Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability, 68177-68178 [2024-18973]
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Federal Register / Vol. 89, No. 164 / Friday, August 23, 2024 / Notices
The main benefits that Intarcia
highlights relate to its position that
ITCA 650 is a valuable new dosing
option because it may increase
medication adherence. Intarcia has not
provided data in support of its argument
but instead bases this assertion on the
fact that ITCA–650 is an implantable
device that lasts for 3 or 6 months.
However, the evidence offered in
support of approval undermines
Intarcia’s position. As previously
discussed, ITCA 650 has dose reliability
and variability issues. As previously
outlined in the EMDAC discussion
summary, multiple EMDAC members
expressed concern that the drug
delivery variability issue could lead to
patients receiving less reliable drug
doses than if they were using an
analogous drug regimen that was not
delivered via an implanted osmotic
pump. Therefore, if ITCA 650 does not
provide the proper dose, a patient
would become nonadherent to their
medication, regardless of the patient’s
intentions. The PDC therefore disagrees
with Intarcia and its experts that the
mode of drug delivery inherently
equates to medication adherence.
Furthermore, as found by CDER in its
proposed order, ‘‘Intarcia has provided
no evidence that demonstrates patients
prescribed ITCA 650 are more likely to
continue the treatment than patients
prescribed other approved treatments
for type 2 diabetes.’’ Given the lack of
concrete information to support its
theoretical argument, the PDC gives
little weight to this benefit in the overall
assessment of whether the benefit-risk
assessment supports approval of ITCA
650 in its present form.
khammond on DSKJM1Z7X2PROD with NOTICES
D. Conclusion
While Intarcia correctly points out in
its appeal that more therapies are
needed for patients with T2DM, FDA
will only approve NDAs when the data
shows that the benefits outweigh the
risks. After reviewing the information
contained in the public record, the PDC
finds that the benefits of ITCA 650 do
not outweigh its risks. The PDC agrees
with the EMDAC’s conclusions and find
that there are too many unanswered
questions regarding risks associated
with ITCA 650 to find that it has a
positive benefit-risk profile and is safe
under section 505(d)(2) of the FD&C
Act. For the reasons described above,
Intarcia has not presented adequate
evidence to show that the drug is safe
for use under the proposed conditions;
therefore, the PDC cannot approve the
NDA for ITCA 650.
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IV. Findings and Order
For the reasons described above, FDA
finds that the record shows that the
approval criteria set forth in section
505(d)(2) of the FD&C Act have not been
met, as ITCA 650’s risks outweigh its
benefits; therefore, Intarcia has not
demonstrated that ITCA 650 is safe for
its intended use. Therefore, under
section 505(d) of the FD&C Act, FDA
hereby denies approval to Intarcia’s
NDA in its current form.
Dated: August 16, 2024.
Namandjé N. Bumpus,
Principal Deputy Commissioner.
[FR Doc. 2024–18898 Filed 8–22–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1584]
Authorization of Emergency Use of
Certain Medical Devices During
COVID–19; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the issuance of Emergency
Use Authorizations (EUAs) (the
Authorizations) for certain medical
devices related to Coronavirus Disease
2019 (COVID–19). FDA has issued the
Authorizations listed in this document
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act). These
Authorizations contain, among other
things, conditions on the emergency use
of the authorized products. The
Authorization follows the February 4,
2020, determination by the Secretary of
Health and Human Services (HHS), as
amended on March 15, 2023, that there
is a public health emergency, or a
significant potential for a public health
emergency, that affects, or has a
significant potential to affect, national
security or the health and security of
U.S. citizens living abroad and that
involves the virus that causes COVID–
19, and the subsequent declarations on
February 4, 2020, March 2, 2020, and
March 24, 2020, that circumstances
exist justifying the authorization of
emergency use of in vitro diagnostics for
detection and/or diagnosis of the virus
that causes COVID–19, personal
respiratory protective devices, and
medical devices, including alternative
products used as medical devices,
respectively, subject to the terms of any
SUMMARY:
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68177
authorization issued under the FD&C
Act. These Authorizations, which
include an explanation of the reasons
for issuance, are listed in this document,
and can be accessed on FDA’s website
from the links indicated.
DATES: These Authorizations are
effective on their date of issuance.
ADDRESSES: Submit written requests for
single copies of an EUA 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 selfaddressed adhesive label to assist that
office in processing your request or
include a fax number to which the
Authorization may be sent. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the Authorization.
FOR FURTHER INFORMATION CONTACT: Kim
Sapsford-Medintz, 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, 301–
796–0311 (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,
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.
With this EUA authority, FDA can help
ensure that medical countermeasures
may be used in emergencies to diagnose,
treat, or prevent serious or lifethreatening diseases or conditions
caused by a biological, chemical,
radiological, or nuclear agent or agents
when there are no adequate, approved,
and available alternatives.
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (1) a
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a biological, chemical, radiological,
or nuclear agent or agents; (2) a
determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
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68178
Federal Register / Vol. 89, No. 164 / Friday, August 23, 2024 / Notices
a military emergency, involving a
heightened risk to U.S. military forces,
including personnel operating under the
authority of title 10 or title 50 of the
U.S. Code, of attack with (A) a
biological, chemical, radiological, or
nuclear agent or agents; or (B) an agent
or agents that may cause, or are
otherwise associated with, an
imminently life-threatening and specific
risk to U.S. military forces; 1 (3) a
determination by the Secretary of HHS
that there is a public health emergency,
or a significant potential for a public
health emergency, that affects, or has a
significant potential to affect, national
security or the health and security of
U.S. citizens living abroad, and that
involves a biological, chemical,
radiological, or nuclear agent or agents,
or a disease or condition that may be
attributable to such agent or agents; or
(4) the identification of a material threat
by the Secretary of Homeland Security
pursuant to section 319F–2 of the Public
Health Service (PHS) Act (42 U.S.C.
247d–6b) sufficient to affect national
security or the health and security of
U.S. citizens living abroad.
Once the Secretary of HHS has
declared that circumstances exist
justifying an authorization under
section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug,
device, or biological product if the
Agency concludes that the statutory
criteria are satisfied. Under section
564(h)(1) of the FD&C Act, FDA is
required to publish in the Federal
Register a notice of each authorization,
and each termination or revocation of an
authorization, and an explanation of the
reasons for the action. Under section
564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available
on the internet website of FDA. Section
564 of the FD&C Act permits FDA to
authorize the introduction into
interstate commerce of a drug, device, or
biological product intended for use
when the Secretary of HHS has declared
that circumstances exist justifying the
authorization of emergency use.
Products appropriate for emergency use
may include products and uses that are
not approved, cleared, or licensed under
section 505, 510(k), 512, or 515 of the
FD&C Act (21 U.S.C. 355, 360(k), 360b,
or 360e) or section 351 of the PHS Act
(42 U.S.C. 262), or conditionally
approved under section 571 of the FD&C
Act (21 U.S.C. 360ccc). FDA may issue
an EUA only if, after consultation with
1 In the case of a determination by the Secretary
of Defense, the Secretary of HHS shall determine
within 45 calendar days of such determination,
whether to make a declaration under section
564(b)(1) of the FD&C Act, and, if appropriate, shall
promptly make such a declaration.
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17:23 Aug 22, 2024
Jkt 262001
the HHS Assistant Secretary for
Preparedness and Response, the
Director of the National Institutes of
Health, and the Director of the Centers
for Disease Control and Prevention (to
the extent feasible and appropriate
given the applicable circumstances),
FDA 2 concludes: (1) that an agent
referred to in a declaration of emergency
or threat can cause a serious or lifethreatening disease or condition; (2)
that, based on the totality of scientific
evidence available to FDA, including
data from adequate and well-controlled
clinical trials, if available, it is
reasonable to believe that (A) the
product may be effective in diagnosing,
treating, or preventing (i) such disease
or condition; or (ii) a serious or lifethreatening disease or condition caused
by a product authorized under section
564, approved or cleared under the
FD&C Act, or licensed under section 351
of the PHS Act, for diagnosing, treating,
or preventing such a disease or
condition caused by such an agent; and
(B) the known and potential benefits of
the product, when used to diagnose,
prevent, or treat such disease or
condition, outweigh the known and
potential risks of the product, taking
into consideration the material threat
posed by the agent or agents identified
in a declaration under section
564(b)(1)(D) of the FD&C Act, if
applicable; (3) that there is no adequate,
approved, and available alternative to
the product for diagnosing, preventing,
or treating such disease or condition; (4)
in the case of a determination described
in section 564(b)(1)(B)(ii), that the
request for emergency use is made by
the Secretary of Defense; and (5) that
such other criteria as may be prescribed
by regulation are satisfied. No other
criteria for issuance have been
prescribed by regulation under section
564(c)(4) of the FD&C Act.
II. Electronic Access
An electronic version of this
document and the full text of the
Authorizations are available on the
internet and can be accessed from
https://www.fda.gov/emergencypreparedness-and-response/mcm-legalregulatory-and-policy-framework/
emergency-use-authorization.
III. The Authorizations
Having concluded that the criteria for
the issuance of the following
Authorizations under section 564(c) of
the FD&C Act are met, FDA has
authorized the emergency use of the
2 The Secretary of HHS has delegated the
authority to issue an EUA under section 564 of the
FD&C Act to the Commissioner of Food and Drugs.
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following products for diagnosing,
treating, or preventing COVID–19
subject to the terms of each
Authorization. The Authorizations in
their entirety, including any authorized
fact sheets and other written materials,
can be accessed from FDA’s web page
entitled ‘‘Emergency Use
Authorization,’’ available at https://
www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization. The lists that follow
include Authorizations issued from July
8, 2024, through July 23, 2024, and we
have included explanations of the
reasons for their issuance, as required
by section 564(h)(1) of the FD&C Act. In
addition, the EUAs that have been
reissued can be accessed from FDA’s
web page: https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/emergency-useauthorization.
FDA is hereby announcing the
following Authorizations for
multianalyte tests:
• Nano-Ditech Corporation’s NanoCheck Influenza+COVID–19 Dual Test,
issued on July 08, 2024.3
• ACON Laboratories, Inc.’s Flowflex
Plus COVID–19 and Flu A/B Home Test,
issued on July 23, 2024.4
Dated: August 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–18973 Filed 8–22–24; 8:45 am]
BILLING CODE 4164–01–P
3 As set forth in the EUA for this product, FDA
has concluded that: (1) SARS–CoV–2 can cause a
serious or life-threatening disease or condition,
including severe respiratory illness, to humans
infected by this virus; (2) based on the totality of
scientific evidence available to FDA, it is reasonable
to believe that the product may be effective in
diagnosing COVID–19 through the simultaneous
detection and differentiation of SARS–CoV–2,
influenza A virus, and/or influenza B virus protein
antigens, and that the known and potential benefits
of the product when used for diagnosing COVID–
19, outweigh the known and potential risks of such
product; and (3) there is no adequate, approved,
and available alternative to the emergency use of
the product.
4 As set forth in the EUA for this product, FDA
has concluded that: (1) SARS–CoV–2 can cause a
serious or life-threatening disease or condition,
including severe respiratory illness, to humans
infected by this virus; (2) based on the totality of
scientific evidence available to FDA, it is reasonable
to believe that the product may be effective in
diagnosing COVID–19 through the simultaneous
detection and differentiation of SARS–CoV–2,
influenza A virus and/or influenza B virus protein
antigens, and that the known and potential benefits
of the product when used for diagnosing COVID–
19, outweigh the known and potential risks of such
product; and (3) there is no adequate, approved,
and available alternative to the emergency use of
the product.
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]]>Agencies
[Federal Register Volume 89, Number 164 (Friday, August 23, 2024)]
[Notices]
[Pages 68177-68178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18973]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1584]
Authorization of Emergency Use of Certain Medical Devices During
COVID-19; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the issuance of Emergency Use Authorizations (EUAs) (the
Authorizations) for certain medical devices related to Coronavirus
Disease 2019 (COVID-19). FDA has issued the Authorizations listed in
this document under the Federal Food, Drug, and Cosmetic Act (FD&C
Act). These Authorizations contain, among other things, conditions on
the emergency use of the authorized products. The Authorization follows
the February 4, 2020, determination by the Secretary of Health and
Human Services (HHS), as amended on March 15, 2023, that there is a
public health emergency, or a significant potential for a public health
emergency, that affects, or has a significant potential to affect,
national security or the health and security of U.S. citizens living
abroad and that involves the virus that causes COVID-19, and the
subsequent declarations on February 4, 2020, March 2, 2020, and March
24, 2020, that circumstances exist justifying the authorization of
emergency use of in vitro diagnostics for detection and/or diagnosis of
the virus that causes COVID-19, personal respiratory protective
devices, and medical devices, including alternative products used as
medical devices, respectively, subject to the terms of any
authorization issued under the FD&C Act. These Authorizations, which
include an explanation of the reasons for issuance, are listed in this
document, and can be accessed on FDA's website from the links
indicated.
DATES: These Authorizations are effective on their date of issuance.
ADDRESSES: Submit written requests for single copies of an EUA 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 Authorization may be sent. See the SUPPLEMENTARY
INFORMATION section for electronic access to the Authorization.
FOR FURTHER INFORMATION CONTACT: Kim Sapsford-Medintz, 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, 301-796-0311 (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,
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. With this EUA authority, FDA can help ensure that
medical countermeasures may be used in emergencies to diagnose, treat,
or prevent serious or life-threatening diseases or conditions caused by
a biological, chemical, radiological, or nuclear agent or agents when
there are no adequate, approved, and available alternatives.
Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
a determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for
[[Page 68178]]
a military emergency, involving a heightened risk to U.S. military
forces, including personnel operating under the authority of title 10
or title 50 of the U.S. Code, of attack with (A) a biological,
chemical, radiological, or nuclear agent or agents; or (B) an agent or
agents that may cause, or are otherwise associated with, an imminently
life-threatening and specific risk to U.S. military forces; \1\ (3) a
determination by the Secretary of HHS that there is a public health
emergency, or a significant potential for a public health emergency,
that affects, or has a significant potential to affect, national
security or the health and security of U.S. citizens living abroad, and
that involves a biological, chemical, radiological, or nuclear agent or
agents, or a disease or condition that may be attributable to such
agent or agents; or (4) the identification of a material threat by the
Secretary of Homeland Security pursuant to section 319F-2 of the Public
Health Service (PHS) Act (42 U.S.C. 247d-6b) sufficient to affect
national security or the health and security of U.S. citizens living
abroad.
---------------------------------------------------------------------------
\1\ In the case of a determination by the Secretary of Defense,
the Secretary of HHS shall determine within 45 calendar days of such
determination, whether to make a declaration under section 564(b)(1)
of the FD&C Act, and, if appropriate, shall promptly make such a
declaration.
---------------------------------------------------------------------------
Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Under section 564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available on the internet website of
FDA. Section 564 of the FD&C Act permits FDA to authorize the
introduction into interstate commerce of a drug, device, or biological
product intended for use when the Secretary of HHS has declared that
circumstances exist justifying the authorization of emergency use.
Products appropriate for emergency use may include products and uses
that are not approved, cleared, or licensed under section 505, 510(k),
512, or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 360b, or 360e) or
section 351 of the PHS Act (42 U.S.C. 262), or conditionally approved
under section 571 of the FD&C Act (21 U.S.C. 360ccc). FDA may issue an
EUA only if, after consultation with the HHS Assistant Secretary for
Preparedness and Response, the Director of the National Institutes of
Health, and the Director of the Centers for Disease Control and
Prevention (to the extent feasible and appropriate given the applicable
circumstances), FDA \2\ concludes: (1) that an agent referred to in a
declaration of emergency or threat can cause a serious or life-
threatening disease or condition; (2) that, based on the totality of
scientific evidence available to FDA, including data from adequate and
well-controlled clinical trials, if available, it is reasonable to
believe that (A) the product may be effective in diagnosing, treating,
or preventing (i) such disease or condition; or (ii) a serious or life-
threatening disease or condition caused by a product authorized under
section 564, approved or cleared under the FD&C Act, or licensed under
section 351 of the PHS Act, for diagnosing, treating, or preventing
such a disease or condition caused by such an agent; and (B) the known
and potential benefits of the product, when used to diagnose, prevent,
or treat such disease or condition, outweigh the known and potential
risks of the product, taking into consideration the material threat
posed by the agent or agents identified in a declaration under section
564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no
adequate, approved, and available alternative to the product for
diagnosing, preventing, or treating such disease or condition; (4) in
the case of a determination described in section 564(b)(1)(B)(ii), that
the request for emergency use is made by the Secretary of Defense; and
(5) that such other criteria as may be prescribed by regulation are
satisfied. No other criteria for issuance have been prescribed by
regulation under section 564(c)(4) of the FD&C Act.
---------------------------------------------------------------------------
\2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------
II. Electronic Access
An electronic version of this document and the full text of the
Authorizations are available on the internet and can be accessed from
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
III. The Authorizations
Having concluded that the criteria for the issuance of the
following Authorizations under section 564(c) of the FD&C Act are met,
FDA has authorized the emergency use of the following products for
diagnosing, treating, or preventing COVID-19 subject to the terms of
each Authorization. The Authorizations in their entirety, including any
authorized fact sheets and other written materials, can be accessed
from FDA's web page entitled ``Emergency Use Authorization,'' available
at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. The lists
that follow include Authorizations issued from July 8, 2024, through
July 23, 2024, and we have included explanations of the reasons for
their issuance, as required by section 564(h)(1) of the FD&C Act. In
addition, the EUAs that have been reissued can be accessed from FDA's
web page: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
FDA is hereby announcing the following Authorizations for
multianalyte tests:
Nano-Ditech Corporation's Nano-Check Influenza+COVID-19
Dual Test, issued on July 08, 2024.\3\
---------------------------------------------------------------------------
\3\ As set forth in the EUA for this product, FDA has concluded
that: (1) SARS-CoV-2 can cause a serious or life-threatening disease
or condition, including severe respiratory illness, to humans
infected by this virus; (2) based on the totality of scientific
evidence available to FDA, it is reasonable to believe that the
product may be effective in diagnosing COVID-19 through the
simultaneous detection and differentiation of SARS-CoV-2, influenza
A virus, and/or influenza B virus protein antigens, and that the
known and potential benefits of the product when used for diagnosing
COVID-19, outweigh the known and potential risks of such product;
and (3) there is no adequate, approved, and available alternative to
the emergency use of the product.
---------------------------------------------------------------------------
ACON Laboratories, Inc.'s Flowflex Plus COVID-19 and Flu
A/B Home Test, issued on July 23, 2024.\4\
---------------------------------------------------------------------------
\4\ As set forth in the EUA for this product, FDA has concluded
that: (1) SARS-CoV-2 can cause a serious or life-threatening disease
or condition, including severe respiratory illness, to humans
infected by this virus; (2) based on the totality of scientific
evidence available to FDA, it is reasonable to believe that the
product may be effective in diagnosing COVID-19 through the
simultaneous detection and differentiation of SARS-CoV-2, influenza
A virus and/or influenza B virus protein antigens, and that the
known and potential benefits of the product when used for diagnosing
COVID-19, outweigh the known and potential risks of such product;
and (3) there is no adequate, approved, and available alternative to
the emergency use of the product.
Dated: August 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-18973 Filed 8-22-24; 8:45 am]
BILLING CODE 4164-01-P
