II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. NOTIFICATION WITH RESPECT TO POTEN4 TIALLY HARMFUL DEVICES. 

5 Section 518(a) of the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 360h(a)) is amended by adding at 

7 the end the following: 

8 ‘‘(3)(A) This paragraph applies in the event that the 

9 Secretary— 


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1 ‘‘(i) determines that a device meets the condi2 tions described in paragraph (1), but there are no 

3 more practicable means available under the provi4 sions of this Act (other than this section) to elimi5 nate the risk described in paragraph (1), and the no6 tification described in paragraph (2) will not provide 

7 a timely and practicable means to eliminate such 

8 risk; or 

9 ‘‘(ii) otherwise determines that it is necessary 

10 to notify the public about an emerging signal con11 cerning a device in order to reduce or limit the num12 ber of patients exposed to a potential risk identified 

13 based on an emerging signal. 

14 ‘‘(B) For purposes of this paragraph, the term 

15 ‘emerging signal’ mean new information about a marketed 

16 device— 

17 ‘‘(i) that supports a new causal association or 

18 a new aspect of a known association between a de19 vice and an adverse event or set of adverse events; 

20 and 

21 ‘‘(ii) for which the Secretary has conducted an 

22 initial evaluation and determined that the informa23 tion has the potential to impact patient management 

24 decisions or the known benefit-risk profile of the de25 vice. 


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1 ‘‘(C) In considering and taking actions under this 

2 section, the Secretary shall— 

3 ‘‘(i) to the extent possible, rely solely on valid 

4 scientific evidence; and 

5 ‘‘(ii) in any event, base its actions on credible 

6 scientific evidence, such that information that is 

7 unconfirmed, unreliable, or lacks sufficient strength 

8 of evidence shall not constitute an emerging signal 

9 or otherwise provide a basis for notification. 

10 ‘‘(D) In the circumstances described in subparagraph 

11 (A), the Secretary may issue a public notification subject 

12 to the following procedures: 

13 ‘‘(i) Any public notification under this para14 graph shall include a description of the device or de15 vices to which the notification applies, and shall re16 flect a totality of the evidence on which the notifica17 tion is based and information about the known bene18 fits and risks of the device or devices, including in19 formation available from the manufacturer or manu20 facturers. 

21 ‘‘(ii) To the extent credible scientific evidence is 

22 presented to the Secretary that contradicts or modi23 fies the information that serves as a potential basis 

24 for a notification, the Secretary shall include such 

25 scientific evidence in the public notification in a 


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1 manner that provides the intended audience with a 

2 complete understanding of the overall nature of in3 formation concerning the potential risk. 

4 ‘‘(iii) Prior to issuance of the public notifica5 tion, the Secretary shall— 

6 ‘‘(I) inform the manufacturer or manufac7 turers of the device or devices at issue, and pro8 vide the manufacturers the credible scientific 

9 evidence that is the basis for considering a pub10 lic notification and the Secretary’s initial eval11 uation of such evidence as described in subpara12 graph (B)(ii); 

13 ‘‘(II) to the extent the Secretary deter14 mines that any of the credible scientific evi15 dence described in subclause (I) cannot be pro16 vided to manufacturers because such evidence 

17 constitutes confidential commercial information 

18 or trade secret information, the Secretary shall 

19 provide the manufacturers of the device or de20 vices at issue with a description of the withheld 

21 evidence to the extent permissible by law and 

22 also generally describe the basis for withholding 

23 such evidence; and 

24 ‘‘(III) provide the manufacturers of the de25 vice or devices at issue an adequate opportunity 


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1 to comment as to the nature of the potential 

2 risk and the manner and content of an applica3 ble notification, to share information about the 

4 potential risk, and to offer recommendations as 

5 to the form and content of the proposed notifi6 cation, including consideration of alternative 

7 forms of notification and risk mitigation, and 

8 the Secretary shall consider such input from the 

9 manufacturers before issuing a public notifica10 tion. 

11 ‘‘(iv) Provide periodic and timely updates to the 

12 notification based on new information or contrary 

13 information, including affirmative notice in the event 

14 that the emerging signal or other source of potential 

15 risk has been determined not to apply or has other16 wise been resolved or mitigated, such that no addi17 tional actions are required. Information provided by 

18 manufacturers subsequent to the initial public notifi19 cation should be considered by the Secretary for 

20 purposes of providing updates. 

21 ‘‘(v) With regard to information provided by 

22 manufacturers, the Secretary shall inform such man23 ufacturers how such information affects or alters the 

24 Secretary’s initial evaluation and whether the notifiVerDate Sep 11 2014 23:04 Jun 06, 2022 Jkt 029200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S4349.IS S4349

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1 cation will be updated or rescinded as a result of 

2 such information. 

3 ‘‘(vi) At least every 6 months after issuance, 

4 the Secretary shall evaluate current credible sci5 entific evidence to determine if a public notification 

6 should be rescinded, and if such determination is 

7 made, promptly provide notice of the rescission to 

8 the same audience and in the same manner as the 

9 original notification. 

10 ‘‘(E) Not later than September 30, 2023, the Sec11 retary shall revise the Food and Drug Administration 

12 guidance titled ‘Public Notification of Emerging 

13 Postmarket Medical Device Signals (‘‘Emerging Sig14 nals’’)’, to conform with this subsection. 

15 ‘‘(F) Not later than September 30, 2023, the Sec16 retary shall submit to the Committee on Health, Edu17 cation, Labor, and Pensions of the Senate and the Com18 mittee on Energy and Commerce of the House of Rep19 resentatives a report regarding how patients, providers, 

20 and the public interpret and comprehend risk-related in21 formation provided or ordered by the Secretary relating 

22 to devices, including reports under this section, notifica23 tions concerning recalls, and notifications concerning ad24 verse events, and whether the relative level of risk and apVerDate Sep 11 2014 23:04 Jun 06, 2022 Jkt 029200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S4349.IS S4349

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1 propriate mitigation for such risk are adequately under2 stood. 

3 ‘‘(G) To the extent the Secretary seeks to rely on 

4 data, analysis, or other information or findings provided 

5 by third parties that has been funded in whole or in part 

6 by, or otherwise performed under contract with, the Food 

7 and Drug Administration in making significant decisions 

8 concerning devices or considering issuance of orders under 

9 this section or section 522, the Secretary shall— 

10 ‘‘(i) obtain access to the raw datasets, inputs, 

11 clinical or other assumptions, methods, analytical 

12 code, results, and other components underlying or 

13 comprising the analysis, conclusions or other find14 ings upon which the Secretary seeks to rely; and 

15 ‘‘(ii) in the event a significant decision is made, 

16 or an order under this section or section 522 is 

17 under consideration, in reliance on such information 

18 or findings, provide the manufacturer or manufac19 turers subject to such decision or order the informa20 tion or findings, including the underlying informa21 tion described in paragraph (1), except that any 

22 such underlying information that the Secretary de23 termines to be confidential commercial information 

24 or trade secret information may be withheld but 


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1 shall be described to the manufacturer or manufac2 turers to the extent permissible by law.’’. 

Æ 


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