```

[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5662 Introduced in House (IH)]

<DOC>

118th CONGRESS
  1st Session
                                H. R. 5662

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

                           September 21, 2023

Ms. Schakowsky 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''.

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.''.
                                 <all>
```