Document

Revocation of Authorization of Emergency Use of ExThera Medical Corporation Seraph 100 Microbind Affinity Blood Filter (Seraph 100); Availability

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to ExThera Medical Corporation, for the S...

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Department of Health and Human Services

Food and Drug Administration

[Docket No. FDA-2026-N-1309]

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 ExThera Medical Corporation, for the Seraph 100 Microbind Affinity Blood Filter (Seraph 100). 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.

DATES:

The revocation of the Authorization for the ExThera Medical Corporation Seraph 100 Microbind Affinity Blood Filter (Seraph 100) is effective as of November 24, 2025.

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. 5441, 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:

Michael Hoffman, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2410, Silver Spring, MD 20993-0002, 301-796-6476 (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 17, 2020, FDA issued the Authorization to ExThera Medical Corporation, for the Seraph 100 Microbind Affinity Blood Filter (Seraph 100), 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 October 21, 2025, ExThera Medical Corporation, requested the withdrawal of, and on November 24, 2025, FDA revoked, the Authorization for the ExThera Medical Corporation's Seraph 100 Microbind Affinity Blood Filter (Seraph 100). ExThera Medical Corporation notified FDA that as of the date of this revocation, no viable Seraph 100 Microbind Affinity Blood Filter (Seraph 100) remained under EUA ( printed page 8009) distribution and requested FDA withdraw the ExThera Medical Corporation's Seraph 100 Microbind Affinity Blood Filter (Seraph 100). 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 ExThera Medical Corporation's Seraph 100 Microbind Affinity Blood Filter (Seraph 100). 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.

( printed page 8010)

Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.

BILLING CODE 4164-01-P

[FR Doc. 2026-03250 Filed 2-18-26; 8:45 am]

BILLING CODE 4164-01-C

Legal Citation

Federal Register Citation

Use this for formal legal and research references to the published document.

91 FR 8008

Web Citation

Suggested Web Citation

Use this when citing the archival web version of the document.

“Revocation of Authorization of Emergency Use of ExThera Medical Corporation Seraph 100 Microbind Affinity Blood Filter (Seraph 100); Availability,” thefederalregister.org (February 19, 2026), https://thefederalregister.org/documents/2026-03250/revocation-of-authorization-of-emergency-use-of-exthera-medical-corporation-seraph-100-microbind-affinity-blood-filter-s.