Medical Devices Technical Corrections Act - Amends the Federal Food, Drug, and Cosmetic Act (as amended by the Medical Device User Fee and Modernization Act of 2002) to revise provisions concerning medical devices user fees.
Prohibits the Secretary of Health and Human Services from collecting fees to defray costs in any fiscal year where the amount appropriated is more than five percent below the costs of the resources allocated for the review of device applications.
Allows the Secretary to withdraw the accreditation to inspect from any person where the Secretary has information indicating a relationship between the company and the accredited inspector that may create a conflict of interest.
Permits a company that markets at least one medical device in the United States and one medical device in another country to use an accredited third party inspector if the company certifies that the foreign country recognizes inspections by: (1) the Food and Drug Administration (FDA); and/or (2) the third party inspector. (Current law requires a country to recognize both types of inspections.)
Allows the Secretary to withdraw eligibility for third party inspections from a company if the Secretary obtains information indicating significant deviations from compliance with the Act or implementing regulations.
Allows electronic labeling for prescription devices intended for use by health care professionals and for in vitro diagnostic devices intended for use by health care professionals or in blood establishments.
Delays by 18 additional months the effective date of the provision deeming a device misbranded if the identification of the manufacturer is not conspicuously displayed.
Directs the Secretary to submit a report to the relevant committees on the barriers to the availability of devices intended for treatment or diagnosis of diseases or conditions that affect children.
[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3493 Introduced in House (IH)]
108th CONGRESS
1st Session
H. R. 3493
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.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
November 17, 2003
Mr. Greenwood (for himself and Ms. Eshoo) 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 make technical
corrections relating to the amendments made by the Medical Device User
Fee and Modernization Act of 2002, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Medical Devices Technical
Corrections Act of 2003''.
SEC. 2. TECHNICAL CORRECTIONS REGARDING PUBLIC LAW 107-250.
(a) Title I; Fees Relating to Medical Devices.--
(1) Types of fees.--Section 738 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j), as added by section 102 of
Public Law 107-250 (116 Stat. 1589), is amended by amending
subsection (a) to read as follows:
``(a) Types of Fees.--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:
``(1) Premarket application, premarket report, supplement,
and submission fee.--Except as provided in paragraph (2) and
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:
``(A) A premarket application.
``(B) For a premarket report, a fee equal to the
fee that applies under subparagraph (A).
``(C) For a panel track supplement, a fee equal to
the fee that applies under subparagraph (A).
``(D) For a 180-day supplement, a fee equal to 21.5
percent of the fee that applies under subparagraph (A).
``(E) For a real-time supplement, a fee equal to
7.2 percent of the fee that applies under subparagraph
(A).
``(F) For an efficacy supplement, a fee equal to
the fee that applies under subparagraph (A).
``(G) For a premarket notification submission, a
fee equal to 1.42 percent of the fee that applies under
subparagraph (A), subject to any adjustment under
subsection (e)(2)(C)(ii).
``(2) Exceptions.--
``(A) Humanitarian device exemption.--An
application under section 520(m) is not subject to any
fee under paragraph (1).
``(B) Further manufacturing use.--No fee shall be
required under paragraph (1) for the submission of a
premarket application under section 351 of the Public
Health Service Act for a product licensed for further
manufacturing use only.
``(C) State or federal government sponsors.--No fee
shall be required under paragraph (1) for a premarket
application, premarket report, supplement, or premarket
notification submission submitted by a State or Federal
Government entity unless the device involved is to be
distributed commercially.
``(D) Premarket notifications by third parties.--No
fee shall be required under paragraph (1) for a
premarket notification submission reviewed by an
accredited person pursuant to section 523.
``(E) Pediatric conditions of use.--
``(i) In general.--No fee shall be required
under paragraph (1) for a premarket
application, premarket report, or premarket
notification submission if the proposed
conditions of use for the device involved are
solely for a pediatric population. No fee shall
be required under such subparagraph for a
supplement if the sole purpose of the
supplement is to propose conditions of use for
a pediatric population.
``(ii) Subsequent proposal of adult
conditions of use.--In the case of a person who
submits a premarket application or premarket
report for which, under clause (i), a fee under
paragraph (1) is not required, any supplement
to such application that proposes conditions of
use for any adult population is subject to the
fee that applies under such subparagraph for a
premarket application.
``(3) Payment.--The fee required by paragraph (1) shall be
due upon submission of the premarket application, premarket
report, supplement, or premarket notification submission,
except that invoices for applications submitted on or after
October 1, 2002, and before the date on which appropriations
under subsection (h)(3) for fiscal year 2003 first become
available shall be payable within 30 days of the issuance of
such invoices. Applicants submitting portions of applications
pursuant to section 515(c)(3) shall pay such fees upon
submission of the first portion of such applications. The fees
credited to fiscal year 2003 under this section shall include
all fees payable from October 1, 2002, through September 30, 2003.
``(4) Refunds.--
``(A) Application refused for filing.--The
Secretary shall refund 75 percent of the fee paid under
paragraph (1) for any application, report, or
supplement that is refused for filing.
``(B) Application withdrawn before filing.--The
Secretary shall refund 75 percent of the fee paid under
paragraph (1) for any application, report, or
supplement that is withdrawn prior to the filing
decision of the Secretary.
``(C) Application withdrawn before first action.--
After receipt of a request for a refund of the fee paid
under paragraph (1) for a premarket application,
premarket report, or supplement that is withdrawn after
filing but before a first action, the Secretary may
return some or all of the fee. The amount of refund, if
any, shall be based on the level of effort already
expended on the review of such application, report, or
supplement. The Secretary shall have sole discretion to
refund a fee or portion of the fee under this
subparagraph. A determination by the Secretary
concerning a refund under this paragraph shall not be
reviewable.''.
(2) Other corrections relating to fees.--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--
(A) in section 737--
(i) in paragraph (4)--
(I) in subparagraph (B), by
striking ``and for which'' and all that
follows and inserting the following:
``and for which substantial clinical
data are necessary to provide a
reasonable assurance of safety and
effectiveness.''; and
(II) in subparagraph (D), by
striking ``manufacturing,'';
(ii) in paragraph (5)(J), by striking ``a
premarket application'' and all that follows
and inserting the following: ``a premarket
application or premarket report under section
515 or a premarket application under section
351 of the Public Health Service Act.''; and
(iii) in paragraph (8), in the matter
preceding subparagraph (A), by inserting
``(whether domestic or international)'' after
``second business entity''; and
(B) in section 738--
(i) in subsection (d)(2)(B), beginning in
the second sentence, by striking ``firms. which
show'' and inserting ``firms, which show'';
(ii) 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)--
(aa) in subparagraph (B),
beginning in the second
sentence, by striking ``firms.
which show'' and inserting
``firms, which show''; and
(bb) in subparagraph
(C)(i), by striking ``Where''
and inserting ``For fiscal year
2004 and each subsequent fiscal
year, where'';
(iii) in subsection (f), by striking ``for
filing'' and inserting ``for review''; and
(iv) in subsection (h)(2)--
(I) in subparagraph (A), by
striking clause (ii) and inserting the
following:
``(ii) shall only be collected and
available to defray increases in the costs of
the resources allocated for the purposes for
the review of device applications (including
increases in such costs for an additional
number of full-time equivalent positions in the
Department of Health and Human Services to be
engaged in such process) over such costs for
fiscal year 2002 when multiplied by the
adjustment factor.
For purposes of this subparagraph, the determination of
the costs of the resources allocated for the process
for the review of device applications for fiscal year
2003 through 2007 shall not include costs paid from
fees collected under this section.''; and
(II) in subparagraph (B), by
inserting after and below clause
(ii)((II) the following:
``To the extent such costs are more than 5 percent
below the level specified 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 the following: ``conducting
inspections of establishments that manufacture,
prepare, propagate, compound, or process class II or
class III devices, which inspections are required in
section 510(h) or are inspections of such
establishments required to register under section
510(i).'';
(B) in paragraph (6)(A)--
(i) in the matter preceding clause (i), by
inserting ``during a two-year period'' after
``paragraph (2)'';
(ii) in clause (i), by striking ``most
recent inspection'' and all that follows
through ``section 510 as'' and inserting ``most
recent inspection described in paragraph (1)
as'';
(iii) in clause (ii)--
(I) in the matter preceding
subclause (I), by striking ``With
respect to'' and all that follows and
inserting the following: ``With respect
to the inspections to be conducted by
an accredited person during such two-
year period--'';
(II) in subclause (I), by striking
``such a person to conduct the
inspection,'' and inserting ``an
accredited person to conduct the
inspections,''; and
(III) in subclause (II), by
striking ``the inspection,'' and
inserting ``the inspections,'';
(iv) in clause (iii)--
(I) in the matter preceding
subclause (I), by striking ``United
States,'' and all that follows and
inserting ``United States, and--'';
(II) in subclause (I)--
(aa) by striking ``At least
one'' and inserting ``at least
one''; and
(bb) by striking
``identified under subclause
(II) of this clause.'' and
inserting ``identified under
clause (ii)(II); or''; and
(III) in subclause (II), by
striking ``The owner'' and inserting
``the owner''; and
(v) in clause (iv)--
(I) in subclause (I), in the first
sentence, by striking ``In the case
of'' and all that follows through
``except that'' and inserting the
following: ``In the case of inspections
to be conducted pursuant to section
510(h), persons accredited under
paragraph (2) did not conduct any
inspection of the establishment during
the two preceding two-year periods
referred to in such section with
respect to the establishment, except
that'';
(II) in subclause (II), by striking ``In
the case of'' and all that follows through
``the Secretary'' and inserting the following:
``In the case of inspections to be conducted of
a device establishment required to register
under section 510(i), the Secretary'';
(C) in paragraph (6)(B)--
(i) in clause (iii)--
(I) by striking ``and data
otherwise'' in the first sentence and
all that follows through ``reports of
inspections regarding'' in the second
sentence and inserting the following:
``and data describing compliance with
other applicable provisions of this
Act. Such data shall include reports of
inspectional findings regarding''; and
(II) in the second sentence, by
striking ``establishment, together
with'' and all that follows and
inserting ``establishment.''; and
(ii) in clause (v), by adding at the end
the following subclause:
``(III) The agreement (or deemed agreement) of the
Secretary under this subparagraph to the selection of an
accredited person is effective for the two-year period referred
to in the matter preceding clause (i) of subparagraph (A),
subject to paragraph (5)(B).'';
(D) in paragraph (6)(C)(ii), in the last sentence,
by inserting before the period the following: ``and may
submit a notice under subparagraph (A)'';
(E) in paragraph (10)(B)(iii), by striking ``a
reporting'' and inserting ``a report''; and
(F) in paragraph (12)--
(i) in subparagraph (A), by striking ``the
number of'' the first place such term appears
and all that follows and inserting the
following: ``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.--Chapter V of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.), as amended by
sections 204 and 206 of Public Law 107-250 (116 Stat. 1611,
1613), is amended--
(A) in section 502(f), in the last sentence--
(i) by striking ``requirements of law and,
that'' and inserting ``requirements of law,
that''; and
(ii) by striking ``and after such request,
promptly provides'' and inserting ``and that,
after receiving such request, the manufacturer
promptly provides''; and
(B) in section 503(g)(4)(A), in the second
sentence, by striking ``shall, in determining whether''
and all that follows through ``consult'' and inserting
the following: ``shall, in determining whether the
product to be assigned is appropriately classified as a
combination product, consult''.
(c) Title III; Additional Amendments.--
(1) In general.--The Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.), as amended by sections 301 and 302 of
Public Law 107-250 (116 Stat. 1616), is amended--
(A) in section 502 (21 U.S.C. 352)--
(i) by striking paragraph (u); and
(ii) by redesignating paragraph (v) as
paragraph (u); and
(B) in section 510(o) (21 U.S.C. 360(o))--
(i) in paragraph (1)(B), in the third
sentence, by striking ``misbranded under
section 502(o), adulterated under'' and
inserting ``misbranded under section 502(o) or
adulterated under''; and
(ii) in paragraph (2)--
(I) in subparagraph (B), in the
third sentence, by striking
``misbranded under section 502(o),
adulterated under'' and inserting
``misbranded under section 502(o) or
adulterated under''; and
(II) in subparagraph (E), by
striking ``semicritical'' and inserting
``semi-critical''.
(2) Conforming amendment.--Section 301 of Public Law 107-
250 (116 Stat. 1616) is amended by striking subsection (b).
(d) Miscellaneous Corrections.--
(1) Certain amendments regarding section 515(c).--
(A) In general.--Section 515(c) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360e), as
amended by sections 209 and 302(c)(2)(A) of Public Law
107-250 (116 Stat. 1613, 1618), is amended--
(i) by redesignating the second paragraph
(3) (added by section 209 of such Public Law)
as paragraph (4); and
(ii) in paragraph (4) (as so redesignated),
in subparagraph (B), by striking ``an issue''
and inserting ``a new issue''.
(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 the following: ``is amended in paragraph
(3), as redesignated by section 302(c)(2)(A) of this
Act, by adding''.
(2) Conforming amendments regarding references to section
738(a).--
(A) In general.--Section 738 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j), as amended by
subparagraph (A) of this paragraph, is amended--
(i) in subsection (d)(1), in the last
sentence, by striking ``clauses (i) through
(vi) of subsection (a)(1)(A)'' and inserting
``subparagraphs (A) through (F) of subsection
(a)(1)'';
(ii) in subsection (e)(1), by striking
``subsection (a)(1)(A)(vii)'' and inserting
``subsection (a)(1)(G)'';
(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)(1)(G)''; and
(II) in clause (ii), by striking
``subsection (a)(1)(A)(i)'' and
inserting ``subsection (a)(1)(A)''; and
(iv) in subsection (j), by striking
``subsection (a)(1)(D),'' and inserting
``subsection (a)(4),''.
(B) 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)(1)(B)''.
(3) Public law 107-250.--Public Law 107-250 is amended--
(A) in section 102--
(i) in subsection (a) (116 Stat. 1589), by
striking ``(21 U.S.C. 379F et seq.)'' and
inserting ``(21 U.S.C. 379f et seq.)''; and
(ii) in subsection (b) (116 Stat. 1600), by
striking paragraph (2);
(B) in section 212(b)(2) (116 Stat. 1614), by
striking ``medical devices, such as phase IV trials,
and'' and inserting ``medical devices and''; and
(C) in section 214(a)(3) (116 Stat. 1615), by
striking ``discussion'' and inserting ``presentation''.
(4) Public health service act.--Section 498C of the Public
Health Service Act (42 U.S.C. 289g-3), as added by section
215(b) of Public Law 107-250 (116 Stat. 1615), is amended in
subsection (a) by striking ``Director of NIH may'' and
inserting ``Director of NIH shall''.
(e) Humanitarian Device Exemption; Pediatric Patients.--Section
520(m)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360j(m)(3)) is amended--
(1) by striking ``(3) No person'' and inserting ``(3)(A)
Except as provided in subparagraph (B), no person''; and
(2) by adding at the end the following:
``(B)(i) Subparagraph (A) does not apply with respect to any device
intended for the treatment or diagnosis of a pediatric condition.
``(ii) For purposes of this subsection:
``(I) The term `pediatric condition' means a disease,
disorder, or other condition unique to, more serious, or more
prevalent in pediatric patients.
``(II) The term `pediatric patient' means a patient who is
under 15 years of age at the time of diagnosis or treatment.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Mr. Greenwood moved to suspend the rules and pass the bill.
Considered under suspension of the rules. (consideration: CR H109-112)
DEBATE - The House proceeded with forty minutes of debate on H.R. 3493.
At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.
Considered as unfinished business. (consideration: CR H113)
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 333 - 0 (Roll no. 7).(CR H109-110)
Roll Call #7 (House)On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 333 - 0 (Roll no. 7). (CR H109-110)
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Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.