(b) EMERGING SIGNALS.—Section 518(a) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360h(a)), 
as amended by subsection (a), is further amended by add-
ing at the end the following: 
‘‘(2) EMERGING SIGNALS AND OTHER NOTIFI-
CATIONS.— 
‘‘(A) APPLICABILITY.—This paragraph ap-
plies if the Secretary— 
‘‘(i) determines that a device meets 
the conditions described in paragraph 
(1)(A), and no more practicable means is 
available under the provisions of this Act, 
including paragraph (1), to eliminate the 
risk described in paragraph (1)(A); or 
‘‘(ii) otherwise determines that it is 
necessary to notify the public about an 
emerging signal concerning a device in 
order to reduce or limit the number of pa-
tients exposed to a potential risk identified 
based on an emerging signal. 
‘‘(B) DEFINITION OF EMERGING SIGNAL.— 
In this paragraph, the term ‘emerging signal’ 
means new information about a marketed de-
vice— 
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‘‘(i) that supports a new causal asso-
ciation or a new aspect of a known associa-
tion between the device and an adverse 
event or set of adverse events; and 
‘‘(ii) for which the Secretary has con-
ducted an initial evaluation and deter-
mined that the information has the poten-
tial to impact patient management deci-
sions or the known benefit-risk profile of 
the device. 
‘‘(C) 
RELIANCE
ON
SCIENTIFIC
EVI-
DENCE.—In considering and taking actions 
under this section, the Secretary shall— 
‘‘(i) to the extent possible, rely solely 
on valid scientific evidence; and 
‘‘(ii) in any event, base such actions 
on credible scientific evidence, such that 
information that is unconfirmed, unreli-
able, or lacks sufficient strength of evi-
dence shall not constitute an emerging sig-
nal or otherwise provide a basis for notifi-
cation under this paragraph. 
‘‘(D) CONTENT
OF
PUBLIC
NOTIFICA-
TION.—Any public notification under this para-
graph shall— 
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‘‘(i) include a description of the device 
or devices to which the notification applies; 
‘‘(ii) reflect a totality of the evidence 
on which the notification is based; and 
‘‘(iii) incorporate information about 
the known benefits and risks of the device 
or devices, including information available 
from the manufacturer or manufacturers. 
‘‘(E) CONTRADICTORY EVIDENCE.—To the 
extent credible scientific evidence is presented 
to the Secretary that contradicts or modifies 
the information that serves as a potential basis 
for a public notification under this paragraph, 
the Secretary shall include such scientific evi-
dence in the public notification in a manner 
that provides the intended audience with a com-
plete understanding of the overall nature of in-
formation concerning the potential risk. 
‘‘(F) OPPORTUNITY FOR MANUFACTURERS 
TO COMMENT.—Prior to issuance of a public 
notification under this paragraph, the Secretary 
shall— 
‘‘(i) provide the manufacturer or man-
ufacturers of the device or devices at issue 
the credible scientific evidence that is the 
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basis for considering the public notification 
and the Secretary’s initial evaluation of 
such evidence as described in subpara-
graph (B)(ii); 
‘‘(ii) to the extent the Secretary deter-
mines that any of the credible scientific 
evidence described in clause (i) cannot be 
provided to manufacturers because such 
evidence constitutes confidential commer-
cial information or trade secret informa-
tion, provide the manufacturer or manu-
facturers of the device or devices at issue 
with a description of the withheld evidence 
to the extent permissible by law and gen-
erally describe the basis for withholding 
such evidence; 
‘‘(iii) provide the manufacturer or 
manufacturers of the device or devices at 
issue an adequate opportunity— 
‘‘(I) to comment as to the nature 
of the potential risk and the manner 
and content of the potential notifica-
tion under this paragraph; 
‘‘(II) to share information about 
the potential risk; and 
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‘‘(III) to offer recommendations 
as to the form and content of the po-
tential notification, including consider-
ation of alternative forms of notifica-
tion and risk mitigation; and 
‘‘(iv) consider any input received 
under clause (iii). 
‘‘(G) UPDATES.—The Secretary shall pro-
vide periodic and timely updates to each notifi-
cation under this paragraph based on new in-
formation or contrary information, including af-
firmative notice in the event that the emerging 
signal or other source of potential risk has been 
determined not to apply or has otherwise been 
resolved or mitigated, such that no additional 
actions are required. For purposes of providing 
updates under this subparagraph, the Secretary 
shall consider information provided to the Sec-
retary by a manufacturer subsequent to the ini-
tial public notification. 
‘‘(H) RESPONSE
TO
INFORMATION
PRO-
VIDED BY MANUFACTURER.—With regard to in-
formation provided to the Secretary by a manu-
facturer relating to a notification under this 
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paragraph, the Secretary shall inform such 
manufacturer— 
‘‘(i) how such information affects or 
alters the Secretary’s initial evaluation; 
and 
‘‘(ii) whether the notification will be 
updated or rescinded as a result of such 
information. 
‘‘(I) PERIODIC
EVALUATION.—At least 
every six months after issuance of a notification 
under this paragraph, the Secretary shall— 
‘‘(i) evaluate current credible scientific 
evidence to determine if such notification 
should be rescinded; and 
‘‘(ii) if the Secretary determines such 
notification should be rescinded, promptly 
provide notice of the rescission to the same 
audience and in the same manner as the 
original notification. 
‘‘(J) REVISION OF GUIDANCE.—Not later 
than September 30, 2023, the Secretary shall 
revise the guidance of the Food and Drug Ad-
ministration 
titled 
‘Public 
Notification 
of 
Emerging Postmarket Medical Device Signals 
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