Bill Summary
The "Medical Device Recall Improvement Act of 2025" aims to enhance the process of notifying the public about medical device recalls by amending the Federal Food, Drug, and Cosmetic Act. Key provisions include:
1. **Electronic Notification Requirement**: The Act mandates the establishment of an electronic format for manufacturers and importers to submit recall notifications to the Secretary of Health and Human Services within two years of enactment. This format must include essential information such as the manufacturer's details, the reason for the recall, and specific device identifiers.
2. **Timely Review and Communication**: The Secretary is required to conduct an initial review of submitted notifications within two business days and inform manufacturers about what information should be shared with healthcare facilities and professionals within an additional three days.
3. **Patient Notifications**: The Act requires that recall strategies include provisions for notifying patients who have received affected devices, ensuring they are informed of any risks and necessary actions.
4. **Public Database**: An electronic database will be maintained by the Secretary, which will be publicly accessible and downloadable, containing information about the recalls.
5. **Funding Authorization**: The Act authorizes appropriations to support the implementation of these requirements.
6. **Prohibitions**: It establishes penalties for manufacturers and importers who fail to comply with the new notification requirements.
Overall, the legislation is designed to streamline and improve the recall process for medical devices, enhancing patient safety and communication.
Possible Impacts
The "Medical Device Recall Improvement Act of 2025" could affect people in various ways, including:
1. **Improved Awareness of Device Risks**: Patients and healthcare providers will receive timely notifications about recalls through an electronic format, which will enhance their awareness of potential risks associated with medical devices. This could lead to quicker actions taken by patients and healthcare providers to mitigate risks, ultimately improving patient safety.
2. **Enhanced Communication between Manufacturers and Healthcare Providers**: The requirement for manufacturers to provide detailed information about device recalls electronically ensures that healthcare professionals are better informed about the devices they use in patient care. This can lead to more informed decision-making regarding the use of specific devices, ensuring that healthcare providers can make appropriate adjustments in treatment plans.
3. **Streamlined Recall Process**: By establishing a standard electronic notification format and a publicly accessible database, the legislation facilitates a more efficient recall process. This could lead to quicker identification and resolution of issues related to defective medical devices, reducing the time that unsafe devices remain on the market, and ultimately protecting public health.
[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.''.
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