[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7646 Introduced in House (IH)]
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117th CONGRESS
2d Session
H. R. 7646
To amend the Federal Food, Drug, and Cosmetic Act to notify the public
about an emerging signal concerning a medical device in order to reduce
or limit the number of patients exposed to a potential risk identified
based on such emerging signal, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 3, 2022
Mr. Guthrie (for himself and Mr. Moulton) introduced the following
bill; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to notify the public
about an emerging signal concerning a medical device in order to reduce
or limit the number of patients exposed to a potential risk identified
based on such emerging signal, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Emerging Signals Modernization Act
of 2022''.
SEC. 2. PUBLIC NOTIFICATION OF AN EMERGING SIGNAL CONCERNING A MEDICAL
DEVICE.
(a) Technical Amendments.--Section 518 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360h) is amended--
(1) by striking the section designation and heading and
that follows through ``If the Secretary determines that--'' and
inserting the following:
``SEC. 518. NOTIFICATION AND OTHER REMEDIES.
``(a) Notification.--
``(1) In general.--If the Secretary determines that--'';
and
(2) in subsection (a)--
(A) by striking ``(1) a device'' and inserting the
following:
``(A) a device'';
(B) by striking ``(2) notification'' and inserting
the following:
``(B) notification'';
(C) by moving the margin of the continuation text
at the end of subsection (a) 2 ems to the right; and
(D) by striking ``this subsection'' each place it
appears and inserting ``this paragraph''.
(b) Emerging Signals.--Section 518(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360h(a)), as amended by subsection (a), is
further amended by adding at the end the following:
``(2) Emerging signals and other notifications.--
``(A) Applicability.--This paragraph applies 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 patients 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 device--
``(i) that supports a new causal
association or a new aspect of a known
association between the 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) Reliance on scientific evidence.--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, unreliable, or
lacks sufficient strength of evidence shall not
constitute an emerging signal or otherwise
provide a basis for notification under this
paragraph.
``(D) Content of public notification.--Any public
notification under this paragraph shall--
``(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 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.
``(F) Opportunity for manufacturers to comment.--
Prior to issuance of a public notification under this
paragraph, the Secretary shall--
``(i) provide the manufacturer or
manufacturers of the device or devices at issue
the credible scientific evidence that is the
basis for considering the 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 clause (i) cannot be
provided to manufacturers because such evidence
constitutes confidential commercial information
or trade secret information, provide the
manufacturer or manufacturers of the device or
devices at issue with a description of the
withheld evidence to the extent permissible by
law and generally 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
notification under this paragraph;
``(II) to share information about
the potential risk; and
``(III) to offer recommendations as
to the form and content of the
potential notification, including
consideration of alternative forms of
notification and risk mitigation; and
``(iv) consider any input received under
clause (iii).
``(G) Updates.--The Secretary shall provide
periodic and timely updates to each notification under
this paragraph 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. For purposes of providing updates
under this subparagraph, the Secretary shall consider
information provided to the Secretary by a manufacturer
subsequent to the initial public notification.
``(H) Response to information provided by
manufacturer.--With regard to information provided to
the Secretary by a manufacturer relating to a
notification under this 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 Administration titled
`Public Notification of Emerging Postmarket Medical
Device Signals (``Emerging Signals'')', to conform with
this paragraph.
``(K) Report to congress.--Not later than September
30, 2023, the Secretary shall submit to the Committee
on Energy and Commerce of the House of Representatives
and the Committee on Health, Education, Labor, and
Pensions of the Senate a report regarding--
``(i) how patients, health care 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
``(ii) whether the relative level of risk
and appropriate mitigations for such risk are
adequately understood.
``(L) Third party data transparency.--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 a significant decision
concerning one or more devices or considering issuance
of an order 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 data, analysis, or
other information or findings upon which the
Secretary seeks to rely; and
``(ii) if such a significant decision is
made, or such an order under this section or
section 522 is under consideration, in reliance
on such data, analysis, or other information or
findings, provide the manufacturer or
manufacturers subject to such decision or order
the data, analysis, or other information or
findings, including the underlying raw
datasets, inputs, clinical or other
assumptions, methods, analytical code, results,
and other components, except that any such raw
datasets, inputs, clinical or other
assumptions, methods, analytical code, results,
and other components 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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