[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5651 Enrolled Bill (ENR)]
H.R.5651
One Hundred Seventh Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Wednesday,
the twenty-third day of January, two thousand and two
An Act
To amend the Federal Food, Drug, and Cosmetic Act to make improvements
in the regulation of medical devices, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,

d1243e630c7db342e22de502272ff856ed7de2d00fdb4d3be7d32403ec8c05bb

(a) Short Title.--This Act may be cited as the ``Medical Device
User Fee and Modernization Act of 2002''.
(b) Table of Contents.--The table of contents for this Act is as
follows:

013885a0b5e6526c3e9dd540512fdf4ac293332ba343ad99a24e9609cbb2214b

8eae297d410d0c3161849d2484df6cf51a6dd7c4f3f933e9e8d2e6af220b89e7

TITLE II

-AMENDMENTS REGARDING REGULATION OF MEDICAL DEVICES

8a174f7af9ac8c7d980f8ac11815a468b0ff0b09abcb0856c59186ddc73abaa0

432119aaa9d656fa8aabb1dd59d5361265e4fa52029e798fd851ccc9d934bff9

9fa9f14bb78dd3b02d649d80584c81d7e570ee80bfef3e7d0052f5c749088518

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 making additional funds
available for the purpose of augmenting the resources of the Food
and Drug Administration that are devoted to the process for the
review of devices and the assurance of device safety and
effectiveness so that statutorily mandated deadlines may be met;
and
(3) the fees authorized by this title will be dedicated to
meeting the goals identified in the letters from the Secretary of
Health and Human Services to the Committee on Energy and Commerce
of the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate, as set forth in the
Congressional Record.

0c12cdc44292325cc1629c0d07d09701b141de9b622b0ee1474c5bb613eb292c

TITLE I

-FEES RELATED TO MEDICAL DEVICES

9e8df9569d6676dc59ce533e179573a90742ce652610dd36d504bb0cf677b2c3

Beginning with fiscal year 2003, the Secretary shall prepare and
submit 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 report concerning--
(1) the progress of the Food and Drug Administration in
achieving the goals identified in the letters described in section
101(3) during such fiscal year and the future plans of the Food and
Drug Administration for meeting the goals, not later than 60 days
after the end of each fiscal year during which fees are collected
under this part; and
(2) the implementation of the authority for such fees during
such fiscal year, and the use, by the Food and Drug Administration,
of the fees collected during such fiscal year, not later than 120
days after the end of each fiscal year during which fees are
collected under the medical device user-fee program established
under the amendment made by section 102.

6e19ad1ebab58205ed95dd4ff5d3f5f73de28db55867ed32f9071b80a27f74e4

(a) Additional Authorization of Appropriations.--For the purpose of
carrying out postmarket surveillance of medical devices, there are
authorized to be appropriated to the Food and Drug Administration the
following amounts, stated as increases above the amount obligated for
such purpose by such Administration for fiscal year 2002:
(1) For fiscal year 2003, an increase of $3,000,000.
(2) For fiscal year 2004, an increase of $6,000,000.
(3) For fiscal year 2005 and each subsequent fiscal year, an
increase of such sums as may be necessary.
(b) Study.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall conduct a
study for the purpose of determining the following with respect to
the medical device user-fee program established under the amendment
made by section 102:
(A) The impact of such program on the ability of the Food
and Drug Administration to conduct postmarket surveillance on
medical devices.
(B) The programmatic improvements, if any, needed for
adequate postmarket surveillance of medical devices.
(C) The amount of funds needed to conduct adequate
postmarket surveillance of medical devices.
(D) The extent to which device companies comply with the
postmarket surveillance requirements, including postmarket
study commitments.
(E) The recommendations of the Secretary as to whether, and
in what amounts, user fees collected under such user-fee
program should be dedicated to postmarket surveillance if the
program is extended beyond fiscal year 2007.
(2) Report.--Not later than January 10, 2007, the Secretary
shall submit 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 report that describes the findings of
the study under paragraph (1).

8c0e675a8ab5c0a6bf2249ef2f907f0f2b80f9d2c0b0a6970e67c015bd33740b

(a) In General.--In developing recommendations to the Congress for
the goals and plans for meeting the goals for the process for the
review of medical device applications for fiscal years after fiscal
year 2007, and for the reauthorization of sections 737 and 738 of the
Federal Food, Drug, and Cosmetic Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'') shall
consult with the Committee on Energy and Commerce of the House of
Representatives, the Committee on Health, Education, Labor, and
Pensions of the Senate, appropriate scientific and academic experts,
health care professionals, representatives of patient and consumer
advocacy groups, and the regulated industry.
(b) Recommendations.--The Secretary shall publish in the Federal
Register recommendations under subsection (a), after negotiations with
the regulated industry; shall present such recommendations to the
congressional committees specified in such paragraph; shall hold a
meeting at which the public may present its views on such
recommendations; and shall provide for a period of 30 days for the
public to provide written comments on such recommendations.

3773522fee59b3cedf3ac586f4f17956e6207deb7a3cd8bcda9c83c3840898d7

The amendments made by this title shall take effect on the date of
the enactment of this Act, except that fees shall be assessed for all
premarket applications, premarket reports, supplements, and premarket
notification submissions received on or after October 1, 2002,
regardless of the date of enactment.

db396d82f832b42532b280c91509d2ac9c82426c479e4cfd4a444d88126f72ea

The amendments made by this title cease to be effective October 1,
2007, except that section 103 with respect to annual reports ceases to
be effective January 31, 2008.

cc05b33cd09258f8db69adb801633d24414b138a17c54c9d88813f2dcc2ec0af

6e890410b7a7452b9e47f2e121ca0b53d818ae109c092c74be761882c0795638

Section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360m) is amended--
(1) in subsection (c), by striking ``The authority'' and all
that follows and inserting the following: ``The authority provided
by this section terminates October 1, 2007.''; and
(2) by adding at the end the following subsection:
``(d) Report.--Not later than January 10, 2007, the Secretary shall
conduct a study based on the experience under the program under this
section and submit 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 report describing the findings of the study.
The objectives of the study shall include determining--
``(1) the number of devices reviewed under this section;
``(2) the number of devices reviewed under this section that
were ultimately cleared by the Secretary;
``(3) the number of devices reviewed under this section that
were ultimately not cleared by the Secretary;
``(4) the average time period for a review under this section
(including the time it takes for the Secretary to review a
recommendation of an accredited person under subsection (a) and
determine the initial device classification);
``(5) the average time period identified in paragraph (4)
compared to the average time period for review of devices solely by
the Secretary pursuant to section 510(k);
``(6) if there is a difference in the average time period under
paragraph (4) and the average time period under paragraph (5), the
reasons for such difference;
``(7) whether the quality of reviews under this section for
devices for which no guidance has been issued is qualitatively
inferior to reviews by the Secretary for devices for which no
guidance has been issued;
``(8) whether the quality of reviews under this section of
devices for which no guidance has been issued is qualitatively
inferior to reviews under this section of devices for which
guidance has been issued;
``(9) whether this section has in any way jeopardized or
improved the public health;
``(10) any impact of this section on resources available to the
Secretary to review reports under section 510(k); and
``(11) any suggestions for continuation, modification
(including contraction or expansion of device eligibility), or
termination of this section that the Secretary determines to be
appropriate.''.

be86033697da19d2200e605034de0114f5ac3d6729a83c72e1cb2aa0d5d13c4d

Section 306 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
335a) is amended by adding at the end the following subsection:
``(m) Devices; Mandatory Debarment Regarding Third-Party
Inspections and Reviews.--
``(1) In general.--If the Secretary finds that a person has
been convicted of a felony under section 301(gg), the Secretary
shall debar such person from being accredited under section 523(b)
or 704(g)(2) and from carrying out activities under an agreement
described in section 803(b).
``(2) Debarment period.--The Secretary shall debar a person
under paragraph (1) for the following periods:
``(A) The period of debarment of a person (other than an
individual) shall not be less than 1 year or more than 10
years, but if an act leading to a subsequent debarment under
such paragraph occurs within 10 years after such person has
been debarred under such paragraph, the period of debarment
shall be permanent.
``(B) The debarment of an individual shall be permanent.
``(3) Termination of debarment; judicial review; other
matters.--Subsections (c)(3), (d), (e), (i), (j), and (l)(1) apply
with respect to a person (other than an individual) or an
individual who is debarred under paragraph (1) to the same extent
and in the same manner as such subsections apply with respect to a
person who is debarred under subsection (a)(1), or an individual
who is debarred under subsection (a)(2), respectively.''.

2151c60a2d8ecbc0868dc7f16c6a92368ed6a0bcb549b83b149ccb83feaf03fd

Section 503(g) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 353(g)) is amended--
(1) in paragraph (1)--
(A) in the first sentence, by striking ``shall designate a
component of the Food and Drug Administration'' and inserting
``shall in accordance with this subsection assign an agency
center''; and
(B) in each of subparagraphs (A) through (C), by striking
``the persons charged'' and inserting ``the agency center
charged'';
(2) by redesignating paragraph (4) as paragraph (5);
(3) by inserting after paragraph (3) the following paragraph:
``(4)(A) Not later than 60 days after the date of the enactment of
this paragraph, the Secretary shall establish within the Office of the
Commissioner of Food and Drugs an office to ensure the prompt
assignment of combination products to agency centers, the timely and
effective premarket review of such products, and consistent and
appropriate postmarket regulation of like products subject to the same
statutory requirements to the extent permitted by law. Additionally,
the office shall, in determining whether a product is to be designated
a combination product, consult with the component within the Office of
the Commissioner of Food and Drugs that is responsible for such
determinations. Such office (referred to in this paragraph as the
`Office') shall have appropriate scientific and medical expertise, and
shall be headed by a director.
``(B) In carrying out this subsection, the Office shall, for each
combination product, promptly assign an agency center with primary
jurisdiction in accordance with paragraph (1) for the premarket review
of such product.
``(C)(i) In carrying out this subsection, the Office shall ensure
timely and effective premarket reviews by overseeing the timeliness of
and coordinating reviews involving more than one agency center.
``(ii) In order to ensure the timeliness of the premarket review of
a combination product, the agency center with primary jurisdiction for
the product, and the consulting agency center, shall be responsible to
the Office with respect to the timeliness of the premarket review.
``(D) In carrying out this subsection, the Office shall ensure the
consistency and appropriateness of postmarket regulation of like
products subject to the same statutory requirements to the extent
permitted by law.
``(E)(i) Any dispute regarding the timeliness of the premarket
review of a combination product may be presented to the Office for
resolution, unless the dispute is clearly premature.
``(ii) During the review process, any dispute regarding the
substance of the premarket review may be presented to the Commissioner
of Food and Drugs after first being considered by the agency center
with primary jurisdiction of the premarket review, under the scientific
dispute resolution procedures for such center. The Commissioner of Food
and Drugs shall consult with the Director of the Office in resolving
the substantive dispute.
``(F) The Secretary, acting through the Office, shall review each
agreement, guidance, or practice of the Secretary that is specific to
the assignment of combination products to agency centers and shall
determine whether the agreement, guidance, or practice is consistent
with the requirements of this subsection. In carrying out such review,
the Secretary shall consult with stakeholders and the directors of the
agency centers. After such consultation, the Secretary shall determine
whether to continue in effect, modify, revise, or eliminate such
agreement, guidance, or practice, and shall publish in the Federal
Register a notice of the availability of such modified or revised
agreement, guidance or practice. Nothing in this paragraph shall be
construed as preventing the Secretary from following each agreement,
guidance, or practice until continued, modified, revised, or
eliminated.
``(G) Not later than one year after the date of the enactment of
this paragraph and annually thereafter, the Secretary shall report to
the appropriate committees of Congress on the activities and impact of
the Office. The report shall include provisions--
``(i) describing the numbers and types of combination products
under review and the timeliness in days of such assignments,
reviews, and dispute resolutions;
``(ii) identifying the number of premarket reviews of such
products that involved a consulting agency center; and
``(iii) describing improvements in the consistency of
postmarket regulation of combination products.
``(H) Nothing in this paragraph shall be construed to limit the
regulatory authority of any agency center.''; and
(4) in paragraph (5) (as redesignated by paragraph (2) of this
section)--
(A) by redesignating subparagraphs (A) and (B) as
subparagraphs (B) and (C), respectively; and
(B) by inserting before subparagraph (B) the following
subparagraph:
``(A) The term `agency center' means a center or alternative
organizational component of the Food and Drug Administration.''.

342c00f865ac628eae77936b2ab0b018bbcfaba996aec0440401f723bbe59346

Not later than one year after the date of enactment of this Act,
the Secretary of Health and Human Services shall report to the
appropriate committees of Congress on the timeliness and effectiveness
of device premarket reviews by centers other than the Center for
Devices and Radiological Health. Such report shall include information
on the times required to log in and review original submissions and
supplements, times required to review manufacturers' replies to
submissions, and times to approve or clear such devices. Such report
shall contain the Secretary's recommendations on any measures needed to
improve performance including, but not limited to, the allocation of
additional resources. Such report also shall include the Secretary's
specific recommendation on whether responsibility for regulating such
devices should be reassigned to those persons within the Food and Drug
Administration who are primarily charged with regulating other types of
devices, and whether such a transfer could have a deleterious impact on
the public health and on the safety of such devices.

69e878abc7e19b0d053f38cdb5a7a78ad99eb17d869d10d68689e01007527c30

Section 502(f) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 352(f)) is amended by adding at the end the following:
``Required labeling for prescription devices intended for use in health
care facilities may be made available solely by electronic means
provided that the labeling complies with all applicable requirements of
law and, that the manufacturer affords health care facilities 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.''.

67dbb6958c1df711db94373184d111289ee9013cc30392ce4e93a73d57e83c4d

Section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360) is amended by adding at the end the following:
``(p) Registrations under subsections (b), (c), (d), and (i)
(including the submission of updated information) shall be submitted to
the Secretary by electronic means, upon a finding by the Secretary that
the electronic receipt of such registrations is feasible, unless the
Secretary grants a request for waiver of such requirement because use
of electronic means is not reasonable for the person requesting such
waiver.''.

41026715783594840cbd48d1738a4b63b187e458d51ce4c30d9459e33fad53b4

Section 513(i)(1)(E) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360c(i)(1)(E)) is amended by striking clause (iv).

24859ecb36aa50c1685b79582319fd14b4c39b4e91dd7998e6dd695a65a8eaf3

Section 515(c) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360e(c)) is amended by adding at the end the following:
``(3)(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 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.''.

0c756be3c647ca078b94539558d822fa98737900846c84e3a9b3709029e6bcf4

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 at the end the following: ``Where
appropriate, the Secretary shall ensure that such panel includes, or
consults with, one or more pediatric experts.''.

b46bb9a389905eb9af4831a639d05ff605377615d68a1dbfe1d0db3e8bbfb56a

OF PREMARKET NOTIFICATION.
Section 510(m)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360(m)(1)) is amended by adding at the end the following: ``The
Secretary shall publish such list on the Internet site of the Food and
Drug Administration. The list so published shall be updated not later
than 30 days after each revision of the list by the Secretary.''.

d7ae7d0e98d9e7256312c183b64929d5b799017345086c236ae218410eaa9329

REGARDING PEDIATRIC POPULATIONS.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall request the
Institute of Medicine to enter into an agreement with the Secretary
under which such Institute conducts a study for the purpose of
determining whether the system under the Federal Food, Drug, and
Cosmetic Act for the postmarket surveillance of medical devices
provides adequate safeguards regarding the use of devices in pediatric
populations.
(b) Certain Matters.--The Secretary shall ensure that
determinations made in the study under subsection (a) include
determinations of--
(1) whether postmarket surveillance studies of implanted
medical devices are of long enough duration to evaluate the impact
of growth and development for the number of years that the child
will have the implant, and whether the studies are adequate to
evaluate how children's active lifestyles may affect the failure
rate and longevity of the implant; and
(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.
(c) Report to Congress.--The Secretary shall ensure that, not later
than four years after the date of the enactment of this Act, a report
describing the findings of the study under subsection (a) is submitted
to the Congress. The report shall include any recommendations of the
Secretary for administrative or legislative changes to the system of
postmarket surveillance referred to in such subsection.

e32933a1b75a99c787a7b77c782786d86ffc55d3ab5d4c8c62fa61cee4c03413

Not later than 270 days after the date of the enactment of this
Act, the Secretary of Health and Human Services shall issue guidance on
the following:
(1) The type of information necessary to provide reasonable
assurance of the safety and effectiveness of medical devices
intended for use in pediatric populations.
(2) Protections for pediatric subjects in clinical
investigations of the safety or effectiveness of such devices.

51107e4788c9b66bed8d813042d4cf035fd4ed6c4b5baf7ec9af47416f6b9adc

(a) In General.--The Comptroller General of the United States shall
conduct a study to determine the following with respect to breast
implants:
(1) The content of information typically provided by health
professionals to women who consult with such professionals on the
issue of whether to undergo breast implant surgery.
(2) Whether such information is provided by physicians or other
health professionals, and whether the information is provided
verbally or in writing, and at what point in the process of
determining whether to undergo surgery is such information
provided.
(3) Whether the information presented, as a whole, provides a
complete and accurate discussion of the risks and benefits of
breast implants, and the extent to which women who receive such
information understand the risks and benefits.
(4) The number of adverse events that have been reported, and
whether such events have been adequately investigated.
(5) With respect to women who participate as subjects in
research being carried out regarding the safety and effectiveness
of breast implants:
(A) The content of information provided to the women during
the process of obtaining the informed consent of the women to
be subjects, and the extent to which such information is
updated.
(B) Whether such process provides written explanations of
the criteria for being subjects in the research.
(C) The point at which, in the planning or conduct of the
research, the women are provided information regarding the
provision of informed consent to be subjects.
(b) Report.--The Comptroller General shall submit to the Congress a
report describing the findings of the study.
(c) Definition.--For purposes of this section, the term ``breast
implant'' means a breast prosthesis that is implanted to augment or
reconstruct the female breast.

6eaea2a3b81d210be7ccf3cca10397d7250de257b166e60ed77467b6ee876f16

HEALTH.
(a) Report on Status of Current Research.--Not later than 180 days
after the date of the enactment of this Act, the Director of the
National Institutes of Health shall submit to the Congress a report
describing the status of research on breast implants (as defined in
section 213(c)) being conducted or supported by such Institutes.
(b) Research on Long-Term Implications.--Part H of title IV of the
Public Health Service Act (42 U.S.C. 289 et seq.) is amended by adding
at the end of the following section:
``SEC. 498C. BREAST IMPLANT RESEARCH.
``(a) In General.--The Director of NIH may conduct or support
research to examine the long-term health implications of silicone
breast implants, both gel and saline filled. Such research studies may
include the following:
``(1) Developing and examining techniques to measure
concentrations of silicone in body fluids and tissues.
``(2) Surveillance of recipients of silicone breast implants,
including long-term outcomes and local complications.
``(b) Definition.--For purposes of this section, the term `breast
implant' means a breast prosthesis that is implanted to augment or
reconstruct the female breast.''.

65d1ee42461449a784f45f03995b47d788e76030e2b603db84cf61897c30a1a7

(a) In General.--Section 502 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the
following:
``(u) If it is a device, unless it, or an attachment thereto,
prominently and conspicuously bears the name of the manufacturer of the
device, a generally recognized abbreviation of such name, or a unique
and generally recognized symbol identifying such manufacturer, except
that the Secretary may waive any requirement under this paragraph for
the device if the Secretary determines that compliance with the
requirement is not feasible for the device or would compromise the
provision of reasonable assurance of the safety or effectiveness of the
device.''.
(b) Effective Date.--The amendment made by subsection (a) takes
effect 18 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.

1b14281f2de1e837afe8daad0d22afbeb8b0d57f6886a83c6a35289017bede98

TITLE III

-ADDITIONAL AMENDMENTS

(a) Required Statements on Labeling.--
(1) In general.--Section 502 of the Federal Food, Drug, and
Cosmetic Act, as amended by section 301 of this Act, is amended by
adding at the end the following:
``(v) If it is a reprocessed single-use device, unless all labeling
of the device prominently and conspicuously bears the statement
`Reprocessed device for single use. Reprocessed by ____.' The name of
the manufacturer of the reprocessed device shall be placed in the space
identifying the person responsible for reprocessing.''.
(2) Effective date.--The amendment made by paragraph (1) takes
effect 15 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.
(b) Premarket Notification.--Section 510 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360) is amended by inserting after
subsection (n) the following:
``(o)(1) With respect to reprocessed single-use devices for which
reports are required under subsection (k):
``(A) The Secretary shall identify such devices or types of
devices for which reports under such subsection must, in order to
ensure that the device is substantially equivalent to a predicate
device, include validation data, the types of which shall be
specified by the Secretary, regarding cleaning and sterilization,
and functional performance demonstrating that the single-use device
will remain substantially equivalent to its predicate device after
the maximum number of times the device is reprocessed as intended
by the person submitting the premarket notification. Within six
months after enactment of this subsection, the Secretary shall
publish in the Federal Register a list of the types so identified,
and shall revise the list as appropriate. Reports under subsection
(k) for devices or types of devices within a type included on the
list are, upon publication of the list, required to include such
validation data.
``(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 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.
``(C) In the case of a report under subsection (k) for a device
identified under subparagraph (A) that is of a type for which the
Secretary has not previously received a report under such
subsection, the Secretary may, in advance of revising the list
under subparagraph (A) to include such type, require that the
report include the validation data specified in subparagraph (A).
``(D) Section 502(o) applies with respect to the failure of a
report under subsection (k) to include validation data required
under subparagraph (A).
``(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) The Secretary shall identify such devices or types of
devices for which such exemptions should be terminated in order to
provide a reasonable assurance of the safety and effectiveness of
the devices. The Secretary shall publish in the Federal Register a
list of the devices or types of devices so identified, and shall
revise the list as appropriate. The exemption for each device or
type included on the list is terminated upon the publication of the
list. For each report under subsection (k) submitted pursuant to
this subparagraph the Secretary shall require the validation data
described in paragraph (1)(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 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.
``(C) In the case of semi-critical devices, the initial list
under subparagraph (A) shall be published not later than 18 months
after the effective date of this subsection. In the case of
critical devices, the initial list under such subparagraph shall be
published not later than six months after such effective date.
``(D) Section 502(o) applies with respect to the failure to
submit a report under subsection (k) that is required pursuant to
subparagraph (A), including a failure of the report to include
validation data required in such subparagraph.
``(E) The termination under subparagraph (A) of an exemption
under subsection (l) or (m) for a critical or semicritical
reprocessed single-use device does not terminate the exemption
under subsection (l) or (m) for the original device.''.
(c) Premarket Report.--Section 515 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360e) is amended--
(1) in subsection (a), in the matter after and below paragraph
(2), by inserting before the period the following: ``or, as
applicable, an approval under subsection (c)(2) of a report seeking
premarket approval''; and
(2) in subsection (c)--
(A) by redesignating paragraph (2) as paragraph (3); and
(B) by inserting after paragraph (1) the following
paragraph:
``(2)(A) Any person may file with the Secretary a report seeking
premarket approval for a class III device referred to in subsection (a)
that is a reprocessed single-use device. Such a report shall contain
the following:
``(i) The device name, including both the trade or proprietary
name and the common or usual name.
``(ii) The establishment registration number of the owner or
operator submitting the report.
``(iii) Actions taken to comply with performance standards
under section 514.
``(iv) Proposed labels, labeling, and advertising sufficient to
describe the device, its intended use, and directions for use.
``(v) Full reports of all information, published or known to or
which should be reasonably known to the applicant, concerning
investigations which have been made to show whether or not the
device is safe or effective.
``(vi) A description of the device's components, ingredients,
and properties.
``(vii) A full description of the methods used in, and the
facilities and controls used for, the reprocessing and packing of
the device.
``(viii) Such samples of the device that the Secretary may
reasonably require.
``(ix) A financial certification or disclosure statement or
both, as required by part 54 of title 21, Code of Federal
Regulations.
``(x) A statement that the applicant believes to the best of
the applicant's knowledge that all data and information submitted
to the Secretary are truthful and accurate and that no material
fact has been omitted in the report.
``(xi) Any additional data and information, including
information of the type required in paragraph (1) for an
application under such paragraph, that the Secretary determines is
necessary to determine whether there is reasonable assurance of
safety and effectiveness for the reprocessed device.
``(xii) Validation data described in section 510(o)(1)(A) that
demonstrates that the reasonable assurance of the safety or
effectiveness of the device will remain after the maximum number of
times the device is reprocessed as intended by the person
submitting such report.
``(B) In the case of a class III device referred to in subsection
(a) that is a reprocessed single-use device:
``(i) Subparagraph (A) of this paragraph applies in lieu of
paragraph (1).
``(ii) Subject to clause (i), the provisions of this section
apply to a report under subparagraph (A) to the same extent and in
the same manner as such provisions apply to an application under
paragraph (1).
``(iii) Each reference in other sections of this Act to an
application under this section, other than such a reference in
section 737 or 738, shall be considered to be a reference to a
report under subparagraph (A).
``(iv) Each reference in other sections of this Act to a device
for which an application under this section has been approved, or
has been denied, suspended, or withdrawn, other than such a
reference in section 737 or 738, shall be considered to be a
reference to a device for which a report under subparagraph (A) has
been approved, or has been denied, suspended, or withdrawn,
respectively.''.
(d) Definitions.--Section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the
following:
``(ll)(1) The term `single-use device' means a device that is
intended for one use, or on a single patient during a single procedure.
``(2)(A) The term `reprocessed', with respect to a single-use
device, means an original device that has previously been used on a
patient and has been subjected to additional processing and
manufacturing for the purpose of an additional single use on a patient.
The subsequent processing and manufacture of a reprocessed single-use
device shall result in a device that is reprocessed within the meaning
of this definition.
``(B) A single-use device that meets the definition under clause
(A) shall be considered a reprocessed device without regard to any
description of the device used by the manufacturer of the device or
other persons, including a description that uses the term `recycled'
rather than the term `reprocessed'.
``(3) The term `original device' means a new, unused single-use
device.
``(mm)(1) The term `critical reprocessed single-use device' means a
reprocessed single-use device that is intended to contact normally
sterile tissue or body spaces during use.
``(2) The term `semi-critical reprocessed single-use device' means
a reprocessed single-use device that is intended to contact intact
mucous membranes and not penetrate normally sterile areas of the
body.''.

51dc1fff48cd2c199cbe273403ad32fb2a7165ee82b2349d7ab2ecd2e9e6c85a

Not later than 6 months after the date of the enactment of this
Act, the Secretary of Health and Human Services shall modify the
MedWatch mandatory and voluntary forms to facilitate the reporting of
information by user facilities or distributors as appropriate relating
to reprocessed single-use devices, including the name of the
reprocessor and whether the device has been reused.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.

bfb81b203f421c9746e90e0f50b35f2c90998da6f0478c551e1faa9a01df665e

Medical Device User Fee and Modernization Act of 2002

Other Sections

TITLE II

TITLE I

TITLE III

Want the full experience?