H.R. 6594

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6594 Introduced in House (IH)]

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119th CONGRESS
1st Session
H. R. 6594

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

December 10, 2025

Ms. Schakowsky (for herself and Mr. Carson) 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 Representatives 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 of 2025''.

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 DEVICE RECALLS.

``(a) Electronic Notification Format for Device Recalls.--
``(1) In general.--Not later than 2 years after the date of 
enactment of the Medical Device Recall Improvement Act of 2025, 
the Secretary shall publish a form and manner for notifications 
of a recall.
``(2) Content.--The form and manner prescribed by the 
Secretary under paragraph (1) shall--
``(A) be electronic;
``(B) include mandatory data elements, including--
``(i) the name of the manufacturer or 
importer;
``(ii) the contact information and address 
of the manufacturer or importer;
``(iii) the specific reason for the 
correction or removal from the market of the 
device;
``(iv) the specific device of the 
manufacturer 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 
facilities and health professionals with regard 
to the device and such recall; and
``(vii) information for patients with 
regard to the device and such recall, 
including--
``(I) the risk presented by the 
device; and
``(II) any action that may be taken 
by, or on behalf of, such patients 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 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 notification 
described in subparagraph (A), the Secretary 
shall conduct an initial review of such 
notification.
``(ii) Response of the secretary.--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 
device user facilities and health 
professionals.
``(2) Notifications to device user facilities and health 
professionals.--
``(A) Initial notifications.--A manufacturer or 
importer shall submit notifications to device user 
facilities and health professionals through the 
electronic notification format established under 
subsection (a) after an initial review by the Secretary 
is completed under paragraph (1)(B)(i).
``(B) Subsequent notifications.--A manufacturer or 
importer shall provide notifications in addition to 
those described in subparagraph (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 authorized to be appropriated $6,700,000 for 
fiscal year 2026, $1,700,000 for fiscal year 2027, and $1,000,000 for 
each of fiscal years 2028 through 2030, 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 notice to patients whom 
device user facilities and health professionals 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 facilities and 
health professionals about the risks presented 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 facilities 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;
``(3) life-supporting; or
``(4) used significantly in pediatric populations.
``(d) Rule of Construction.--Nothing in this section 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 accordance with 
section 518C.''.
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