[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4349 Introduced in Senate (IS)]
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117th CONGRESS
2d Session
S. 4349
To amend the Federal Food, Drug, and Cosmetic Act with respect to
notifications of emerging signals concerning devices.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 6, 2022
Mr. Marshall (for himself and Mr. Braun) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to
notifications of emerging signals concerning devices.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. NOTIFICATION WITH RESPECT TO POTENTIALLY HARMFUL DEVICES.
Section 518(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360h(a)) is amended by adding at the end the following:
``(3)(A) This paragraph applies in the event that the Secretary--
``(i) determines that a device meets the conditions
described in paragraph (1), but there are no more practicable
means available under the provisions of this Act (other than
this section) to eliminate the risk described in paragraph (1),
and the notification described in paragraph (2) will not
provide a timely and practicable means to eliminate such risk;
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 patients exposed to a
potential risk identified based on an emerging signal.
``(B) For purposes of this paragraph, the term `emerging signal'
mean new information about a marketed device--
``(i) that supports a new causal association or a new
aspect of a known association between a device and an adverse
event or set of adverse events; and
``(ii) for which the Secretary has conducted an initial
evaluation and determined that the information has the
potential to impact patient management decisions or the known
benefit-risk profile of the device.
``(C) 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 its actions on credible
scientific evidence, such that information that is unconfirmed,
unreliable, or lacks sufficient strength of evidence shall not
constitute an emerging signal or otherwise provide a basis for
notification.
``(D) In the circumstances described in subparagraph (A), the
Secretary may issue a public notification subject to the following
procedures:
``(i) Any public notification under this paragraph shall
include a description of the device or devices to which the
notification applies, and shall reflect a totality of the
evidence on which the notification is based and information
about the known benefits and risks of the device or devices,
including information available from the manufacturer or
manufacturers.
``(ii) 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
notification, the Secretary shall include such scientific
evidence in the public notification in a manner that provides
the intended audience with a complete understanding of the
overall nature of information concerning the potential risk.
``(iii) Prior to issuance of the public notification, the
Secretary shall--
``(I) inform the manufacturer or manufacturers of
the device or devices at issue, and provide the
manufacturers the credible scientific evidence that is
the basis for considering a public notification and the
Secretary's initial evaluation of such evidence as
described in subparagraph (B)(ii);
``(II) to the extent the Secretary determines that
any of the credible scientific evidence described in
subclause (I) cannot be provided to manufacturers
because such evidence constitutes confidential
commercial information or trade secret information, the
Secretary shall provide the manufacturers of the device
or devices at issue with a description of the withheld
evidence to the extent permissible by law and also
generally describe the basis for withholding such
evidence; and
``(III) provide the manufacturers of the device or
devices at issue an adequate opportunity to comment as
to the nature of the potential risk and the manner and
content of an applicable notification, to share
information about the potential risk, and to offer
recommendations as to the form and content of the
proposed notification, including consideration of
alternative forms of notification and risk mitigation,
and the Secretary shall consider such input from the
manufacturers before issuing a public notification.
``(iv) Provide periodic and timely updates to the
notification based on new information or contrary information,
including affirmative 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. Information provided
by manufacturers subsequent to the initial public notification
should be considered by the Secretary for purposes of providing
updates.
``(v) With regard to information provided by manufacturers,
the Secretary shall inform such manufacturers how such
information affects or alters the Secretary's initial
evaluation and whether the notification will be updated or
rescinded as a result of such information.
``(vi) At least every 6 months after issuance, the
Secretary shall evaluate current credible scientific evidence
to determine if a public notification should be rescinded, and
if such determination is made, promptly provide notice of the
rescission to the same audience and in the same manner as the
original notification.
``(E) Not later than September 30, 2023, the Secretary shall revise
the Food and Drug Administration guidance titled `Public Notification
of Emerging Postmarket Medical Device Signals (``Emerging Signals'')',
to conform with this subsection.
``(F) Not later than September 30, 2023, the Secretary shall submit
to the Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives a report regarding how patients, providers, and the
public interpret and comprehend risk-related information provided or
ordered by the Secretary relating to devices, including reports under
this section, notifications concerning recalls, and notifications
concerning adverse events, and whether the relative level of risk and
appropriate mitigation for such risk are adequately understood.
``(G) To the extent the Secretary seeks to rely on data, analysis,
or other information or findings provided by third parties that has
been funded in whole or in part by, or otherwise performed under
contract with, the Food and Drug Administration in making significant
decisions concerning devices or considering issuance of orders under
this section or section 522, the Secretary shall--
``(i) obtain access to the raw datasets, inputs, clinical
or other assumptions, methods, analytical code, results, and
other components underlying or comprising the analysis,
conclusions or other findings upon which the Secretary seeks to
rely; and
``(ii) in the event a significant decision is made, or an
order under this section or section 522 is under consideration,
in reliance on such information or findings, provide the
manufacturer or manufacturers subject to such decision or order
the information or findings, including the underlying
information described in paragraph (1), except that any such
underlying information that the Secretary determines to be
confidential commercial information or trade secret information
may be withheld but shall be described to the manufacturer or
manufacturers to the extent permissible by law.''.
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