S. 2907Senate118th Congress (2023-2025)In Committee

Medical Device Recall Improvement Act

Introduced September 21, 2023

AI-Generated Summary

Updated January 20, 2026 at 11:40 AM UTC

The Medical Device Recall Improvement Act updates the Federal Food, Drug, and Cosmetic Act to require electronic recall notifications for medical devices. It sets a standard format with required information and creates a public online database. The law also mandates that patients be notified for certain high‑risk recalls. It applies to device manufacturers, importers, the FDA (Secretary), health‑care facilities, professionals, and patients.

Key Provisions

  • The FDA must publish an electronic recall‑notification form and procedures within two years of the law’s enactment.
  • Manufacturers and importers must submit recall notifications electronically within 180 days after the form is established, including mandatory data such as manufacturer contact, reason for recall, device identifier, and information for facilities, professionals, and patients.
  • The FDA must conduct an initial review of each electronic notification within two business days and inform the submitter of information to share with facilities and health professionals within three business days.
  • After FDA review, manufacturers must send the notification to device user facilities and health professionals through the electronic format, and provide updates as needed.
  • The FDA must maintain a publicly accessible, downloadable electronic database of all device recall notifications.
  • The Secretary must require that recall strategies include direct notice to patients for class I or II recalls of class II or III devices that are implanted, life‑sustaining, life‑supporting, or used significantly in pediatric populations.
  • It adds prohibited acts for failing to submit electronic notifications or to provide required patient notice, making such refusals subject to penalties under the FD&C Act.

Legislative Activity

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1 earlier action
SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S4658)

September 21, 2023

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SenateIntro Referral

Introduced in Senate

September 21, 2023

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S4658)

September 21, 2023

Floor Debate

2 members

What members said about S. 2907 on the floor

2 Democrats
Alex Padilla
Sen. Alex PadillaD-CA · Sep 21, 2023

Madam President, I rise to speak in support of the Opportunity to Address College Hunger Act, which I introduced today. According to a 2018 GAO study, roughly 2 million at-risk college students who…

Richard J. Durbin
Sen. Richard J. DurbinD-IL · Sep 21, 2023

Madam President, I ask unanimous consent that the text of the bill be printed in the Record.

Richard J. Durbin
Sen. Richard J. DurbinD-IL · Sep 21, 2023

Madam President, I ask unanimous consent that the text of the bill be printed in the Record.

Bill Text

Latest available legislative text

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Introduced in SenateIssued September 21, 2023

II

118th CONGRESS

1st Session

S. 2907

IN THE SENATE OF THE UNITED STATES

September 21, 2023

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.

1.

Short title

This Act may be cited as the Medical Device Recall Improvement Act.

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:

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, 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 2024, $1,700,000 for fiscal year 2025, and $1,000,000 for each of fiscal years 2026 through 2028, to remain available until expended, without fiscal year limitation.

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.

.

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.

.