[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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