H. R. 5651—26
Such report also shall include the Secretary’s specific recommenda-
tion on whether responsibility for regulating such devices should
be reassigned to those persons within the Food and Drug Adminis-
tration 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.
SEC. 206. ELECTRONIC LABELING.
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.’’.
SEC. 207. ELECTRONIC REGISTRATION.
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 sub-
mitted 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.’’.
SEC. 208. INTENDED USE.
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).
SEC. 209. MODULAR REVIEW.
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 com-
plete, ready, and appropriate for review, except that such require-
ment 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 require-
ments 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.’’.
H. R. 5651—27
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 at the end the following:
‘‘Where appropriate, the Secretary shall ensure that such panel
includes, or consults with, one or more pediatric experts.’’.
SEC. 211. INTERNET LIST OF CLASS II DEVICES EXEMPTED FROM
REQUIREMENT 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.’’.
SEC. 212. STUDY BY INSTITUTE OF MEDICINE OF POSTMARKET
SURVEILLANCE 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 pedi-
atric populations.
(b) CERTAIN MATTERS.—The Secretary shall ensure that deter-
minations made in the study under subsection (a) include deter-
minations 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 popu-
lations 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.
SEC. 213. GUIDANCE REGARDING PEDIATRIC DEVICES.
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:
H. R. 5651—28
(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 investiga-
tions of the safety or effectiveness of such devices.
SEC. 214. BREAST IMPLANTS; STUDY BY COMPTROLLER GENERAL.
(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 effective-
ness 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 expla-
nations 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 Con-
gress 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.
SEC. 
215. 
BREAST 
IMPLANTS; 
RESEARCH 
THROUGH 
NATIONAL
INSTITUTES OF 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
H. R. 5651—29
breast implants, both gel and saline filled. Such research studies
may include the following:
‘‘(1) Developing and examining techniques to measure con-
centrations 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.’’.
TITLE III—ADDITIONAL AMENDMENTS
SEC. 301. IDENTIFICATION OF MANUFACTURER OF MEDICAL DEVICES.
(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 manu-
facturer, 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 introduc-
tion into interstate commerce after such effective date.
SEC. 302. SINGLE-USE MEDICAL DEVICES.
(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 ll.’ 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