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