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###### Department of Health and Human Services

###### Food and Drug Administration

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

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice.

# 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.

      ( print 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.
      ( print page 100511)          ( print page 100512)    

Dated: December 4, 2024.

P. Ritu Nalubola,

Associate Commissioner for Policy.

BILLING CODE 4164-01-P

[FR Doc. 2024-29247 Filed 12-11-24; 8:45 am]

BILLING CODE 4164-01-C