an office to ensure the prompt assignment of combination 
products to agency centers, the timely and effective pre-
market review of such products, and consistent and appro-
priate 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 prod-
uct, 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 para-
graph 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 para-
graph (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 in-
volving more than one agency center. 
‘‘(ii) In order to ensure the timeliness of the pre-
market review of a combination product, the agency center 
with primary jurisdiction for the product, and the con-
sulting 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 pre-
sented to the Office for resolution, unless the dispute is 
clearly premature. 
‘‘(ii) During the review process, any dispute regard-
ing the substance of the premarket review may be pre-
sented to the Commissioner of Food and Drugs after first 
being considered by the agency center with primary juris-
diction of the premarket review, under the scientific dis-
pute resolution procedures for such center. The Commis-
sioner 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 Sec-
retary 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 re-
view, the Secretary shall consult with stakeholders and the 
directors of the agency centers. After such consultation, 
the Secretary shall determine whether to continue in ef-
fect, modify, revise, or eliminate such agreement, guid-
ance, 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 para-
graph shall be construed as preventing the Secretary from 
following each agreement, guidance, or practice until con-
tinued, 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 com-
bination products under review and the timeliness in 
days of such assignments, reviews, and dispute reso-
lutions; 
‘‘(ii) identifying the number of premarket re-
views of such products that involved a consulting 
agency center; and 
‘‘(iii) describing improvements in the consist-
ency of postmarket regulation of combination prod-
ucts. 
‘‘(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 para-
graph (2) of this section)—
(A) by redesignating subparagraphs (A) 
and (B) as subparagraphs (B) and (C), respec-
tively; 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.’’. 
SEC. 205. REPORT ON CERTAIN DEVICES. 
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 re-
views 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 submis-
sions and supplements, times required to review manufac-
turers’ replies to submissions, and times to approve or 
clear such devices. Such report shall contain the Sec-
retary’s recommendations on any measures needed to im-
prove performance including, but not limited to, the alloca-
tion of additional resources. Such report also shall include 
the Secretary’s specific recommendation on whether re-
sponsibility for regulating such devices should be reas-
signed to those persons within the Food and Drug Admin-
istration 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 Cos-
metic Act (21 U.S.C. 352(f)) is amended by adding at the 
end the following: ‘‘Required labeling for prescription de-
vices intended for use in health care facilities may be made 
available solely by electronic means provided that the la-
beling 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 facil-
ity 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 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 request-
ing 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 Cos-
metic 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 re-
view 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 por-
tion of a submission under subparagraph (A) is unaccept-
able, the Secretary shall, in writing, provide to the appli-
cant 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.’’. 
SEC. 210. PEDIATRIC EXPERTISE REGARDING CLASSIFICA-
TION-PANEL REVIEW OF PREMARKET APPLI-
CATIONS. 
Section 515(c) of the Federal Food, Drug, and Cos-
metic 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 NOTI-
FICATION. 
Section 510(m)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(m)(1)) is amended by add-
ing at the end the following: ‘‘The Secretary shall publish 
such list on the Internet site of the Food and Drug Ad-
ministration. 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 ‘‘Sec-
retary’’) 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 dura-
tion to evaluate the impact of growth and develop-
ment for the number of years that the child will 
have the implant, and whether the studies are ade-
quate 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 commit-
ments made at the time of approval of medical de-
vices, such as phase IV trials, and the Secretary’s 
monitoring and use of adverse reaction reports, reg-
istries, and other postmarket surveillance activities. 
(c) REPORT TO CONGRESS.—The Secretary shall en-
sure 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 Con-
gress. 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 enact-
ment of this Act, the Secretary of Health and Human 
Services shall issue guidance on the following: 
(1) The type of information necessary to pro-
vide reasonable assurance of the safety and effective-
ness 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. 
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 fol-
lowing with respect to breast implants: 
(1) The content of information typically pro-
vided 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 pro-
vided. 
(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 up-
dated. 
(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 pro-
vided information regarding the provision of in-
formed 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.
SEC. 215. BREAST IMPLANTS; RESEARCH THROUGH NA-
TIONAL 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 In-
stitutes. 
(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 con-
duct or support research to examine the long-term health 
implications of silicone breast implants, both gel and sa-
line filled. Such research studies may include the fol-
lowing:
‘‘(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.’’. 
TITLE III—ADDITIONAL 
AMENDMENTS 
SEC. 301. IDENTIFICATION OF MANUFACTURER OF MED-
ICAL 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 ab-
breviation of such name, or a unique and generally recog-
nized symbol identifying such manufacturer, except that 
the Secretary may waive any requirement under this para-
graph for the device if the Secretary determines that com-
pliance with the requirement is not feasible for the device 
or would compromise the provision of reasonable assur-
ance 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 in-
troduced or delivered for introduction into interstate com-
merce 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 sec-
tion 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. Re-
processed 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 sub-
section 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 steriliza-
tion, and functional performance demonstrating that 
the single-use device will remain substantially equiv-
alent to its predicate device after the maximum 
number of times the device is reprocessed as in-
tended by the person submitting the premarket noti-
fication. Within six months after enactment of this 
subsection, the Secretary shall publish in the Fed-
eral 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 sub-
section (k) that was submitted to the Secretary be-
fore the publication of the initial list under subpara-
graph (A), or any revision thereof, and was for a de-
vice or type of device included on such list, the per-
son who submitted the report under subsection (k) 
shall submit validation data as described in subpara-
graph (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 sub-
mission of the validation data to the Secretary, the 
Secretary may not determine that the device is mis-
branded under section 502(o), adulterated under 
section 501(f)(1)(B), or take action against the de-
vice under section 301(p) for failure to provide any 
information required by subsection (k) until (i) the 
review is terminated by withdrawal of the submis-
sion of the report under subsection (k); (ii) the Sec-
retary finds the data to be acceptable and issues a 
letter; or (iii) the Secretary determines that the de-
vice is not substantially equivalent to a predicate de-
vice. Upon a determination that a device is not sub-
stantially 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, re-
quire 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 reproc-
essed 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 as-
surance of the safety and effectiveness of the de-
vices. 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 termi-
nates 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), adulter-
ated 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 ini-
tial 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 pub-
lished 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 re-
quired 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 Fed-
eral 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 ap-
proval’’; 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 re-
port seeking premarket approval for a class III device re-
ferred 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 reproc-
essing and packing of the device. 
‘‘(viii) Such samples of the device that the Sec-
retary 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, in-
cluding information of the type required in para-
graph (1) for an application under such paragraph, 
that the Secretary determines is necessary to deter-
mine 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 sub-
mitting 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 ap-
plies 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 con-
sidered to be a reference to a report under subpara-
graph (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, sus-
pended, 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 sub-
paragraph (A) has been approved, or has been de-
nied, 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 sin-
gle-use device, means an original device that has pre-
viously 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 in-
tended 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 in-
tended to contact intact mucous membranes and not pene-
trate normally sterile areas of the body.’’.
SEC. 303. MEDWATCH. 
Not later than 6 months after the date of the enact-
ment of this Act, the Secretary of Health and Human 
Services shall modify the MedWatch mandatory and vol-
untary forms to facilitate the reporting of information by 
user facilities or distributors as appropriate relating to re-
processed single-use devices, including the name of the re-
processor and whether the device has been reused.
Æ