Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability, 53064-53067 [2021-20754]

Download as PDF 53064 Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices website at the time of the advisory committee meeting. Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before November 23, 2021, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 2:30 p.m. and 3:30 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 15, 2021. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 16, 2021. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Joyce Yu (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). VerDate Sep<11>2014 16:50 Sep 23, 2021 Jkt 253001 Dated: September 17, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993–0002, 240–402–8155 (this is not a toll-free number). [FR Doc. 2021–20733 Filed 9–23–21; 8:45 am] SUPPLEMENTARY INFORMATION: BILLING CODE 4164–01–P I. Background DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0973] Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID–19; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Gravity Diagnostics, LLC (Gravity) for the Gravity Diagnostics COVID–19 Assay, Materials and Machines Corporation of America (DBA MatmaCorp, Inc.) (Matmacorp) for the MatMaCorp COVID–19 2SF Test, and Guardant Health Inc. (Guardant) for the Guardant19. FDA revoked Gravity’s Authorization on July 21, 2021, Matmacorp’s Authorization on August 3, 2021, and Guardant’s Authorization on August 6, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document. SUMMARY: Gravity’s Authorization is revoked as of July 21, 2021. Matmacorp’s Authorization is revoked as of August 3, 2021. Guardant’s Authorization is revoked as of August 6, 2021. ADDRESSES: Submit written requests for single copies of the revocations to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request or include a Fax number to which the revocations may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the revocations. FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 DATES: PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological 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 June 1, 2020, FDA issued an EUA to Gravity for the Gravity Diagnostics COVID–19 Assay. Notice of the issuance of this Authorization was published in the Federal Register on November 20, 2020 (85 FR 74346), as required by section 564(h)(1) of the FD&C Act. On August 21, 2020, FDA issued an EUA to Guardant for the Guardant-19. Notice of the issuance of this Authorization was published in the Federal Register on November 20, 2020 (85 FR 74346), as required by section 564(h)(1) of the FD&C Act. On December 17, 2020, FDA issued an EUA to Matmacorp, for the MatMaCorp COVID–19 2SF Test. Notice of the issuance of this Authorization was published in the Federal Register on April 23, 2021 (86 FR 21749), as required by section 564(h)(1) of the FD&C Act. 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. EUA Revocation Requests On March 11, 2021, and reconfirmed July 12, 2021, Gravity requested the revocation of, and on July 21, 2021, FDA revoked, the Authorization for the Gravity Diagnostics COVID–19 Assay. Because Gravity notified FDA that it is no longer using the Gravity Diagnostics COVID–19 Assay and requested FDA revoke the Authorization, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. On July 29, 2021, Matmacorp requested the revocation of, and on August 3, 2021, FDA revoked, the Authorization for the MatMaCorp COVID–19 2SF Test. Because Matmacorp notified FDA that it E:\FR\FM\24SEN1.SGM 24SEN1 Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices will no longer be distributing the MatMaCorp COVID–19 2SF Test as of July 31, 2021, and requested FDA revoke the Authorization effective that day, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. On August 2, 2021, Guardant requested the revocation of, and on August 6, 2021, FDA revoked, the Authorization for the Guardant-19. Because Guardant requested that FDA revoke the Authorization, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. IV. The Revocations III. Electronic Access An electronic version of this document and the full text of the revocations are available on the internet at https://www.regulations.gov/, https:// www.fda.gov/media/151030/download, https://www.fda.gov/media/151349/ download, and https://www.fda.gov/ media/151378/download. :1ames:1tC:a.nnei :Pti.tx .. 53065 Having concluded that the criteria for revocation of the Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA has revoked the EUAs for Gravity’s Gravity Diagnostics COVID–19 Assay, Matmacorp’s MatMaCorp COVID–19 2SF Test, and Guardant’s Guardant-19. The revocations in their entirety follow and provide an explanation of the reasons for each revocation, as required by section 564(h)(1) of the FD&C Act. BILLING CODE 4164–01–P .. .. . .. .. ~~7~~ l)"~l)t\~~t: =~=:=;~===.tty ai:L~~¥~~ ===a~=:~=4~ Diagnostics COV:ID-19 Assay issued on June l; 2020; and amended,onJune:30;'2020~ and. September 21, 2()20; Gravity c<>nf"ttmedthatitis no1ongetusingthe Qtavity Diagnostics . ¢PW· t~ ~s~'~GPJviiy;s:,h\borati)J:y,.ba:~J~iticmt:id·tQ a:tt'Qffiet~trA.~autJt~~test, defeiminedthat'it•is . apptopriateto prriteI:tthepublre'heilfih-0rsafetytorevoke·thm·•authoriza:tion. Notice.of this revocation will be published in the Federal Register, pursuant to section 564(li)(J) oftheAct. Sincerely, Isl VerDate Sep<11>2014 16:50 Sep 23, 2021 Jkt 253001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE21.000</GPH> RADM Denise M. Hinton Chief Scientist Food and Drug Administration 53066 Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices August 3, 2021 Dustin Petrik, Ph:. 0. ~~~zyliaison . Materials and Machines Corporation of America (OBA MatmaCm:p, Inc.) 6400Comhusker Hwy. Suite 300 Lmcoln, NB 68507 . Re: KevncationofEUAlD2648. Dear Dr. Petrik, This letter isin response.to.MatmaCorp,Jnc. 's (Matniacorp)iequestdatedJnly 29, 2021, thatthe U.S. Food and Drug Administration (FDA) revoke the EmergencyUse Autborization(BUA202648)forthe MatMaCorp COVID-192SFTest issued on December 17, 2020. ln its July 29 Ietter,Ma1macorp requested revocation of the MatMaCotp COVID-19 2SFTesteffec1ive1nly 31, 2021. The au1horization ofa device for emergency use under section564 of the F.ederal Food, Drug. and Cosmetic Act(theAct)(21 U.S.C. 360bbb~3)may, pursuant to section 564(g)(2)ofthe Act; be revoked when cireumstanc.es makesuch revocation appropriate to protect the public health or safety (section 564(g)(2)(C) of the Act). Because Matmac-01:p h~ notified FDA thatit will no longer be distributing1he MatMaCorp COVID-19 2SF Test as of July 31, 2021~ and requ~ FDA revoke the authorization effective that day, FDA has detennined that it is appropriate to proteci the public health or safety to revoke this authorization. Accordingly, FDA hereby revokes EUA202648 for MatMaCorpCOVID-19 2SF Test;. pursuantto section 564(g)(2)(C) of the Act As of the date of this letter, the MatMaCoi:p COVID-19 2SF Test is no longer authorized for emergency use by FDA. · · Notic.e of this revocation will be published in theFederalRegister, pursuantto section 564(hXI)ofthe Act Sincerely, Isl VerDate Sep<11>2014 16:50 Sep 23, 2021 Jkt 253001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4725 E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE21.001</GPH> RADMDenise M. Hinton Chief Scientist Food and Drug Administration Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Notices 53067 br.~tie•.·~s- St',.llirtel:Ol'; R~li®ij A~rs· Gu~tliealthrlnC; S.0$:Penobs(lotlmve rumw~Cityf CAM06l B.e;•·a~\iij•do11ijfEVAlol347 Deal' bi Bess~; Thi$letterisciii~#$ehl~Realthtnc!s (®ar~)Jeqttest.da~d~µgusi;2021,~atthe u.s. •itQQd~d·UruJM~tiott(FO~l'J\'oke1heEn1e~··u11,.At1tnimz1ti9ll.(£UA2Q1347Jior Guatdant~l9issuedonA~st21>2020.lUld~'1edort.~28i202(L· IniisA1JSU!lt 2 letter. Guardtnt~qu~tev®a1ion of».'te Ciuardaut..JSl:etfec.ti,•tJuty l tt2()2i, 'Iltti autlio:ri~~on-0fadeti~fot eroe~llSeunderseciions6' otthe Fe~e~t FijOi\ tints. arid. .· • CO$medeAct(th~A-0t)(21 U,S.C,l6~bt,l)..3lm~;J)Ul'$U$lt\o~On5ti4@(2.)<>fthe~berevoltj,d •~encircumstanW$malu,~sucn·tey($11ionappropriatetoptOtet:tfliepublichealthOtSife(J(Secti~n 564(g)(2)(C)oftt1~Act)~. Bec,use Guardam hasrequestedtbiltFDAtevoketheauthori7.ation. a)A has detwmined1hatit~apJ)topdate:fo1Wteetlhepubliehe!llftl .9-tsaf«,torevoktl.tfds~oo1.at1on. A¢eordingly;ffiAhen.,by~•oke$Bt1A2~l~!~G~~H9, Jtl#SQ!mt1<>*1ion$6t{g) . ofthe Act A$ otthedateoft1tisletter,ftle(mardanH9isnolongerauthorlzed.foremei:geneyuse A Noiite of tliisiev~n'\\citl1>¢publisfuldfuthe.Fe:d¢ra/Regtstet, puisuantfu ~ectfon 564(hj(1)-0f'ibeAc:t Isl &AD~ DenfselVL·8iJ3ton 0 ·Chi,£ Scientist FQodartdOrug.Adrtim1~00 DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2021–20754 Filed 9–23–21; 8:45 am] [Docket No. FDA–2021–N–0897] BILLING CODE 4164–01–C Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice; establishment of a public docket; request for comments. ACTION: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs SUMMARY: VerDate Sep<11>2014 16:50 Sep 23, 2021 Jkt 253001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. The meeting will be held on December 2, 2021, from 9 a.m. to 5 p.m. Eastern Time. ADDRESSES: Please note that due to the impact of this COVID–19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Answers to commonly asked questions about FDA advisory committee meetings may be accessed at: https:// DATES: E:\FR\FM\24SEN1.SGM 24SEN1 EN24SE21.002</GPH> Dated: September 17, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy.

Agencies

[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Pages 53064-53067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20754]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0973]


Revocation of Three Authorizations of Emergency Use of In Vitro 
Diagnostic Devices for Detection and/or Diagnosis of COVID-19; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of the Emergency Use Authorizations (EUAs) (the 
Authorizations) issued to Gravity Diagnostics, LLC (Gravity) for the 
Gravity Diagnostics COVID-19 Assay, Materials and Machines Corporation 
of America (DBA MatmaCorp, Inc.) (Matmacorp) for the MatMaCorp COVID-19 
2SF Test, and Guardant Health Inc. (Guardant) for the Guardant-19. FDA 
revoked Gravity's Authorization on July 21, 2021, Matmacorp's 
Authorization on August 3, 2021, and Guardant's Authorization on August 
6, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The 
revocations, which include an explanation of the reasons for each 
revocation, are reprinted in this document.

DATES: Gravity's Authorization is revoked as of July 21, 2021. 
Matmacorp's Authorization is revoked as of August 3, 2021. Guardant's 
Authorization is revoked as of August 6, 2021.

ADDRESSES: Submit written requests for single copies of the revocations 
to the Office of Counterterrorism and Emerging Threats, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, 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 revocations may be sent. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the revocations.

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002, 240-402-8155 (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to 
strengthen the public health protections against biological, chemical, 
nuclear, and radiological 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 June 1, 2020, FDA issued an EUA to Gravity for the 
Gravity Diagnostics COVID-19 Assay. Notice of the issuance of this 
Authorization was published in the Federal Register on November 20, 
2020 (85 FR 74346), as required by section 564(h)(1) of the FD&C Act. 
On August 21, 2020, FDA issued an EUA to Guardant for the Guardant-19. 
Notice of the issuance of this Authorization was published in the 
Federal Register on November 20, 2020 (85 FR 74346), as required by 
section 564(h)(1) of the FD&C Act. On December 17, 2020, FDA issued an 
EUA to Matmacorp, for the MatMaCorp COVID-19 2SF Test. Notice of the 
issuance of this Authorization was published in the Federal Register on 
April 23, 2021 (86 FR 21749), as required by section 564(h)(1) of the 
FD&C Act. 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. EUA Revocation Requests

    On March 11, 2021, and reconfirmed July 12, 2021, Gravity requested 
the revocation of, and on July 21, 2021, FDA revoked, the Authorization 
for the Gravity Diagnostics COVID-19 Assay. Because Gravity notified 
FDA that it is no longer using the Gravity Diagnostics COVID-19 Assay 
and requested FDA revoke the Authorization, FDA has determined that it 
is appropriate to protect the public health or safety to revoke this 
Authorization. On July 29, 2021, Matmacorp requested the revocation of, 
and on August 3, 2021, FDA revoked, the Authorization for the MatMaCorp 
COVID-19 2SF Test. Because Matmacorp notified FDA that it

[[Page 53065]]

will no longer be distributing the MatMaCorp COVID-19 2SF Test as of 
July 31, 2021, and requested FDA revoke the Authorization effective 
that day, FDA has determined that it is appropriate to protect the 
public health or safety to revoke this Authorization. On August 2, 
2021, Guardant requested the revocation of, and on August 6, 2021, FDA 
revoked, the Authorization for the Guardant-19. Because Guardant 
requested that FDA revoke the Authorization, 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 
revocations are available on the internet at https://www.regulations.gov/, https://www.fda.gov/media/151030/download, 
https://www.fda.gov/media/151349/download, and https://www.fda.gov/media/151378/download.

IV. The Revocations

    Having concluded that the criteria for revocation of the 
Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA 
has revoked the EUAs for Gravity's Gravity Diagnostics COVID-19 Assay, 
Matmacorp's MatMaCorp COVID-19 2SF Test, and Guardant's Guardant-19. 
The revocations in their entirety follow and provide an explanation of 
the reasons for each revocation, as required by section 564(h)(1) of 
the FD&C Act.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TN24SE21.000


[[Page 53066]]


[GRAPHIC] [TIFF OMITTED] TN24SE21.001


[[Page 53067]]


[GRAPHIC] [TIFF OMITTED] TN24SE21.002


    Dated: September 17, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-20754 Filed 9-23-21; 8:45 am]
BILLING CODE 4164-01-C