changes clarifying that the third
party inspection program applies to 510(h) inspections of
establishments and inspections of foreign facilities required
to register with the Food and Drug Administration (FDA).
Section 2 ensures that facilities can work with third party
inspectors to allow them to complete a full 510(h) inspection
over the course of a two year period. Section 2 clarifies the
law and allows entities to certify that a foreign country
recognizes the third party conducting the inspection, instead
of requiring a statement that such a country recognizes FDA's
inspectional authority. Section 2 also ensures that companies
can use third party inspectors for two consecutive 510(h)
inspections before requesting special permission from the
Secretary for the third such inspection. Finally, section 2
makes important modifications to section 301 by providing an
18-month implementation delay for all branding requirements and
clarifies the definition of modular review to be consistent
with the FDA's modular review program.
Section 3. Report on barriers to availability of devices intended for
children
Section 3 requests that the FDA complete a report on the
barriers to the availability of devices intended for pediatric
patients, and provide policy recommendations as to what could
be changed in existing law to address this issue.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italics, existing law in which no change
is proposed is shown in roman):
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER III--PROHIBITED ACTS AND PENALTIES
PROHIBITED ACTS
Sec. 301. The following acts and the causing thereof are
hereby prohibited:
(a) * * *
* * * * * * *
[(gg) The knowing failure of a person accredited under
paragraph (2) of section 704(g) to comply with paragraph (7)(E)
of such section; the knowing inclusion by such a person of
false information in an inspection report under paragraph
(7)(A) of such section; or the knowing failure of such a person
to include material facts in such a report.]
(gg) The knowing failure to comply with paragraph (7)(E) of
section 704(g); the knowing inclusion by a person accredited
under paragraph (2) of such section of false information in an
inspection report under paragraph (7)(A) of such section; or
the knowing failure of such a person to include material facts
in such a report.
* * * * * * *
CHAPTER V--DRUGS AND DEVICES
Subchapter A--Drugs and Devices
Sec. 501. * * *
* * * * * * *
MISBRANDED DRUGS AND DEVICES
Sec. 502. A drug or device shall be deemed to be misbranded--
(a) * * *
* * * * * * *
(f) Unless its labeling bears (1) adequate directions for
use; and (2) such adequate warnings against use in those
pathological conditions or by children where its use may be
dangerous to health, or against unsafe dosage or methods or
duration of administration or application, in such manner and
form, as are necessary for the protection of users, except that
where any requirement of clause (1) of this paragraph, as
applied to any drug or device, is not necessary for the
protection of the public health, the Secretary shall promulgate
regulations exempting such drug or device from such
requirement. Required labeling for prescription devices
intended for use in health care facilities or by a health care
professional and required labeling for in vitro diagnostic
devices intended for use by health care professionals or in
blood establishments may be made available solely by electronic
means, provided that the labeling complies with all applicable
[requirements of law and, that] requirements of law, and that
[the manufacturer affords health care facilities the
opportunity] the manufacturer affords such users the
opportunity to request the labeling in paper form, and after
such request, promptly provides [the health care facility] the
requested information without additional cost.
* * * * * * *
REGISTRATION OF PRODUCERS OF DRUGS AND DEVICES
Sec. 510. (a) As used in this section--
(1) * * *
* * * * * * *
(o)(1) With respect to reprocessed single-use devices for
which reports are required under subsection (k):
(A) * * *
(B) In the case of each report under subsection (k)
that was submitted to the Secretary before the
publication of the initial list under subparagraph (A),
or any revision thereof, and was for a device or type
of device included on such list, the person who
submitted the report under subsection (k) shall submit
validation data as described in subparagraph (A) to the
Secretary not later than nine months after the
publication of the list. During such nine-month period,
the Secretary may not take any action under this Act
against such device solely on the basis that the
validation data for the device have not been submitted
to the Secretary. After the submission of the
validation data to the Secretary, the Secretary may not
determine that the device is misbranded under section
502(o)[, adulterated] or adulterated under section
501(f)(1)(B), or take action against the device under
section 301(p) for failure to provide any information
required by subsection (k) until (i) the review is
terminated by withdrawal of the submission of the
report under subsection (k); (ii) the Secretary finds
the data to be acceptable and issues a letter; or (iii)
the Secretary determines that the device is not
substantially equivalent to a predicate device. Upon a
determination that a device is not substantially
equivalent to a predicate device, or if such submission
is withdrawn, the device can no longer be legally
marketed.
* * * * * * *
(2) With respect to critical or semi-critical reprocessed
single-use devices that, under subsection (l) or (m), are
exempt from the requirement of submitting reports under
subsection (k):
(A) * * *
(B) For each device or type of device included on the
list under subparagraph (A), a report under subsection
(k) shall be submitted to the Secretary not later than
15 months after the publication of the initial list, or
a revision of the list, whichever terminates the
exemption for the device. During such 15-month period,
the Secretary may not take any action under this Act
against such device solely on the basis that such
report has not been submitted to the Secretary. After
the submission of the report to the Secretary the
Secretary may not determine that the device is
misbranded under section 502(o)[, adulterated] or
adulterated under section 501(f)(1)(B), or take action
against the device under section 301(p) for failure to
provide any information required by subsection (k)
until (i) the review is terminated by withdrawal of the
submission; (ii) the Secretary determines by order that
the device is substantially equivalent to a predicate
device; or (iii) the Secretary determines by order that
the device is not substantially equivalent to a
predicate device. Upon a determination that a device is
not substantially equivalent to a predicate device, the
device can no longer be legally marketed.
* * * * * * *
(E) The termination under subparagraph (A) of an
exemption under subsection (l) or (m) for a critical or
[semicritical] semi-critical reprocessed single-use
device does not terminate the exemption under
subsection (l) or (m) for the original device.
* * * * * * *
PREMARKET APPROVAL
General Requirement
Sec. 515. (a) * * *
* * * * * * *
Application for Premarket Approval
(c)(1) * * *
* * * * * * *
[(3)] (4)(A) Prior to the submission of an application under
this subsection, the Secretary shall accept and review any
portion of the application that the applicant and the Secretary
agree is complete, ready, and appropriate for review, except
that such requirement does not apply, and the Secretary has
discretion whether to accept and review such portion, during
any period in which, under section 738(g), the Secretary does
not have the authority to collect fees under section 738(a).
(B) Each portion of a submission reviewed under subparagraph
(A) and found acceptable by the Secretary shall not be further
reviewed after receipt of an application that satisfies the
requirements of paragraph (1), [unless an issue of safety]
unless a significant issue of safety or effectiveness provides
the Secretary reason to review such accepted portion.
(C) Whenever the Secretary determines that a portion of a
submission under subparagraph (A) is unacceptable, the
Secretary shall, in writing, provide to the applicant a
description of any deficiencies in such portion and identify
the information that is required to correct these deficiencies,
unless the applicant is no longer pursuing the application.''.
* * * * * * *
CHAPTER VII--GENERAL AUTHORITY
Subchapter A--General Administrative Provisions
* * * * * * *
FACTORY INSPECTION
Sec. 704. (a)(1) * * *
* * * * * * *
(g)(1) Not later than one year after the date of the
enactment of this subsection, the Secretary shall, subject to
the provisions of this subsection, accredit persons for the
purpose of [conducting inspections of establishments that
manufacture, prepare, propagate, compound, or process class II
or class III devices that are required in section 510(h), or
inspections of such establishments required to register
pursuant to section 510(i).] conducting inspections of
establishments that manufacture, prepare, propagate, compound,
or process class II or class III devices, which inspections are
required under section 510(h) or are inspections of such
establishments required to register under section 510(i). The
owner or operator of such an establishment that is eligible
under paragraph (6) may, from the list published under
paragraph (4), select an accredited person to conduct such
inspections.
* * * * * * *
(5)(A) * * *
(B) The Secretary may withdraw accreditation of any person
accredited under paragraph (2), after providing notice and an
opportunity for an informal hearing, when such person is
substantially not in compliance with the standards of
accreditation, [or poses a threat to public health or fails to
act in a manner that is consistent with the purposes of this
subsection.] poses a threat to public health, fails to act in a
manner that is consistent with the purposes of this subsection,
or where the Secretary determines that there is a financial
conflict of interest in the relationship between the accredited
person and the owner or operator of a device establishment that
the accredited person has inspected under this subsection. The
Secretary may suspend the accreditation of such person during
the pendency of the process under the preceding sentence.
(6)(A) Subject to subparagraphs (B) and (C), a device
establishment is eligible for inspections by persons accredited
under paragraph (2) if the following conditions are met:
(i) The Secretary classified the results of the most
recent inspection [of the establishment pursuant to
subsection (h) or (i) of section 510] described in
paragraph (1) as ``no action indicated'' or ``voluntary
action indicated''.
(ii) With respect to [each inspection] inspections to
be conducted by an accredited person during a 2-year
period--
(I) the owner or operator of the
establishment submits to the Secretary a notice
requesting clearance to use [such a person] an
accredited person to conduct the inspection,
and the Secretary provides such clearance; and
* * * * * * *
(iii) With respect to the devices that are
manufactured, prepared, propagated, compounded, or
processed by the establishment, at least one of such
devices is marketed in the United States, [and the
following additional conditions are met:] and 1 or both
of the following additional conditions are met:
(I) At least one of such devices is marketed,
or is intended to be marketed, in one or more
foreign countries, one of which countries
certifies, accredits, or otherwise recognizes
the person [accredited under paragraph (2) and
identified under subclause (II) of this
clause.] (accredited under paragraph (2) and
identified under clause (ii)(II)) as a person
authorized to conduct such inspections of
device establishments.
(II) The owner or operator of the
establishment submits to the Secretary a
statement that the law of a country in which
such a device is marketed, or is intended to be
marketed, recognizes an inspection of the
establishment by the Secretary or by a person
accredited under paragraph (2), and not later
than 30 days after receiving such statement,
the Secretary informs the owner or operator of
the establishment that the owner or operator
may submit a notice requesting clearance under
clause (ii).
(iv)(I) In the case of an inspection to be conducted
pursuant to section 510(h), persons accredited under
paragraph (2) did not conduct [the two immediately
preceding inspections of the establishment] inspections
of the establishment during the previous 4 years,
except that the establishment may petition the
Secretary for a waiver of such condition. Such a waiver
may be granted only if the petition states a commercial
reason for the waiver; the Secretary determines that
the public health would be served by granting the
waiver; and the Secretary has conducted an inspection
of the establishment during the four-year period
preceding the date on which the notice under clause
(ii) is submitted to the Secretary. Such a waiver is
deemed to be granted only if [the petition states a
commercial reason for the waiver;] the Secretary has
not determined that the public health would not be
served by granting the waiver; and the owner or
operator of the device establishment has requested in
writing, not later than 18 months following the most
recent inspection of such establishment by a person
accredited under paragraph (2), that the Secretary
inspect the establishment and the Secretary has not
conducted an inspection within 30 months after the most
recent inspection. With respect to such a waiver that
is granted or deemed to be granted, no additional such
waiver may be [granted until] granted or deemed to be
granted until after the Secretary has conducted an
inspection of the establishment.
(II) In the case of an inspection to be conducted of
a device establishment required to register pursuant to
section 510(i), the Secretary periodically conducts
inspections of the establishment.
* * * * * * *
(B)(i) * * *
* * * * * * *
(iii) The compliance data to be submitted by a device
establishment under clause (ii) are data describing whether the
quality controls of the establishment have been sufficient for
ensuring consistent compliance with current good manufacturing
practice within the meaning of section 501(h)[, and data
otherwise describing whether the establishment has consistently
been in compliance with sections 501 and 502 and other] and
with other applicable provisions of this Act. Such data shall
include complete reports of [inspections] inspectional findings
regarding good manufacturing practice or other quality control
audits that, during the preceding two-year period, were
conducted at the establishment by persons other than the owner
or operator of the establishment, together with all other
relevant compliance data the Secretary deems necessary. Data
under the preceding sentence shall demonstrate to the Secretary
whether the establishment has facilitated consistent compliance
by promptly correcting any compliance problems identified in
such inspections.
(iv)(I) Not later than 60 days after receiving compliance
data under clause (iii) from a device establishment, the
Secretary shall provide or deny clearance under subparagraph
(A). The Secretary may deny clearance if the Secretary
determines that the establishment has failed to demonstrate
consistent compliance for purposes of clause (iii). The
Secretary shall provide to the establishment a statement of
such reasons for such determination. If the Secretary fails to
provide such statement to the establishment within such 60-day
period, the establishment is deemed to have such clearance.
(II) If, during the two-year period following clearance under
subparagraph (A), the Secretary determines that the device
establishment is substantially not in compliance with this Act,
the Secretary may, after notice and a written response, notify
the establishment that the eligibility of the establishment for
the inspections by accredited persons has been suspended.
* * * * * * *
(C)(i) * * *
(ii) If the Secretary denies a petition under clause (i), the
device establishment involved may, after the expiration of one
year after such denial, again petition the Secretary for a
determination of eligibility for inspection by persons
accredited by the Secretary under paragraph (2). If the
Secretary denies such petition, the Secretary shall provide the
establishment with such reasons for such denial within 60 days
after the denial. If, as of the expiration of 48 months after
the receipt of the first petition, the establishment has not
been inspected by the Secretary [in accordance with section
510(h), or has not during such period been inspected pursuant
to section 510(i), as applicable], the establishment is
eligible for further inspections by accredited persons.
* * * * * * *
(10)(A) * * *
(B)(i) * * *
* * * * * * *
(iii) Not later than March 31, 2003, the Comptroller General
shall complete the determinations required in this subparagraph
and submit to the Secretary and the Congress [a reporting] a
report describing the findings made through such
determinations.
* * * * * * *
(12) No later than four years after the enactment of this
subsection the Comptroller General shall report to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor
and Pensions of the Senate--
[(A) the number of inspections pursuant to
subsections (h) and (i) of section 510 conducted by
accredited persons and the number of inspections
pursuant to such subsections conducted by Federal
employees;]
(A) the number of inspections conducted by accredited
persons pursuant to this subsection and the number of
inspections conducted by Federal employees pursuant to
section 510(h) and of device establishments required to
register under section 510(i);
* * * * * * *
(E) whether this subsection is achieving the goal of
ensuring more information about device establishment
compliance is being presented to the Secretary, and
whether that information is of a quality consistent
with information [obtained by the Secretary pursuant to
subsection (h) or (i) of section 510;] obtained by the
Secretary pursuant to inspections conducted by Federal
employees;
* * * * * * *
Subchapter C--Fees
* * * * * * *
PART 3--FEES RELATING TO DEVICES
SEC. 737. DEFINITIONS.
For purposes of this subchapter:
(1) * * *
* * * * * * *
(4)(A) * * *
(B) The term ``panel-track supplement'' means a
supplement to an approved premarket application or
premarket report under section 515 that requests a
significant change in design or performance of the
device, or a new indication for use of the device, [and
for which clinical data are generally necessary to
provide a reasonable assurance of safety and
effectiveness] and for which substantial clinical data
are necessary to provide a reasonable assurance of
safety and effectiveness.
* * * * * * *
(D) The term ``real-time supplement'' means a
supplement to an approved premarket application or
premarket report under section 515 that requests a
minor change to the device, such as a minor change to
the design of the device, software, [manufacturing,]
sterilization, or labeling, and for which the applicant
has requested and the agency has granted a meeting or
similar forum to jointly review and determine the
status of the supplement.
* * * * * * *
(5) The term ``process for the review of device
applications'' means the following activities of the
Secretary with respect to the review of premarket
applications, premarket reports, supplements, and
premarket notification submissions:
(A) * * *
* * * * * * *
(J) Evaluation of postmarket studies required
as a condition of an approval of [a premarket
application under section 515 or section 351 of
the Public Health Service Act.] a premarket
application or premarket report under section
515 or a premarket application under section
351 of the Public Health Service Act.
* * * * * * *
(8) [The term ``affiliate'' means a business entity
that has a relationship with a second business entity]
The term `affiliate' means a business entity that has a
relationship with a second business entity (whether
domestic or international) if, directly or indirectly--
(A) * * *
* * * * * * *
SEC. 738. AUTHORITY TO ASSESS AND USE DEVICE FEES.
[(a) Types of Fees.--Beginning on] (a) Types of Fees.--
(1) In general.--Beginning on the date of the
enactment of the Medical Device User Fee and
Modernization Act of 2002, the Secretary shall assess
and collect fees in accordance with [this section as
follows:] this section.
[(1) Premarket application,] (2) Premarket
application, premarket report, supplement, and
submission fee.--
(A) In general.--Except as provided in
subparagraph (B) and [subsection (d),]
subsections (d) and (e), each person who
submits any of the following, on or after
October 1, 2002, shall be subject to a fee
established under subsection (c)(5) for the
fiscal year involved in accordance with the
following:
(i) * * *
* * * * * * *
(iv) For a 180-day supplement, a fee
equal to 21.5 percent of the fee that
applies under [clause (i), subject to
any adjustment under subsection
(c)(3).] clause (i).
* * * * * * *
(vii) For a premarket notification
submission, a fee equal to 1.42 percent
of the fee that applies under [clause
(i), subject to any adjustment under
subsection (c)(3) and any adjustment
under subsection (e)(2)(C)(ii).] clause
(i), subject to any adjustment under
subsection (e)(2)(C)(ii).
* * * * * * *
(D) Refunds.--
(i) Application refused for filing.--
The Secretary shall refund 75 percent
of the fee paid under subparagraph (A)
for any [application] application,
report, or supplement that is refused
for filing.
(ii) Application withdrawn before
filing.--The Secretary shall refund 75
percent of the fee paid under
subparagraph (A) for any [application]
application, report, or supplement that
is withdrawn prior to the filing
decision of the Secretary.
* * * * * * *
(d) Small Businesses; Fee Waiver and Fee Reduction Regarding
Premarket Approval Fees.--
(1) In general.--The Secretary shall grant a waiver
of the fee required under subsection (a) for one
premarket application, or one premarket report, where
the Secretary finds that the applicant involved is a
small business submitting its first premarket
application to the Secretary, or its first premarket
report, respectively, for review. In addition, for
subsequent premarket applications, premarket reports,
and supplements where the Secretary finds that the
applicant involved is a small business, the fees
specified in clauses (i) through (vi) of [subsection
(a)(1)(A)] subsection (a)(2)(A) may be paid at a
reduced rate in accordance with paragraph (2)(C).
(2) Rules relating to premarket approval fees.--
(A) * * *
(B) Evidence of qualification.--An applicant
shall pay the higher fees established by the
Secretary each year unless the applicant
submits evidence that it qualifies for a waiver
of the fee or the lower fee rate. The applicant
shall support its claim that it meets the
definition under subparagraph (A) by submission
of a copy of its most recent Federal income tax
return for a taxable year, and a copy of such
returns of its affiliates, partners, and parent
[firms. which show] firms, which show an amount
of gross sales or receipts that is less than
the maximum established in subparagraph (A).
The applicant, and each of such affiliates,
partners, and parent firms, shall certify that
the information provided is a true and accurate
copy of the actual tax forms they submitted to
the Internal Revenue Service. If no tax forms
are submitted for affiliates, partners, or
parent firms, the applicant shall certify that
the applicant has no affiliates, partners, or
parent firms, respectively.
* * * * * * *
(e) Small Businesses; Fee Reduction Regarding Premarket
Notification Submissions.--
(1) In general.--[Where] For fiscal year 2004 and
each subsequent fiscal year, where the Secretary finds
that the applicant involved is a small business, the
fee specified in [subsection (a)(1)(A)(vii)] subsection
(a)(2)(A)(vii) may be paid at a reduced rate in
accordance with paragraph (2)(C).
(2) Rules relating to premarket notification
submissions.--
(A) * * *
(B) Evidence of qualification.--An applicant
shall pay the higher fees established by the
Secretary each year unless the applicant
submits evidence that it qualifies for the
lower fee rate. The applicant shall support its
claim that it meets the definition under
subparagraph (A) by submission of a copy of its
most recent Federal income tax return for a
taxable year, and a copy of such returns of its
affiliates, partners, and parent [firms. which
show] firms, which show an amount of gross
sales or receipts that is less than the maximum
established in subparagraph (A). The applicant,
and each of such affiliates, partners, and
parent firms, shall certify that the
information provided is a true and accurate
copy of the actual tax forms they submitted to
the Internal Revenue Service. If no tax forms
are submitted for affiliates, partners, or
parent firms, the applicant shall certify that
the applicant has no affiliates, partners, or
parent firms, respectively.
(C) Reduced fees.--
(i) In general.--[Where] For fiscal
year 2004 and each subsequent fiscal
year, where the Secretary finds that
the applicant involved meets the
definition under subparagraph (A), the
fee for a premarket notification
submission may be paid at 80 percent of
the fee that applies under [subsection
(a)(1)(A)(vii)] subsection
(a)(2)(A)(vii), as adjusted under
clause (ii) and as established under
subsection (c)(5).
(ii) Adjustment per fee revenue
amount.--For fiscal year 2004 and each
subsequent fiscal year, the Secretary,
in setting the revenue amount under
subsection (c)(5) for premarket
notification submissions, shall
determine the revenue amount that would
apply if all such submissions for the
fiscal year involved paid a fee equal
to 1.42 percent of the amount that
applies under [subsection (a)(1)(A)(i)]
subsection (a)(2)(A)(i) for premarket
applications, and shall adjust the fee
under [subsection (a)(1)(A)(vii)]
subsection (a)(2)(A)(vii) for premarket
notification submissions such that the
reduced fees collected under clause (i)
of this subparagraph, when added to
fees for such submissions that are not
paid at the reduced rate, will equal
such revenue amount for the fiscal
year.
* * * * * * *
(f) Effect of Failure to Pay Fees.--A premarket application,
premarket report, supplement, or premarket notification
submission submitted by a person subject to fees under
subsection (a) shall be considered incomplete and shall not be
accepted [for filing] by the Secretary until all fees owed by
such person have been paid.
* * * * * * *
(h) Crediting and Availability of Fees.--
(1) * * *
(2) Collections and appropriation acts.--
(A) * * *
(B) Compliance.--[The Secretary]
(i) In general.--The Secretary shall
be considered to have met the
requirements of subparagraph (A)(ii) in
any fiscal year if the costs funded by
appropriations and allocated for the
process for the review of device
applications--
[(i)] (I) are not more than 3 percent
below the level specified in
subparagraph (A)(ii); or
[(ii)(I)] (II)(aa) are more than 3
percent below the level specified in
subparagraph (A)(ii), and fees assessed
for a subsequent fiscal year are
decreased by the amount in excess of 3
percent by which such costs fell below
the level specified in such
subparagraph; and
[(II)] (bb) such costs are not more
than 5 percent below the level
specified in such subparagraph.
(ii) More than 5 percent.--To the
extent such costs are more than 5
percent below the specified level in
subparagraph (A)(ii), fees may not be
collected under this section for that
fiscal year.
* * * * * * *
(j) Written Requests for Refunds.--To qualify for
consideration for a refund under [subsection (a)(1)(D),]
subsection (a)(2)(D), a person shall submit to the Secretary a
written request for such refund not later than 180 days after
such fee is due.
* * * * * * *
----------
MEDICAL DEVICE USER FEE AND MODERNIZATION ACT OF 2002
(Public Law 107-250)
* * * * * * *
TITLE I--FEES RELATED TO MEDICAL DEVICES
* * * * * * *
SEC. 102. ESTABLISHMENT OF PROGRAM.
(a) In General.--Subchapter C of chapter VII of the Federal
Food, Drug, and Cosmetic Act [(21 U.S.C. 379F et seq.)] (21
U.S.C. 379f et seq.) is amended by adding at the end the
following part:
* * * * * * *
[(b) Fee Exemption for Certain Entities Submitting Premarket
Reports.--
(1) In general.--A person submitting a premarket
report]
(b) Fee Exemption for Certain Entities Submitting Premarket
Reports.--A person submitting a premarket report to the
Secretary of Health and Human Services is exempt from the fee
under [section 738(a)(1)(A)(ii)] section 738(a)(2)(A)(ii) of
the Federal Food, Drug, and Cosmetic Act (as added by
subsection (a) of this section) if--
[(A)] (1) the premarket report is the first
such report submitted to the Secretary by the
person; and
[(B)] (2) before October 1, 2002, the person
submitted a premarket application to the
Secretary for the same device as the device for
which the person is submitting the premarket
report.
[(2) Definitions.--For purposes of paragraph (1), the
terms ``device'', ``premarket application'', and
``premarket report'' have the same meanings as apply to
such terms for purposes of section 738 of the Federal
Food, Drug, and Cosmetic Act (as added by subsection
(a) of this section).]
* * * * * * *
TITLE II--AMENDMENTS REGARDING REGULATION OF MEDICAL DEVICES
* * * * * * *
SEC. 210. PEDIATRIC EXPERTISE REGARDING CLASSIFICATION-PANEL REVIEW OF
PREMARKET APPLICATIONS.
Section 515(c) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360e(c))[, as amended by section 302(c)(2)(A) of
this Act, is amended in paragraph (3) by adding] is amended in
paragraph (3), as redesignated by section 302(c)(2)(A) of this
Act, by adding at the end the following: ``Where appropriate,
the Secretary shall ensure that such panel includes, or
consults with, one or more pediatric experts.''.
* * * * * * *
SEC. 212. STUDY BY INSTITUTE OF MEDICINE OF POSTMARKET SURVEILLANCE
REGARDING PEDIATRIC POPULATIONS.
(a) * * *
(b) Certain Matters.--The Secretary shall ensure that
determinations made in the study under subsection (a) include
determinations of--
(1) * * *
(2) whether the postmarket surveillance by the Food
and Drug Administration of medical devices used in
pediatric populations is sufficient to provide adequate
safeguards for such populations, taking into account
the Secretary's monitoring of commitments made at the
time of approval of medical devices[, such as phase IV
trials,] and the Secretary's monitoring and use of
adverse reaction reports, registries, and other
postmarket surveillance activities.
* * * * * * *
TITLE III--ADDITIONAL AMENDMENTS
SEC. 301. IDENTIFICATION OF MANUFACTURER OF MEDICAL DEVICES.
(a) * * *
(b) Effective Date.--The amendment made by subsection (a)
takes effect [18 months] 36 months after the date of the
enactment of this Act, and only applies to devices introduced
or delivered for introduction into interstate commerce after
such effective date.
* * * * * * *