I 

118TH CONGRESS 

1ST SESSION H. R. 5662 

To improve medical device recall notifications by amending the Federal Food, 

Drug, and Cosmetic Act to establish an electronic format for device 

recall notifications, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 21, 2023 

Ms. SCHAKOWSKY introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL 

To improve medical device recall notifications by amending 

the Federal Food, Drug, and Cosmetic Act to establish 

an electronic format for device recall notifications, and 

for other purposes. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medical Device Recall 

5 Improvement Act’’. 


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1 SEC. 2. REGULATION OF MEDICAL DEVICE RECALLS. 

2 Chapter V of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 351 et seq.), is amended by inserting after 

4 section 518A of such Act the following: 

5 ‘‘SEC. 518B. ELECTRONIC NOTIFICATION FORMAT FOR DE6 VICE RECALLS. 

7 ‘‘(a) ELECTRONIC NOTIFICATION FORMAT FOR DE8 VICE RECALLS.— 

9 ‘‘(1) IN GENERAL.—Not later than 2 years 

10 after the date of enactment of the Medical Device 

11 Recall Improvement Act, the Secretary shall publish 

12 a form and manner for notifications of a recall. 

13 ‘‘(2) CONTENT.—The form and manner pre14 scribed by the Secretary under paragraph (1) 

15 shall— 

16 ‘‘(A) be electronic; 

17 ‘‘(B) include mandatory data elements, in18 cluding— 

19 ‘‘(i) the name of the manufacturer or 

20 importer; 

21 ‘‘(ii) the contact information and ad22 dress of the manufacturer or importer; 

23 ‘‘(iii) the specific reason for the cor24 rection or removal from the market of the 

25 device; 


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1 ‘‘(iv) the specific device of the manu2 facturer or importer subject to such recall; 

3 ‘‘(v) the unique device identifier of the 

4 device, including, as applicable, the device 

5 identifier and any production identifier; 

6 ‘‘(vi) information for device user fa7 cilities and health professionals with re8 gard to the device and such recall; and 

9 ‘‘(vii) information for patients with re10 gard to the device and such recall, includ11 ing— 

12 ‘‘(I) the risk presented by the de13 vice; and 

14 ‘‘(II) any action that may be 

15 taken by, or on behalf of, such pa16 tients to eliminate or reduce such risk; 

17 and 

18 ‘‘(C) include optional data elements as the 

19 Secretary determines to be appropriate. 

20 ‘‘(b) NOTIFICATIONS.— 

21 ‘‘(1) NOTIFICATIONS TO THE SECRETARY.— 

22 ‘‘(A) IN GENERAL.—Beginning 180 days 

23 after the Secretary establishes the form and 

24 manner for recall notifications under subsection 

25 (a), a manufacturer or importer of a device 


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1 shall submit notifications required under section 

2 519(g) to the Secretary through the electronic 

3 notification format established under subsection 

4 (a). 

5 ‘‘(B) REVIEW REQUIREMENT.— 

6 ‘‘(i) INITIAL REVIEW.—Not later than 

7 2 business days after receipt of a notifica8 tion described in subparagraph (A), the 

9 Secretary shall conduct an initial review of 

10 such notification. 

11 ‘‘(ii) RESPONSE OF THE SEC12 RETARY.—Not later than 3 business days 

13 after the completion of such review, the 

14 Secretary shall inform the manufacturer or 

15 importer of the information the Secretary 

16 determines, through the initial review 

17 under clause (i), should be shared with de18 vice user facilities and health professionals. 

19 ‘‘(2) NOTIFICATIONS TO DEVICE USER FACILI20 TIES AND HEALTH PROFESSIONALS.— 

21 ‘‘(A) INITIAL NOTIFICATIONS.—A manu22 facturer or importer shall submit notifications 

23 to device user facilities and health professionals 

24 through the electronic notification format estab25 lished under subsection (a) after an initial reVerDate Sep 11 2014 01:07 Sep 27, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5662.IH H5662

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1 view by the Secretary is completed under para2 graph (1)(B)(i). 

3 ‘‘(B) SUBSEQUENT NOTIFICATIONS.—A 

4 manufacturer or importer shall provide notifica5 tions in addition to those described in subpara6 graph (A), as necessary, to device user facilities 

7 or health professionals through the electronic 

8 notification format established under subsection 

9 (a). 

10 ‘‘(c) ELECTRONIC DATABASE.—The Secretary shall 

11 maintain an electronic database that is publicly accessible, 

12 downloadable, and populated with information regarding 

13 device notifications made under this section. 

14 ‘‘(d) DEFINITIONS.—In this section and in section 

15 518C— 

16 ‘‘(1) the term ‘device user facility’ has the 

17 meaning given such term in section 519(b)(6); and 

18 ‘‘(2) the term ‘recall’ has the meaning given 

19 such term in section 518A. 

20 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For 

21 purposes of conducting activities under this section and 

22 hiring personnel to conduct such activities, there is au23 thorized to be appropriated $6,700,000 for fiscal year 

24 2024, $1,700,000 for fiscal year 2025, and $1,000,000 


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1 for each of fiscal years 2026 through 2028, to remain 

2 available until expended, without fiscal year limitation. 

3 ‘‘SEC. 518C. PATIENT NOTIFICATION. 

4 ‘‘(a) IN GENERAL.—The Secretary shall require that 

5 any recall strategy under section 519(g) provides for no6 tice to patients whom device user facilities and health pro7 fessionals treated with the device. 

8 ‘‘(b) COMPLIANCE.—In accordance with subsection 

9 (a), the Secretary shall require recall notifications sent 

10 from the manufacturer or importer of the device to— 

11 ‘‘(1) include information for device user facili12 ties and health professionals about the risks pre13 sented by the device to patients whom device user 

14 facilities and health professionals treated with the 

15 device; and 

16 ‘‘(2) instruct such device user facilities and 

17 health professionals to share information under 

18 paragraph (1) with patients whom device user facili19 ties and health professionals treated with the device. 

20 ‘‘(c) AFFECTED DEVICES.—Subsection (a) shall 

21 apply with respect to any class I or class II recall for a 

22 class II or class III device that is used outside of device 

23 user facilities and— 

24 ‘‘(1) implanted in the human body; 

25 ‘‘(2) life-sustaining; 


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1 ‘‘(3) life-supporting; or 

2 ‘‘(4) used significantly in pediatric populations. 

3 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec4 tion shall be construed to require device user facilities or 

5 health professionals to provide patient information to the 

6 manufacturer or importer of the device.’’. 

7 SEC. 3. PROHIBITED ACTS. 

8 Section 301 of the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 331) is amended by adding at the end the 

10 following: 

11 ‘‘(jjj) The refusal or failure to submit notifications 

12 in accordance with paragraphs (1) and (2) of section 

13 518B(b). 

14 ‘‘(kkk) The refusal or failure to provide notice in ac15 cordance with section 518C.’’. 

Æ 


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