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[Federal Register Volume 89, Number 239 (Thursday, December 12, 2024)]
[Notices]
[Pages 100509-100512]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29247]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-5375]

Revocation of Authorization of Emergency Use of B. Braun 
Medical's Perfusor Space Syringe Infusion Pump System, Infusomat Space 
Volumetric Infusion Pump System, and Outlook ES; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of the Emergency Use Authorization (EUA) (the Authorization) 
issued to B. Braun Medical, Inc., for the Perfusor Space Syringe 
Infusion Pump System, Infusomat Space Volumetric Infusion Pump System, 
and Outlook ES. FDA revoked this Authorization under the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization 
holder. The revocation, which includes an explanation of the reasons 
for revocation, is reprinted at the end of this document.

[[Page 100510]]

DATES: The revocation of the Authorization for the B. Braun Medical, 
Inc.'s Perfusor Space Syringe Infusion Pump System, Infusomat Space 
Volumetric Infusion Pump System, and Outlook ES is effective as of 
October 1, 2024.

ADDRESSES: Submit written requests for a single copy of the revocation 
to the Office of Policy, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 
5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive 
label to assist that office in processing your request or include a Fax 
number to which the revocation may be sent. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the revocation.

FOR FURTHER INFORMATION CONTACT: Jacqueline Gertz, Office of Product 
Evaluation and Quality, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 
3216, Silver Spring, MD 20993-0002, 240-402-9677 (this is not a toll-
free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the 
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and 
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5) 
allows FDA to strengthen the public health protections against 
biological, chemical, radiological, or nuclear agent or agents. Among 
other things, section 564 of the FD&C Act allows FDA to authorize the 
use of an unapproved medical product or an unapproved use of an 
approved medical product in certain situations. On April 11, 2020, FDA 
issued the Authorization to B. Braun Medical, Inc., for the Perfusor 
Space Syringe Infusion Pump System, Infusomat Space Volumetric Infusion 
Pump System, and Outlook ES, subject to the terms of the Authorization. 
Notice of the issuance of this Authorization was published in the 
Federal Register on July 14, 2020 (85 FR 42407), as required by section 
564(h)(1) of the FD&C Act.
    Subsequent updates to the Authorization were made available on 
FDA's website. The authorization of a device for emergency use under 
section 564 of the FD&C Act may, pursuant to section 564(g)(2) of the 
FD&C Act, be revoked when the criteria under section 564(c) of the FD&C 
Act for issuance of such authorization are no longer met (section 
564(g)(2)(B) of the FD&C Act), or other circumstances make such 
revocation appropriate to protect the public health or safety (section 
564(g)(2)(C) of the FD&C Act).

II. Authorization Revocation Request

    In a request received by FDA on August 6, 2024, B. Braun Medical, 
Inc., requested the withdrawal of, and on October 1, 2024, FDA revoked, 
the Authorization for the B. Braun Medical Inc.'s Perfusor Space 
Syringe Infusion Pump System, Infusomat Space Volumetric Infusion Pump 
System, and Outlook ES. Because B. Braun Medical Inc., notified FDA 
about the lack of customer interest and lack of need for use of the 
device for the indications granted under this EUA considering the 
improved COVID-19 situation and requested FDA withdraw the B. Braun 
Medical Inc.'s Perfusor Space Syringe Infusion Pump System, Infusomat 
Space Volumetric Infusion Pump System, and Outlook ES, FDA has 
determined that it is appropriate to protect the public health or 
safety to revoke this Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the 
revocation is available on the internet at https://www.regulations.gov/.

IV. The Revocation

    Having concluded that the criteria for revocation of the 
Authorization under section 564(g)(2)(C) of the FD&C Act are met, FDA 
has revoked the EUA of the B. Braun Medical Inc.'s Perfusor Space 
Syringe Infusion Pump System, Infusomat Space Volumetric Infusion Pump 
System, and Outlook ES. The revocation in its entirety follows and 
provides an explanation of the reasons for revocation, as required by 
section 564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P

[[Page 100511]]

[GRAPHIC] [TIFF OMITTED] TN12DE24.015

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[GRAPHIC] [TIFF OMITTED] TN12DE24.016

    Dated: December 4, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-29247 Filed 12-11-24; 8:45 am]
BILLING CODE 4164-01-C
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