I 
116TH CONGRESS 
1ST SESSION 
H. R. 547 
To amend title 38, United States Code, to direct the Secretary of Veterans 
Affairs to adopt and implement a standard identification protocol for 
use in the tracking and procurement of biological implants by the Depart-
ment of Veterans Affairs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 15, 2019 
Mr. DAVID P. ROE of Tennessee introduced the following bill; which was 
referred to the Committee on Veterans’ Affairs 
A BILL 
To amend title 38, United States Code, to direct the Sec-
retary of Veterans Affairs to adopt and implement a 
standard identification protocol for use in the tracking 
and procurement of biological implants by the Depart-
ment of Veterans Affairs, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Biological Implant 
Tracking and Veteran Safety Act of 2019’’. 
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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: 
‘‘§ 7330D. Identification and tracking of biological im-
plants 
‘‘(a) STANDARD IDENTIFICATION SYSTEM FOR BIO-
LOGICAL IMPLANTS.—(1) The Secretary shall adopt the 
unique device identification system developed for medical 
devices by the Food and Drug Administration under sec-
tion 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 biological im-
plants intended for use in medical procedures conducted 
in medical facilities of the Department. 
‘‘(2) In adopting or implementing a standard identi-
fication system for biological implants under paragraph 
(1), the Secretary shall permit a vendor to use any of the 
accredited entities identified by the Food and Drug Ad-
ministration as an issuing agency pursuant to section 
830.100 of title 21, Code of Federal Regulations, or any 
successor regulation. 
‘‘(b) BIOLOGICAL IMPLANT TRACKING SYSTEM.—(1) 
The Secretary shall implement a system for tracking the 
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biological implants described in subsection (a) from 
human donor or animal source to implantation. 
‘‘(2) The tracking system implemented under para-
graph (1) shall be compatible with the identification sys-
tem adopted or implemented under subsection (a). 
‘‘(3) The Secretary shall implement inventory con-
trols compatible with the tracking system implemented 
under paragraph (1) so that all patients who have re-
ceived, in a medical facility of the Department, a biological 
implant subject to a recall can be notified of the recall 
if, based on the evaluation by appropriate medical per-
sonnel 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 section 351 or 361 of the Public Health Service Act 
(42 U.S.C. 262 and 264) (including any regulations issued 
under such provisions), the provision of the Federal Food, 
Drug, and Cosmetic Act or Public Health Service Act (in-
cluding any regulations issued under such provisions) shall 
apply. 
‘‘(d) BIOLOGICAL IMPLANT DEFINED.—In this sec-
tion, the term ‘biological implant’ means any human cell, 
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tissue, or cellular or tissue-based product or animal prod-
uct— 
‘‘(1) under the meaning given the term ‘human 
cells, tissues, or cellular or tissue-based products’ in 
section 1271.3 of title 21, Code of Federal Regula-
tions, or any successor regulation; or 
‘‘(2) that is regulated as a device under section 
201(h) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321(h)).’’. 
(b) CLERICAL AMENDMENT.—The table of sections 
at the beginning of such chapter is amended by inserting 
after the item relating to section 7330C the following new 
item: 
‘‘7330D. Identification and tracking of biological implants.’’. 
(c) IMPLEMENTATION DEADLINES.— 
(1) STANDARD IDENTIFICATION SYSTEM.—The 
Secretary of Veterans Affairs shall adopt or imple-
ment the standard identification system for biologi-
cal implants required by subsection (a) of section 
7330C of title 38, United States Code, as added by 
subsection (a), with respect to biological implants 
described in— 
(A) subsection (d)(1) of such section, by 
not later than the date that is 180 days after 
the date of the enactment of this Act; and 
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(B) subsection (d)(2) of such section, in 
compliance with the compliance dates estab-
lished by the Food and Drug Administration 
under section 519(f) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360i(f)). 
(2) TRACKING SYSTEM.—The Secretary of Vet-
erans Affairs shall implement the biological implant 
tracking system required by section 7330C(b) of title 
38, United States Code, as added by subsection (a), 
by not later than the date that is 180 days after the 
date of the enactment of this Act. 
(d) REPORTING REQUIREMENT.— 
(1) IN
GENERAL.—If the biological implant 
tracking system required by section 7330C(b) of title 
38, United States Code, as added by subsection (a), 
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 submit to the Committee 
on Veterans’ Affairs of the Senate and the Com-
mittee on Veterans’ Affairs of the House of Rep-
resentatives a report explaining why the system is 
not operational for each month until such time as 
the system is operational. 
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(2) ELEMENTS.—Each report submitted under 
paragraph (1) shall include a description of the fol-
lowing: 
(A) Each impediment to the implementa-
tion of the system described in such paragraph. 
(B) Steps being taken to remediate each 
such impediment. 
(C) Target dates for a solution to each 
such impediment. 
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 title 38, United States Code, is amended by add-
ing at the end the following new section: 
‘‘§ 8129. Procurement of biological implants 
‘‘(a) IN GENERAL.—(1) The Secretary may procure 
biological implants of human origin only from vendors that 
meet the following conditions: 
‘‘(A) The vendor uses the standard identifica-
tion system adopted or implemented by the Sec-
retary under section 7330C(a) of this title and has 
safeguards to ensure that a distinct identifier has 
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been in place at each step of distribution of each bio-
logical implant from its donor. 
‘‘(B) The vendor is registered as required by 
the Food and Drug Administration under subpart B 
of part 1271 of title 21, Code of Federal Regula-
tions, or any successor regulation, and in the case of 
a vendor that uses a tissue distribution intermediary 
or a tissue processor, the vendor provides assurances 
that the tissue distribution intermediary or tissue 
processor is registered as required by 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 agrees to cooperate with all 
biological implant recalls conducted on the initiative 
of the vendor, on the initiative of the original prod-
uct manufacturer used by the vendor, by the request 
of the Food and Drug Administration, or by a statu-
tory order of the Food and Drug Administration. 
‘‘(E) The vendor agrees to notify the Secretary 
of any adverse event or reaction report it provides 
to the Food and Drug Administration, as required 
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by sections 1271.3 and 1271.350 of title 21, Code 
of Federal Regulations, or any successor regulation, 
or any warning letter from the Food and Drug Ad-
ministration issued to the vendor or a tissue proc-
essor or tissue distribution intermediary used by the 
vendor by not later than 60 days after the vendor 
receives such report or warning letter. 
‘‘(F) The vendor agrees to retain all records as-
sociated with the procurement of a biological implant 
by the Department for at least 10 years after the 
date of the procurement of the biological implant. 
‘‘(G) The vendor provides assurances that the 
biological implants provided by the vendor are ac-
quired only from tissue processors that maintain ac-
tive accreditation with the American Association of 
Tissue Banks or a similar national accreditation spe-
cific to biological implants. 
‘‘(2) The Secretary may procure biological implants 
of nonhuman origin 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 7330C(a) of this title. 
‘‘(B) The vendor is registered as an establish-
ment as required by the Food and Drug Administra-
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tion under sections 807.20 and 807.40 of title 21, 
Code of Federal Regulations, or any successor regu-
lation (or is not required to register pursuant to sec-
tion 807.65(a) of such title, or any successor regula-
tion), and in the case of a vendor that is not the 
original product manufacturer of such implants, the 
vendor provides assurances that the original product 
manufacturer is registered as required by the Food 
and Drug Administration (or is not required to reg-
ister). 
‘‘(C) The vendor agrees to cooperate with all bi-
ological implant recalls conducted on the initiative of 
the vendor, on the initiative of the original product 
manufacturer used by the vendor, by the request of 
the Food and Drug Administration, or by a statu-
tory order of the Food and Drug Administration. 
‘‘(D) The vendor agrees to notify the Secretary 
of any adverse event report it provides to the Food 
and Drug Administration as required under part 
803 of title 21, Code of Federal Regulations, or any 
successor regulation, or any warning letter from the 
Food and Drug Administration issued to the vendor 
or the original product manufacturer used by the 
vendor by not later than 60 days after the vendor 
receives such report or warning letter. 
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