Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID–19; Availability (Federal Register, August 31, 2021)
Summary
In this Federal Register notice of August 31, 2021, signed by Lauren K. Roth, Acting Principal Associate Commissioner for Emerging Threats, the Food and Drug Administration announces the revocation of the Emergency Use Authorization for the Curative SARS–Cov–2 Assay. FDA issued the authorization to Curative; it was originally issued to KorvaLabs under the name Curative-Korva SARS–Cov–2 Assay. Curative requested revocation on June 16, 2021 and told FDA it would stop using the assay as of July 15, 2021. FDA revoked the authorization effective July 15, 2021 under section 564(g)(2)(C) of the FD&C Act, which allows revocation when circumstances make it appropriate to protect the public health or safety. The notice reprints the full revocation with its explanation of reasons.
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48736 Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices
BILLING CODE 4164–01–C of the FD&C Act. The authorization of
ADDRESSES: Submit written requests for
Dated: August 26, 2021. a single copy of the revocation to the a device for emergency use under
Lauren K. Roth, Office of Counterterrorism and section 564 of the FD&C Act may,
Acting Principal Associate Commissioner for Emerging Threats, Food and Drug pursuant to section 564(g)(2)(C) of the
Policy. Administration, 10903 New Hampshire FD&C Act, be revoked when
[FR Doc. 2021–18777 Filed 8–30–21; 8:45 am] Ave., Bldg. 1, Rm. 4338, Silver Spring, circumstances make such revocation
MD 20993–0002. Send one self- appropriate to protect the public health
BILLING CODE 4164–01–P
addressed adhesive label to assist that or safety.
office in processing your request or
II. EUA Revocation Request of an In
DEPARTMENT OF HEALTH AND include a fax number to which the
Vitro Diagnostic Device
HUMAN SERVICES revocation may be sent. See the
SUPPLEMENTARY INFORMATION section for On June 16, 2021, Curative Inc.
Food and Drug Administration electronic access to the revocation. requested the revocation of, and on July
FOR FURTHER INFORMATION CONTACT:
15, 2021, FDA revoked, the
[Docket No. FDA–2021–N–0412] Jennifer J. Ross, Office of Authorization for the Curative SARS–
Counterterrorism and Emerging Threats, Cov–2 Assay. Because Curative Inc.
Revocation of Authorization of Food and Drug Administration, 10903 notified FDA that it will no longer be
Emergency Use of an In Vitro New Hampshire Ave., Bldg. 1, Rm. using the Curative SARS–Cov–2 Assay
Diagnostic Device for Detection and/or 4332, Silver Spring, MD 20993–0002, as of July 15, 2021, and requested FDA
Diagnosis of COVID–19; Availability 240–402–8155 (this is not a toll-free revoke the authorization effective that
number). day, FDA has determined that it is
AGENCY: Food and Drug Administration, appropriate to protect the public health
HHS. SUPPLEMENTARY INFORMATION: or safety to revoke this Authorization.
ACTION: Notice. I. Background III. Electronic Access
SUMMARY: The Food and Drug
Section 564 of the FD&C Act (21 An electronic version of this
Administration (FDA) is announcing the U.S.C. 360bbb-3) allows FDA to document and the full text of the
revocation of the Emergency Use strengthen the public health protections revocations are available on the internet
Authorization (EUA) (the Authorization) against biological, chemical, nuclear, at https://www.regulations.gov/ and
issued to Curative Inc. for the Curative and radiological agents. Among other https://www.fda.gov/media/150773/
SARS–Cov–2 Assay. FDA revoked the things, section 564 of the FD&C Act download.
Authorization on July 15, 2021, under allows FDA to authorize the use of an
IV. The Revocation
the Federal Food, Drug, and Cosmetic unapproved medical product or an
Act (FD&C Act), as requested by unapproved use of an approved medical Having concluded that the criteria for
Curative Inc. on June 16, 2021. The product in certain situations. On April revocation of the Authorization under
revocation, which includes an 16, 2020, FDA issued the Authorization section 564(g)(2)(C) of the FD&C Act are
explanation of the reasons for the to Curative Inc. (original issuance to met, FDA has revoked the EUA for the
revocation, is reprinted in this KorvaLabs, Inc. under the name Curative SARS–Cov–2 Assay. The
document. Curative-Korva SARS–Cov–2 Assay). revocation in its entirety follows and
Notice of the issuance of the provides an explanation of the reasons
DATES: The Authorization for the Authorization was published in the for revocation, as required by section
Curative SARS–Cov–2 Assay is revoked Federal Register on July 14, 2020 (85 FR 564(h)(1) of the FD&C Act.
as of July 15, 2021. 42407), as required by section 564(h)(1) BILLING CODE 4164–01–P
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Federal Register / Vol. 86, No. 166 / Tuesday, August 31, 2021 / Notices 48737
t/l-.. . .■ lJ.S. FOOD & DRUG
' .E .ADMINISTRAT-ION
July 15, 2021
Fred Turner
Chief Executive Officer
Curative· Inc.
1600 Adams Drive; Suite 105
Menlo Park, CA 94025
Re: Revocation ofEUA2(101l2
Deiµ- Mr.. Turner:.
This letteris in resporute to Curative• Inc.'s (Curative) requestdated June 16, 2021, that the U.S.
fo<>d and Drag Administta:uon (FDA) revoke the Emergency Use Ao.thmiia:til:m {EUA:200132)
for the Curative SARS-Cbv-2Assay iss.ued on April lG; 202(}, under the original nruneCurative-
Korva SARS-Covs2 Assay, and amended on June. I 1, 2020. As was also announced in its June
16, 2021 press-release, 1 Curati-ve has indicated that it ls transitioning_ to the use of different BUA-
authorized SARS-CoV-2 tests: forthe testing offered at its laboratories. In itsJune 16 letter,
Curative requested that the revocation of the Curative SARS~Co:v-2 Assiiy bil effective July 1s_,
2021, notins th!l.t it will no longer be in use as of July 15, 2021.
The authorization of a device for e:metgency use under section 564 ofihe Federal Food, Drug,
artd Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuarttto $ection. 564(g)~) of the Act,
be revoked when circumst!l.llces make such revocati011 appropriate to protect the pµ_blic health or
safely (section 564(g)(2)(C) of theAcQ. Because Curative has notified FDA that it will no longer
.be using the Curative SARS..:Cov _;2 Assay as ofJuly 15, 2021. and requests FDA revoke the
authorization effective that da:y, FDA has deterllifued that it is: appropriate to protect the public
healih or safecy to revoke Uris authoriza:fion. Accordingly, FDAherebyrevokes: EU:A.200132 for
the Curative SARS-Cov-2 Assay, pursuant to section 564(g)(2)(C) ofthe Act, As e>fthe date of
this letter, the Curative SARS_;Cov-2 A:ssiiy is no lon~er authorized for emergency use by FDA.
Notice of this rev◊cation wm be published in the Fedc.ralRMistift, pursuant. to section 564(h)(l)
oftheAct.
Sincerely,
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. (,f_\fcl••Q~µi}~M, Hint.on ·S
Hi nto n'L§:;:;;~•t~t;X.6~.5
RADM Denise M. Hinton
ChiefScientist
Foctd and Drug Administration
1 htrps)/www,prrtewswire.com/ne\VS"teletises/cura:tivecexpantls~testirig"OPtibilSctbr-covid"l9cffoctind:.:rsv-across-,
nationwide-healthcare-delivery-network-30.1314095:.htnil
Dated: August 26, 2021. DEPARTMENT OF HEALTH AND Services (60 FR 56605, as amended
Lauren K. Roth, HUMAN SERVICES November 6, 1995; as last amended at
Acting Principal Associate Commissioner for 86 FR 6344–6349 dated January 21,
Policy. Health Resources and Services 2021) is amended to reorganize sections
[FR Doc. 2021–18789 Filed 8–30–21; 8:45 am] Administration of the Office of the Administrator, the
Healthcare Systems Bureau, and the
BILLING CODE 4164–01–C
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Statement of Organization, Functions, Bureau of Primary Health Care.
and Delegations of Authority Key functional changes include re-
establishing, retaining and renaming the
Part R (Health Resources and Services Healthcare Systems Bureau to the
Administration) of the Statement of Health Systems Bureau; changing the
Organization, Functions and name of the Office of Provider Support
Delegations of Authority of the to the Provider Relief Bureau; changing
EN31AU21.042</GPH>
Department of Health and Human the name of the Office of Regional
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