SEC. 2. IDENTIFICATION AND TRACKING OF BIOLOGICAL 
IMPLANTS USED IN DEPARTMENT OF VET-
ERANS AFFAIRS MEDICAL FACILITIES. 
(a) IN GENERAL.—Subchapter II of chapter 73 of 
title 38, United States Code, is amended by adding at the 
end the following new section: 
‘‘§ 7330B. Identification and tracking of biological im-
plants 
‘‘(a) STANDARD IDENTIFICATION SYSTEM FOR BIO-
LOGICAL
IMPLANTS.—The Secretary shall adopt the 
unique device identification system developed for medical 
devices by the Food and Drug Administration pursuant 
to section 519(f) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360i(f)), or implement a comparable 
standard identification system, for use in identifying bio-
logical implants intended for use in medical procedures 
conducted in medical facilities of the Department. 
‘‘(b) BIOLOGICAL IMPLANT TRACKING SYSTEM.—(1) 
The Secretary shall implement a system for tracking the 
biological implants referred to in subsection (a) from 
donor to implantation. Such system shall be compatible 
with the identification system adopted or implemented 
under subsection (a). 
‘‘(2) The Secretary shall implement inventory con-
trols compatible with the tracking system implemented 
under paragraph (1) so that all patients who have re-
VerDate Mar 15 2010 
19:03 Apr 04, 2014
Jkt 039200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H4374.IH
H4374
emcdonald on DSK67QTVN1PROD with BILLS
ceived, in a medical facility of the Department, a biological 
implant subject to a recall by the Food and Drug Adminis-
tration can be notified of the recall, if based on the evalua-
tion of appropriate medical personnel of the Department 
of the risks and benefits, the Secretary determines such 
notification is appropriate. 
‘‘(c) CONSISTENCY WITH FOOD AND DRUG ADMINIS-
TRATION REGULATIONS.—To the extent that a conflict 
arises between this section and a provision of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) 
or sections 351 or 361 of the Public Health Service Act 
(42 U.S.C. 262) (including any regulations issued under 
such Acts), the provision the Federal Food, Drug, and 
Cosmetic Act or Public Health Service Act (including any 
regulations issued under such Acts) shall apply. 
‘‘(d) DEFINITION OF BIOLOGICAL IMPLANT.—In this 
section, the term ‘biological implant’ means any human 
cell, tissue, or cellular or tissue-based product— 
‘‘(1) under the meaning given the term ‘human 
cells’ in section 1271.3 of title 21, Code of Federal 
Regulations, or any successor regulation; or 
‘‘(2) that is regulated as a device under subpart 
A of part 801 of title 21, Code of Federal Regula-
tions, or any successor regulation.’’. 
VerDate Mar 15 2010 
19:03 Apr 04, 2014
Jkt 039200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H4374.IH
H4374
emcdonald on DSK67QTVN1PROD with BILLS
(b) CLERICAL AMENDMENT.—The table of sections 
at the beginning of such chapter is amended by adding 
at the end of the items relating to such subchapter the 
following new item: 
‘‘7330B. Identification and tracking of biological implants.’’. 
(c) IMPLEMENTATION DEADLINES.— 
(1) STANDARD IDENTIFICATION SYSTEM.— 
(A) IN GENERAL.—With respect to biologi-
cal implants described in paragraph (1) of sub-
section (d) of section 7330B of title 38, United 
States Code, as added by subsection (a), the 
Secretary of Veterans Affairs shall adopt or im-
plement a standard identification system for bi-
ological implants, as required by subsection (a) 
of such section, by not later than the date that 
is 180 days after the date of the enactment of 
this Act. 
(B) IMPLANTS REGULATED AS DEVICES.— 
With respect to biological implants described in 
paragraph (2) of subsection (d) of such section, 
the Secretary of Veterans Affairs shall adopt or 
implement such standard identification system 
in compliance with the compliance dates estab-
lished by the Food and Drug Administration 
pursuant to section 519(f) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360i(f)). 
VerDate Mar 15 2010 
19:03 Apr 04, 2014
Jkt 039200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H4374.IH
H4374
emcdonald on DSK67QTVN1PROD with BILLS
(2) TRACKING SYSTEM.—The Secretary of Vet-
erans Affairs shall implement the biological implant 
tracking system required by subsection (b) of section 
7330B, as added by subsection (a), by not later than 
the date that is 180 days after the date of the enact-
ment of this Act. 
(d) REPORTING REQUIREMENT.—If the biological 
implant tracking system required by subsection (b) of such 
section is not operational by the date that is 180 days 
after the date of the enactment of this Act, the Secretary 
of Veterans Affairs shall provide to the Committees on 
Veterans’ Affairs of the Senate and House of Representa-
tives a written explanation for each month until such time 
as the system is operational. Each such explanation shall 
describe each impediment to the implementation of the 
system, steps being taken to remediate each such impedi-
ment, and target dates for a solution to each such impedi-
ment. 
SEC. 3. PROCUREMENT OF BIOLOGICAL IMPLANTS USED IN 
DEPARTMENT OF VETERANS AFFAIRS MED-
ICAL FACILITIES. 
(a) PROCUREMENT.— 
(1) IN GENERAL.—Subchapter II of chapter 81 
of such title is amended by adding at the end the 
following new section: 
VerDate Mar 15 2010 
19:03 Apr 04, 2014
Jkt 039200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H4374.IH
H4374
emcdonald on DSK67QTVN1PROD with BILLS
‘‘§ 8129. Procurement of biological implants 
‘‘(a) IN GENERAL.—(1) The Secretary may procure 
biological implants only from vendors that meet the fol-
lowing conditions: 
‘‘(A) The vendor uses the standard identifica-
tion system adopted or implemented by the Sec-
retary under section 7330B(a) of this title and has 
safeguards to ensure that a production identifier has 
been in place at each step of distribution of each bio-
logical implant from its donor. 
‘‘(B) The vendor is registered with the Food 
and Drug Administration under subpart B of part 
1271 of title 21, Code of Federal Regulations, or 
any successor regulation, and in the case of a vendor 
that uses tissue distribution intermediaries, the ven-
dor uses only tissue distribution intermediaries that 
are appropriately registered with the Food and Drug 
Administration. 
‘‘(C) The vendor ensures that donor eligibility 
determinations and such other records as the Sec-
retary may require accompany each biological im-
plant at all times, regardless of the country of origin 
of the donor of the biological material. 
‘‘(D) The vendor consents to periodic inspec-
tions and audits by the Department of Veterans Af-
VerDate Mar 15 2010 
19:03 Apr 04, 2014
Jkt 039200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H4374.IH
H4374
emcdonald on DSK67QTVN1PROD with BILLS
fairs regarding the accuracy of records and the han-
dling of products. 
‘‘(E) The vendor agrees to cooperate with all bi-
ological implant recalls conducted on the vendor’s 
own initiative, by the request of the Food and Drug 
Administration, or by a statutory order of the Food 
and Drug Administration. 
‘‘(F) The vendor agrees to provide to the Sec-
retary any adverse event report or warning letter of 
the Food and Drug Administration issued to the 
vendor by not later than 30 days after the vendor 
receives such report or warning letter. 
‘‘(G) The vendor agrees to retain all records as-
sociated with the procurement of a biological implant 
by the Department for at least five years after the 
date of the procurement of the biological implant. 
‘‘(H) The vendor maintains active accreditation 
with the American Association of Tissue Banks or a 
similar national accreditation specific to biological 
implants. 
‘‘(2) The Secretary shall procure biological implants 
under the Federal Supply Schedules of the General Serv-
ices Administration, unless such implants are not available 
under such Schedules. For biological implants listed on 
the Federal Supply Schedules, the Secretary shall accom-
VerDate Mar 15 2010 
19:03 Apr 04, 2014
Jkt 039200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H4374.IH
H4374
emcdonald on DSK67QTVN1PROD with BILLS