,,ii #aagth ,,congress #b;d ,session ,s4 #dcdi ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #f1 #bjbb,mr4 ,marshall 7for himself and ,mr4 ,braun7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act with respect to notifications of emerging signals concerning devices4 #a4 ,notification with respect to potentially harmful devices ,section #eah7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;h7a77 is amended by adding at the end the following3 7#c7 7,a7 ,this paragraph applies in the event that the ,secretary-- 7i7 determines that a device meets the conditions described in paragraph 7#a71 but there are no more practicable means available under the provisions of this ,act 7other than this section7 to eliminate the risk described in paragraph 7#a71 and the notification described in paragraph 7#b7 will not provide a timely and practicable means to eliminate such risk2 or 7ii7 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 signal4 7,b7 ,for purposes of this paragraph1 the term emerging signal mean new information about a marketed device-- 7i7 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 events2 and 7ii7 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 device4 7,c7 ,in considering and taking actions under this section1 the ,secretary shall-- 7i7 to the extent possible1 rely solely on valid scientific evidence2 and 7ii7 in any event1 base its actions on credible scientific evidence1 such that information that is unconfirmed1 unreliable1 or lacks sufficient strength of evidence shall not constitute an emerging signal or otherwise provide a basis for notification4 7,d7 ,in the circumstances described in subparagraph 7,a71 the ,secretary may issue a public notification subject to the following procedures3 7i7 ,any public notification under this paragraph shall include a description of the device or devices to which the notification applies1 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 devices1 including information available from the manufacturer or manufacturers4 7ii7 ,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 notification1 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 risk4 7iii7 ,prior to issuance of the public notification1 the ,secretary shall-- 7,i7 inform the manufacturer or manufacturers of the device or devices at issue1 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 7,b77ii72 7,,ii7 to the extent the ,secretary determines that any of the credible scientific evidence described in subclause 7,i7 cannot be provided to manufacturers because such evidence constitutes confidential commercial information or trade secret information1 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 evidence2 and 7,,iii7 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 notification1 to share information about the potential risk1 and to offer recommendations as to the form and content of the proposed notification1 including consideration of alternative forms of notification and risk mitigation1 and the ,secretary shall consider such input from the manufacturers before issuing a public notification4 7iv7 ,provide periodic and timely updates to the notification based on new information or contrary information1 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 mitigated1 such that no additional actions are required4 ,information provided by manufacturers subsequent to the initial public notification should be considered by the ,secretary for purposes of providing updates4 7v7 ,with regard to information provided by manufacturers1 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 information4 7vi7 ,at least every #f months after issuance1 the ,secretary shall evaluate current credible scientific evidence to determine if a public notification should be rescinded1 and if such determination is made1 promptly provide notice of the rescission to the same audience and in the same manner as the original notification4 7,e7 ,not later than ,september #cj1 #bjbc1 the ,secretary shall revise the ,food and ,drug ,administration guidance titled ,public ,notification of ,emerging ,postmarket ,medical ,device ,signals 7,emerging ,signals71 to conform with this subsection4 7,f7 ,not later than ,september #cj1 #bjbc1 the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report regarding how patients1 providers1 and the public interpret and comprehend risk-related information provided or ordered by the ,secretary relating to devices1 including reports under this section1 notifications concerning recalls1 and notifications concerning adverse events1 and whether the relative level of risk and appropriate mitigation for such risk are adequately understood4 7,g7 ,to the extent the ,secretary seeks to rely on data1 analysis1 or other information or findings provided by third parties that has been funded in whole or in part by1 or otherwise performed under contract with1 the ,food and ,drug ,administration in making significant decisions concerning devices or considering issuance of orders under this section or section #ebb1 the ,secretary shall-- 7i7 obtain access to the raw datasets1 inputs1 clinical or other assumptions1 methods1 analytical code1 results1 and other components underlying or comprising the analysis1 conclusions or other findings upon which the ,secretary seeks to rely2 and 7ii7 in the event a significant decision is made1 or an order under this section or section #ebb is under consideration1 in reliance on such information or findings1 provide the manufacturer or manufacturers subject to such decision or order the information or findings1 including the underlying information described in paragraph 7#a71 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 law4 4