No official summary available for this bill.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3421 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 3421
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 SENATE OF THE UNITED STATES
December 10, 2025
Mr. Durbin introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
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.''.
<all>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S8625)
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