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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medical Device Recall 
Improvement Act’’. 
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SEC. 2. REGULATION OF MEDICAL DEVICE RECALLS. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.), is amended by inserting after 
section 518A of such Act the following: 
‘‘SEC. 518B. ELECTRONIC NOTIFICATION FORMAT FOR DE-
VICE RECALLS. 
‘‘(a) ELECTRONIC NOTIFICATION FORMAT FOR DE-
VICE RECALLS.— 
‘‘(1) IN
GENERAL.—Not later than 2 years 
after the date of enactment of the Medical Device 
Recall Improvement Act, the Secretary shall publish 
a form and manner for notifications of a recall. 
‘‘(2) CONTENT.—The form and manner pre-
scribed by the Secretary under paragraph (1) 
shall— 
‘‘(A) be electronic; 
‘‘(B) include mandatory data elements, in-
cluding— 
‘‘(i) the name of the manufacturer or 
importer; 
‘‘(ii) the contact information and ad-
dress of the manufacturer or importer; 
‘‘(iii) the specific reason for the cor-
rection or removal from the market of the 
device; 
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‘‘(iv) the specific device of the manu-
facturer or importer subject to such recall; 
‘‘(v) the unique device identifier of the 
device, including, as applicable, the device 
identifier and any production identifier; 
‘‘(vi) information for device user fa-
cilities and health professionals with re-
gard to the device and such recall; and 
‘‘(vii) information for patients with re-
gard to the device and such recall, includ-
ing— 
‘‘(I) the risk presented by the de-
vice; and 
‘‘(II) any action that may be 
taken by, or on behalf of, such pa-
tients to eliminate or reduce such risk; 
and 
‘‘(C) include optional data elements as the 
Secretary determines to be appropriate. 
‘‘(b) NOTIFICATIONS.— 
‘‘(1) NOTIFICATIONS TO THE SECRETARY.— 
‘‘(A) IN GENERAL.—Beginning 180 days 
after the Secretary establishes the form and 
manner for recall notifications under subsection 
(a), a manufacturer or importer of a device 
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shall submit notifications required under section 
519(g) to the Secretary through the electronic 
notification format established under subsection 
(a). 
‘‘(B) REVIEW REQUIREMENT.— 
‘‘(i) INITIAL REVIEW.—Not later than 
2 business days after receipt of a notifica-
tion described in subparagraph (A), the 
Secretary shall conduct an initial review of 
such notification. 
‘‘(ii) 
RESPONSE
OF
THE
SEC-
RETARY.—Not later than 3 business days 
after the completion of such review, the 
Secretary shall inform the manufacturer or 
importer of the information the Secretary 
determines, through the initial review 
under clause (i), should be shared with de-
vice user facilities and health professionals. 
‘‘(2) NOTIFICATIONS TO DEVICE USER FACILI-
TIES AND HEALTH PROFESSIONALS.— 
‘‘(A) INITIAL
NOTIFICATIONS.—A manu-
facturer or importer shall submit notifications 
to device user facilities and health professionals 
through the electronic notification format estab-
lished under subsection (a) after an initial re-
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view by the Secretary is completed under para-
graph (1)(B)(i). 
‘‘(B) 
SUBSEQUENT
NOTIFICATIONS.—A 
manufacturer or importer shall provide notifica-
tions in addition to those described in subpara-
graph (A), as necessary, to device user facilities 
or health professionals through the electronic 
notification format established under subsection 
(a). 
‘‘(c) ELECTRONIC DATABASE.—The Secretary shall 
maintain an electronic database that is publicly accessible, 
downloadable, and populated with information regarding 
device notifications made under this section. 
‘‘(d) DEFINITIONS.—In this section and in section 
518C— 
‘‘(1) the term ‘device user facility’ has the 
meaning given such term in section 519(b)(6); and 
‘‘(2) the term ‘recall’ has the meaning given 
such term in section 518A. 
‘‘(e) AUTHORIZATION
OF
APPROPRIATIONS.—For 
purposes of conducting activities under this section and 
hiring personnel to conduct such activities, there is au-
thorized to be appropriated $6,700,000 for fiscal year 
2024, $1,700,000 for fiscal year 2025, and $1,000,000 
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for each of fiscal years 2026 through 2028, to remain 
available until expended, without fiscal year limitation. 
‘‘SEC. 518C. PATIENT NOTIFICATION. 
‘‘(a) IN GENERAL.—The Secretary shall require that 
any recall strategy under section 519(g) provides for no-
tice to patients whom device user facilities and health pro-
fessionals treated with the device. 
‘‘(b) COMPLIANCE.—In accordance with subsection 
(a), the Secretary shall require recall notifications sent 
from the manufacturer or importer of the device to— 
‘‘(1) include information for device user facili-
ties and health professionals about the risks pre-
sented by the device to patients whom device user 
facilities and health professionals treated with the 
device; and 
‘‘(2) instruct such device user facilities and 
health professionals to share information under 
paragraph (1) with patients whom device user facili-
ties and health professionals treated with the device. 
‘‘(c) AFFECTED
DEVICES.—Subsection (a) shall 
apply with respect to any class I or class II recall for a 
class II or class III device that is used outside of device 
user facilities and— 
‘‘(1) implanted in the human body; 
‘‘(2) life-sustaining; 
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‘‘(3) life-supporting; or 
‘‘(4) used significantly in pediatric populations. 
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to require device user facilities or 
health professionals to provide patient information to the 
manufacturer or importer of the device.’’. 
SEC. 3. PROHIBITED ACTS. 
Section 301 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 331) is amended by adding at the end the 
following: 
‘‘(jjj) The refusal or failure to submit notifications 
in accordance with paragraphs (1) and (2) of section 
518B(b). 
‘‘(kkk) The refusal or failure to provide notice in ac-
cordance with section 518C.’’. 
Æ 
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