Rule2025-16034
Medical Devices; Immunology and Microbiology Devices; Classification of A Multiplex Respiratory Panel To Detect and Identify Emerging Respiratory Pathogen(s) and Common Respiratory Pathogens in Human Clinical Specimens
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
August 21, 2025
Effective
August 21, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is classifying the multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Full Text
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<title>Federal Register, Volume 90 Issue 160 (Thursday, August 21, 2025)</title>
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[Federal Register Volume 90, Number 160 (Thursday, August 21, 2025)]
[Rules and Regulations]
[Pages 40709-40713]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16034]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2025-N-2788]
Medical Devices; Immunology and Microbiology Devices;
Classification of A Multiplex Respiratory Panel To Detect and Identify
Emerging Respiratory Pathogen(s) and Common Respiratory Pathogens in
Human Clinical Specimens
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
classifying the multiplex respiratory panel to detect and identify
emerging respiratory pathogen(s) and common respiratory pathogens in
human clinical specimens into class II (special controls). The special
controls that apply to the device type are identified in this order and
will be part of the codified language for classification of the
multiplex respiratory panel to detect and identify emerging respiratory
pathogen(s) and common respiratory pathogens in human clinical
specimens. We are taking this action because we have determined that
classifying the device into class II will provide a reasonable
assurance of safety and effectiveness of the device. We believe this
action will also enhance patients' access to beneficial innovative
devices, in part by reducing regulatory burdens.
DATES: This order is effective August 21, 2025. The classification was
applicable on November 24, 2017.
FOR FURTHER INFORMATION CONTACT: Ryan Lubert, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3574, Silver Spring, MD 20993-0002, 240-402-6357,
<a href="/cdn-cgi/l/email-protection#1f4d667e7131536a7d7a6d6b5f797b7e3177776c31787069"><span class="__cf_email__" data-cfemail="693b10080747251c0b0c1b1d290f0d084701011a470e061f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the multiplex respiratory panel to
detect and identify emerging respiratory pathogen(s) and common
respiratory pathogens in human clinical specimens as class II (special
controls), which we have determined will provide a reasonable assurance
of safety and effectiveness. In addition, we believe this action will
enhance patients' access to beneficial innovation, in part by reducing
regulatory burdens by placing the device into a lower device class than
the automatic class III assignment.
The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate device by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)).
Section 207 of the Food and Drug Administration Modernization Act of
1997 (Pub. L. 105-115) established the first procedure for De Novo
classification. Section 607 of the Food and Drug Administration Safety
and Innovation Act (Pub. L. 112-144) modified the De Novo application
process by adding a second procedure. A device sponsor may utilize
either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
[[Page 40710]]
Under either procedure for De Novo classification, FDA shall
classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 513 (f)(2)(B)(i) of the FD&C
Act). As a result, other device sponsors do not have to submit a De
Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less burdensome 510(k) process, when necessary, to market their device.
II. De Novo Classification
On October 4, 2017, FDA received BioFire Diagnostics, LLC's request
for De Novo classification of the FilmArray Respiratory Panel 2 plus
(RP2plus). FDA reviewed the request in order to classify the device
under the criteria for classification set forth in section 513(a)(1) of
the FD&C Act.
We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see section 513(a)(1)(B) of the FD&C Act). After
review of the information submitted in the request, we determined that
the device can be classified into class II with the establishment of
special controls. FDA has determined that these special controls, in
addition to the general controls, will provide reasonable assurance of
the safety and effectiveness of the device.
Therefore, on November 24, 2017, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
866.4001.\1\ We have named the generic type of device ``a multiplex
respiratory panel to detect and identify emerging respiratory
pathogen(s) and common respiratory pathogens in human clinical
specimens,'' and it is identified as an in vitro diagnostic device
intended for the qualitative detection and identification of both
emerging and common respiratory pathogens from individuals meeting
specific emerging respiratory pathogen clinical and/or epidemiological
criteria. For example, clinical signs and symptoms associated with
infection of the emerging respiratory pathogen, contact with a probable
or confirmed emerging respiratory pathogen case, history of travel to
geographic locations where cases of the emerging respiratory pathogen
were detected, or other epidemiological links for which testing of the
emerging respiratory pathogen may be indicated. A device to detect and
identify emerging respiratory pathogen(s) and common respiratory
pathogens in human clinical specimens, and in turn to distinguish
emerging respiratory pathogen(s) from common respiratory pathogens, is
intended to aid in the differential diagnosis of the emerging
respiratory pathogen infection, in conjunction with other clinical,
epidemiologic, and laboratory data, in accordance with the guidelines
provided by the appropriate public health authorities.
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\1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
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FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.
Table 1--A Multiplex Respiratory Panel To Detect and Identify Emerging
Respiratory Pathogen(s) and Common Respiratory Pathogens in Human
Clinical Specimens Risks and Mitigation Measures
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Identified risks to health Mitigation measures
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Incorrect identification or lack of General controls and
identification of the emerging respiratory special controls (1), (2),
pathogen and other common respiratory (3), (4), (5), (6).
pathogens by the device can lead to
improper patient management and public
health response.
------------------------------------------------------------------------
FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this final order. This device is subject to premarket notification
requirements under section 510(k).
III. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in part 860, subpart D, regarding De Novo classification
have been approved under OMB control number 0910-0844; the collections
of information in 21 CFR part 814, subparts A through E, regarding
premarket approval have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions have been approved under OMB control
number 0910-0120; the collections of information in 21 CFR part 820
regarding quality system regulation have been approved under OMB
control number 0910-0073; and the collections of information in 21 CFR
parts 801 and 809 regarding labeling have been approved under OMB
control number 0910-0485.
[[Page 40711]]
List of Subjects in 21 CFR Part 866
Biologics, Laboratories, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
866 is amended as follows:
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES
0
1. The authority citation for part 866 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 866.4001 to subpart D to read as follows:
Sec. 866.4001 A multiplex respiratory panel to detect and identify
emerging respiratory pathogen(s) and common respiratory pathogens in
human clinical specimens.
(a) Identification. A multiplex respiratory panel to detect and
identify emerging respiratory pathogen(s) and common respiratory
pathogens in human clinical specimens is identified as an in vitro
diagnostic device intended for the qualitative detection and
identification of both emerging and common respiratory pathogens from
individuals meeting specific emerging respiratory pathogen clinical
and/or epidemiological criteria. For example, clinical signs and
symptoms associated with infection of the emerging respiratory
pathogen, contact with a probable or confirmed emerging respiratory
pathogen case, history of travel to geographic locations where cases of
the emerging respiratory pathogen were detected, or other
epidemiological links for which testing of the emerging respiratory
pathogen may be indicated. A device to detect and identify emerging
respiratory pathogen(s) and common respiratory pathogens in human
clinical specimens, and in turn to distinguish emerging respiratory
pathogen(s) from common respiratory pathogens, is intended to aid in
the differential diagnosis of the emerging respiratory pathogen
infection, in conjunction with other clinical, epidemiologic, and
laboratory data, in accordance with the guidelines provided by the
appropriate public health authorities.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) The intended use for the labeling required under Sec. 809.10
of this chapter must include a description of what the device detects
and measures, the specimen types, the results provided to the user, the
clinical indications for which the test is to be used, the specific
intended population(s), the testing location(s) where the device is to
be used (if applicable), and other conditions of use as appropriate.
(2) The labeling required under Sec. 809.10 of this chapter must
include:
(i) A device description, including the parts that make up the
device, ancillary reagents required but not provided, and an
explanation of the methodology.
(ii) Performance characteristics from analytical studies, including
cut-off (if applicable), analytical sensitivity (i.e., limit of
detection), inclusivity, reproducibility, interference, cross-
reactivity, instrument carryover/cross-contamination (if applicable),
and specimen stability.
(iii) Detailed instructions for minimizing the risk of potential
users' exposure to the emerging respiratory pathogen(s) that may be
present in test specimens and those used as control materials.
(iv) Detailed instructions for minimizing the risk of generating
false positive test results due to carry-over contamination from
positive test specimens and/or positive control materials.
(v) A warning statement that the interpretation of test results
requires experienced healthcare professionals who have training in
principles and use of infectious disease diagnostics and reporting of
results, in conjunction with the patient's medical history, clinical
signs and symptoms, and the results of other diagnostic tests.
(vi) A warning statement that culture should not be attempted in
cases of positive results for an emerging respiratory pathogen unless a
facility with an appropriate level of laboratory biosafety (e.g., BSL 3
and BSL 3+) is available to receive and culture specimens.
(vii) A warning statement that device positive results for one or
more common respiratory pathogens do not rule out bacterial infection,
or co-infection with other common respiratory pathogens.
(viii) A warning statement that respiratory pathogen(s) detected
may not be the definite cause of disease.
(ix) A warning statement that the use of additional laboratory
testing (e.g. bacterial culture, immunofluorescence, x-ray findings)
and clinical presentation must be taken into consideration in order to
obtain the final diagnosis of a respiratory infection.
(x) A limiting statement that device negative results for the
common respiratory pathogens do not preclude infection of a respiratory
pathogen and should not be used as the sole basis for diagnosis,
treatment, or other patient management decisions.
(xi) A limiting statement that analyte targets (e.g., pathogen
nucleic acid sequences or other molecular signatures) may persist in
vivo, independent of organism viability. Detection of analyte target(s)
does not imply that the corresponding pathogen(s) is infectious, nor is
the causative agent(s) for clinical symptoms.
(xii) A limiting statement that detection of pathogen nucleic acid
sequences or other molecular signatures is dependent upon proper
specimen collection, handling, transportation, storage and preparation.
Failure to observe proper procedures in any one of these steps can lead
to incorrect results. There is a risk of false negative values
resulting from improperly collected, transported, or handled specimens.
(xiii) A limiting statement that there is a risk of false positive
values resulting from cross-contamination by target organisms, their
nucleic acids or amplified product, or from non-specific signals in the
assay.
(xiv) A limiting statement that there is a risk of false negative
results due to the presence of nucleic acid sequence variants in the
pathogen targets of the device.
(xv) A limiting statement that device performance was not
established in immunocompromised patients.
(xvi) A limiting statement that positive and negative predictive
values are highly dependent on prevalence. The device performance was
established during one or more specific respiratory seasons. The
performance for some respiratory pathogens may vary depending on the
prevalence and patient population tested. False positive test results
are likely when prevalence of disease due to a particular respiratory
pathogen is low or non-existent in a community.
(xvii) In situations where the performance of the device was
estimated based largely on testing pre-selected banked retrospective
clinical specimens and/or contrived clinical specimen, a limiting
statement that the estimated device performance of that specific
pathogen or pathogen subtype may not reflect the performance or
prevalence in the intended use population.
(xviii) For devices with an intended use that includes detection of
emerging respiratory pathogen(s), a limiting statement that testing
with the device should not be performed unless the patient meets
clinical and/or epidemiologic criteria for testing suspected specimens
of the emerging respiratory pathogen.
[[Page 40712]]
(xix) For devices with an intended use that includes detection of
emerging respiratory pathogen(s), a limiting statement that positive
results obtained with the device for the emerging respiratory pathogen
are for the presumptive identification of that pathogen and that the
definitive identification of the emerging respiratory pathogen requires
additional testing and confirmation procedures in consultation with the
appropriate public health authorities (e.g., local or state public
health departments) for whom reporting is necessary.
(xx) For devices with an intended use that includes detection of
emerging respiratory pathogen(s), a limiting statement that negative
results for the emerging respiratory pathogen, even in the context of
device positive results for one or more of the common respiratory
pathogens, do not preclude infection with the emerging respiratory
pathogen and should not be used as the sole basis for patient
management decisions.
(xxi) For devices with an intended use that includes detection of
emerging respiratory pathogen(s), a limiting statement that negative
results for the emerging respiratory pathogen may be due to infection
of the emerging respiratory pathogen at a specific respiratory tract
location that may not be detected by a particular clinical specimen
type. A negative result for the emerging respiratory pathogen in an
asymptomatic individual does not rule out the possibility of future
illness and does not demonstrate that the individual is not infectious.
(xxii) For devices with an intended use that includes detection of
emerging respiratory pathogen(s), a limiting statement that a
nationally notifiable Rare Disease of Public Health Significance caused
by an emerging respiratory pathogen must be reported, as appropriate,
to public health authorities in accordance with local, state, and
federal law.
(3) Design verification and validation must include:
(i) Performance results of an appropriate clinical study (e.g., a
prospective clinical study) for each specimen type, and, if
appropriate, results from additional characterized samples. The
clinical study must be performed on a study population consistent with
the intended use population and must compare the device performance to
results obtained using FDA-accepted comparator methods or to expected
negative results if the infection is not generally expected in the
intended use population. Clinical specimens evaluated in the study must
contain relevant organism concentrations applicable to the specimen
type(s) and the targeted analyte(s). Detailed documentation must be
kept of that study and its results, including the study protocol, study
report for the proposed intended use, testing results, and results of
all statistical analyses.
(ii) For devices with an intended use that includes detection of
emerging respiratory pathogen(s) for which an FDA recommended panel is
available, design verification and validation must include the
performance results of an analytical study testing an FDA recommended
reference panel of characterized samples that contain the emerging
respiratory pathogen. Detailed documentation must be kept of that study
and its results, including the study protocol, study report for the
proposed intended use, testing results, and results of all statistical
analyses.
(iii) An appropriate risk mitigation strategy, including a detailed
description of all procedures and methods, for the post-market
identification of genetic mutations and/or novel respiratory pathogen
isolates or strains (e.g., regular review of published literature and
annual in silico analysis of target sequences to detect possible
mismatches. The required documentation for this device must also
include all of the results, including any findings, from the
application of this post-market mitigation strategy.
(iv) For devices with an intended use that includes detection of
multiple common respiratory pathogens, in addition to detecting
emerging respiratory pathogen(s) in human clinical specimens, a
detailed description of the identity, phylogenetic relationship, or
other recognized characterization of the common respiratory pathogens
that the device is designed to detect is addressed. Also, address in
detail how the device results might be used in a diagnostic algorithm
and other measures that might be needed for a laboratory diagnosis of
respiratory tract infection. Perform an evaluation of the device
compared to a currently appropriate and FDA accepted comparator method.
Detailed documentation must be kept of that study and its results,
including the study protocol, study report for the proposed intended
use, testing results, and results of all statistical analyses.
(v) A detailed device description, including the parts that make up
the device, ancillary reagents required but not provided, and a
detailed explanation of the methodology, including molecular target(s)
for each analyte, design of target detection reagents, rationale for
target selection, limiting factors of the device (e.g., saturation
level of hybridization and maximum amplification and detection cycle
number), internal and external controls, and computational path from
collected raw data to reported result (e.g., how collected raw signals
are converted into a reported signal and result), as applicable and
appropriate.
(vi) A detailed description of the device software, including
software applications and hardware-based devices that incorporate
software.
(vii) For devices with an intended use that includes detection of
Influenza A and Influenza B viruses and/or detection and differentiate
between the Influenza A virus subtypes in human clinical specimens, in
addition to detecting emerging respiratory pathogen(s), a detailed
description of the identity, phylogenetic relationship, or other
recognized characterization of the Influenza A and B viruses that the
device is designed to detect, a description of how the device results
might be used in a diagnostic algorithm and other measures that might
be needed for a laboratory identification of Influenza A or B virus and
of specific Influenza A virus subtypes, and a description of the
clinical and epidemiological parameters that are relevant to a patient
case diagnosis of Influenza A or B and of specific Influenza A virus
subtypes. Perform an evaluation of the device compared to a currently
appropriate and FDA accepted comparator method. Detailed documentation
must be kept of that study and its results, including the study
protocol, study report for the proposed intended use, testing results,
and results of all statistical analyses.
(4) For devices with an intended use that includes detection of
Influenza A and Influenza B viruses and/or detection and differentiate
between the Influenza A virus subtypes in human clinical specimens, in
addition to detecting emerging respiratory pathogen(s), the labeling
required under Sec. 809.10 of this chapter must include the following:
(i) Where applicable, a limiting statement that performance
characteristics for Influenza A were established when Influenza A/H3
and A/H1-2009 (or other pertinent Influenza A subtypes) were the
predominant Influenza A viruses in circulation. When other Influenza A
viruses are emerging, performance characteristics may vary.
(ii) Where applicable, a warning statement that reads if infection
with a novel Influenza A virus is suspected based on current clinical
and epidemiological screening criteria
[[Page 40713]]
recommended by public health authorities, specimens should be collected
with appropriate infection control precautions for novel virulent
influenza viruses and sent to state or local health departments for
testing. Viral culture should not be attempted in these cases unless a
BSL 3+ facility is available to receive and culture specimens.
(iii) Where the device results interpretation involves combining
the outputs of several targets to get the final results, such as a
device that both detects Influenza A and differentiates all known
Influenza A subtypes that are currently circulating, the device's
labeling required under Sec. 809.10(b)(9) of this chapter must include
a clear interpretation instruction for all valid and invalid output
combinations, and recommendations for any required follow up actions or
retesting in the case of an unusual or unexpected device result.
(iv) A limiting statement that if a specimen yields a positive
result for Influenza A, but produces negative test results for all
specific influenza A subtypes intended to be differentiated (e.g., H1-
2009 and H3), this result requires notification of appropriate local,
state, or federal public health authorities to determine necessary
measures for verification and to further determine whether the specimen
represents a novel strain of Influenza A.
(5) The manufacturer must perform annual analytical reactivity
testing of the device with contemporary influenza strains. This annual
analytical reactivity testing must meet the following criteria:
(i) The appropriate strains to be tested will be identified by FDA
in consultation with the Centers for Disease Control and Prevention
(CDC) and sourced from CDC or an FDA designated source. If the annual
strains are not available from CDC, FDA will identify an alternative
source for obtaining the requisite strains.
(ii) The testing must be conducted according to a standardized
protocol considered and determined by FDA to be acceptable and
appropriate.
(iii) By July 31 of each calendar year, the results of the last 3
years of annual analytical reactivity testing must be included as part
of the device's labeling. If a device has not been on the market long
enough for 3 years of annual analytical reactivity testing to have been
conducted since the device received marketing authorization from FDA,
then the results of every annual analytical reactivity testing since
the device received marketing authorization from FDA must be included.
The results must be presented as part of the device's labeling in a
tabular format, which includes the detailed information for each virus
tested as described in the certificate of authentication, either by:
(A) Placing the results directly in the device's labeling required
under Sec. 809.10(b) of this chapter that physically accompanies the
device in a separate section of the labeling where the analytical
reactivity testing data can be found; or
(B) In the device's label or in other labeling that physically
accompanies the device, prominently providing a hyperlink to the
manufacturer's public website where the analytical reactivity testing
data can be found. The manufacturer's home page, as well as the primary
part of the manufacturer's website that discusses the device, must
provide a prominently placed hyperlink to the web page containing this
information and must allow unrestricted viewing access.
(6) If one of the actions listed at section 564(b)(1)(A)-(D) of the
FD&C Act occurs with respect to an influenza viral strain, or if the
Secretary of Health and Human Services (HHS) determines, under section
319(a) of the Public Health Service Act, that a disease or disorder
presents a public health emergency, or that a public health emergency
otherwise exists, with respect to an influenza viral strain:
(i) Within 30 days from the date that FDA notifies manufacturers
that characterized viral samples are available for test evaluation, the
manufacturer must have testing performed on the device with those viral
samples in accordance with a standardized protocol considered and
determined by FDA to be acceptable and appropriate. The procedure and
location of testing may depend on the nature of the emerging virus.
(ii) Within 60 days from the date that FDA notifies manufacturers
that characterized viral samples are available for test evaluation and
continuing until 3 years from that date, the results of the influenza
emergency analytical reactivity testing, including the detailed
information for the virus tested as described in the certificate of
authentication, must be included as part of the device's labeling in a
tabular format, either by:
(A) Placing the results directly in the device's labeling required
under Sec. 809.10(b) of this chapter that physically accompanies the
device in a separate section of the labeling where analytical
reactivity testing data can be found, but separate from the annual
analytical reactivity testing results; or
(B) In a section of the device's label or in other labeling that
physically accompanies the device, prominently providing a hyperlink to
the manufacturer's public website where the analytical reactivity
testing data can be found. The manufacturer's home page, as well as the
primary part of the manufacturer's website that discusses the device,
must provide a prominently placed hyperlink to the web page containing
this information and must allow unrestricted viewing access.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16034 Filed 8-20-25; 8:45 am]
BILLING CODE 4164-01-P
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