Title: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to notifications of emerging signals concerning devices.
Policy area: Health

Summary:
This bill establishes certain requirements relating to the Food and Drug Administration's (FDA's) public notices on the potential new risks of approved medical devices (i.e., emerging signals), including with respect to the standards of evidence needed for such notices. The FDA must update its current guidance on emerging signals to align with the bill's requirements.

[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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