II 117th CONGRESS 2d Session S. 4349 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.

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. .