‘‘(l) If it is a device with respect to which the manu-
facturer is in violation of the reporting requirement in sec-
tion 510(s) (relating to communications to foreign health 
care providers).’’. 
(b) REQUIREMENT.—Section 510 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360), as 
amended by section 2 of this Act, is further amended by 
adding at the end the following: 
‘‘(s) REPORTING REQUIREMENT FOR CERTAIN COM-
MUNICATIONS TO FOREIGN HEALTH CARE PROVIDERS.— 
‘‘(1) REQUIREMENT.—The manufacturer of a 
device that is marketed in interstate commerce shall 
give written notice to the Food and Drug Adminis-
tration of any communication described in para-
graph (2) not more than 5 calendar days after mak-
ing such communication. 
‘‘(2) COMMUNICATION DESCRIBED.—A commu-
nication is described in this paragraph if the com-
munication— 
‘‘(A) is made by the manufacturer of the 
device or an affiliate of the manufacturer; 
‘‘(B) relates to a change to the design of 
the device, a change to the recommended re-
processing protocols, if any, for the device, or a 
safety concern about the device; and 
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‘‘(C) is widely disseminated (including on a 
voluntary basis) to health care providers in a 
foreign country. 
‘‘(3) AFFILIATE.—In this subsection, the term 
‘affiliate’ means a business entity that has a rela-
tionship with a second business entity if, directly or 
indirectly— 
‘‘(A) one business entity controls, or has 
the power to control, the other business entity; 
or 
‘‘(B) a third party controls, or has the 
power to control, both of the business entities.’’. 
SEC. 4. RAPID ASSESSMENT TESTS INTENDED TO ENSURE 
PROPER REPROCESSING. 
(a) INCLUSION
IN DEVICE DEFINITION.—Section 
201 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321) is amended— 
(1) in paragraph (h)— 
(A) in subparagraph (2), by striking ‘‘or’’ 
at the end; 
(B) in subparagraph (3), by striking ‘‘and’’ 
at the end and inserting ‘‘or’’; and 
(C) by inserting after subparagraph (3) 
the following: 
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‘‘(4) a rapid assessment test intended to ensure 
the proper reprocessing of a reusable device (as de-
fined in paragraph (ss)), and’’; and 
(2) by adding at the end the following: 
‘‘(ss) The term ‘reusable device’ means a device 
that— 
‘‘(1) is intended to be used more than one time; 
and 
‘‘(2) must be sanitized (whether through clean-
ing, disinfection, or sterilization) to ensure that the 
device is safe and effective for such intended use.’’. 
(b) INSTRUCTIONS
FOR
USE
AND
VALIDATION 
DATA.—Section 510 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360), as amended by sections 2 and 
3 of this Act, is further amended by adding at the end 
the following: 
‘‘(t) INSTRUCTIONS
FOR
USE
AND
VALIDATION 
DATA.— 
‘‘(1) INITIAL LIST.—Not later than 1 year after 
the date of enactment of this subsection, the Sec-
retary shall by regulation develop and publish a list 
of types of rapid assessment tests described in sec-
tion 201(h)(4) for which reports under subsection 
(k) must include— 
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‘‘(A) instructions for use that have been 
validated in a manner specified by the Sec-
retary; and 
‘‘(B) validation data, of the types specified 
by the Secretary. 
‘‘(2) UPDATES.—The Secretary shall by regula-
tion periodically update the list required by para-
graph (1). 
‘‘(3) ENFORCEMENT.—Beginning on the date 
of publication of the initial list under paragraph (1), 
the Secretary shall not accept any notification under 
subsection (k) for clearance of a type of rapid as-
sessment test that is included on such list unless 
such notification includes instructions for use and 
validation data in accordance with paragraph (1).’’. 
Æ 
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