[Congressional Record Volume 169, Number 153 (Thursday, September 21, 2023)]
[Senate]
[Page S4658]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DURBIN:
  S. 2907. 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; to the Committee on Health, Education, Labor, and Pensions.
  Mr. DURBIN. Madam President, I ask unanimous consent that the text of 
the bill be printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 2907

       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''.

     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, 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.

     ``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.''.

                          ____________________