Notice2026-03250
Revocation of Authorization of Emergency Use of ExThera Medical Corporation Seraph 100 Microbind Affinity Blood Filter (Seraph 100); Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 19, 2026
Effective
November 24, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 91 Issue 33 (Thursday, February 19, 2026)</title>
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[Federal Register Volume 91, Number 33 (Thursday, February 19, 2026)]
[Notices]
[Pages 8008-8010]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03250]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-1309]
Revocation of Authorization of Emergency Use of ExThera Medical
Corporation Seraph 100 Microbind Affinity Blood Filter (Seraph 100);
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 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
[[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 <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.
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.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TN19FE26.000
[[Page 8010]]
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-03250 Filed 2-18-26; 8:45 am]
BILLING CODE 4164-01-C
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</html>Indexed from Federal Register on February 19, 2026.
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