Rule2026-11739
Medical Devices; Immunology and Microbiology Devices; Classification of the Simple Point-of-Care Device to Directly Detect SARS-CoV-2 Viral Targets From Clinical Specimens in Near-Patient Settings
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
June 11, 2026
Effective
June 11, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is classifying the simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings 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 simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings. 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 91 Issue 112 (Thursday, June 11, 2026)</title>
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[Federal Register Volume 91, Number 112 (Thursday, June 11, 2026)]
[Rules and Regulations]
[Pages 35387-35391]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-11739]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2026-N-6238]
Medical Devices; Immunology and Microbiology Devices;
Classification of the Simple Point-of-Care Device to Directly Detect
SARS-CoV-2 Viral Targets From Clinical Specimens in Near-Patient
Settings
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
simple point-of-care device to directly detect SARS-CoV-2 viral targets
from clinical specimens in near-patient settings 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 simple point-of-care device to directly detect
SARS-CoV-2 viral targets from clinical specimens in near-patient
settings. 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 June 11, 2026. The classification was
applicable on March 8, 2023.
FOR FURTHER INFORMATION CONTACT: Uwe Scherf, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3110, Silver Spring, MD 20993-0002, 301-796-5456,
<a href="/cdn-cgi/l/email-protection#3e6b495b106d5d565b4c587e585a5f1056564d10595148"><span class="__cf_email__" data-cfemail="297c5e4c077a4a414c5b4f694f4d480741415a074e465f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the simple
point-of-care device to directly detect SARS-CoV-2 viral targets from
clinical specimens in near-patient settings into class II (special
controls), which we have determined will provide a reasonable assurance
of safety and effectiveness of the device. 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 into, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (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
[[Page 35388]]
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
classification 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 premarket
notification (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.
Under either procedure for De Novo classification, FDA is required
to 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 section 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 June 16, 2022, FDA received Quidel Corporation's request for De
Novo classification of the Sofia 2 SARS Antigen+ FIA and Sofia 2 SARS
Antigen+ FIA Control Swab Set. 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 of the device, 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 March 8, 2023, 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
866.3982.\1\ We have named the generic type of device ``simple point-
of-care device to directly detect SARS-CoV-2 viral targets from
clinical specimens in near-patient settings,'' and it is identified as
an in vitro diagnostic device for the direct detection of SARS-CoV-2 in
clinical specimens and is intended as an aid in the diagnosis of SARS-
CoV-2 infections (COVID-19). The device is simple to use and does not
involve sample manipulation, transportation of the sample to another
functional area (e.g., a central laboratory or other specialized area),
or measurement of reagents or analytes that could be affected by
conditions such as sample turbidity or cell lysis. The design and
procedures of the device are appropriate for use by healthcare
professionals in near-patient settings outside a centralized
laboratory.
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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 risks to health associated with this type of
device and the measures required to mitigate these risks in table 1.
Table 1--Risks to Health and Mitigation Measures for Simple Point-of-
Care Device to Directly Detect SARS-CoV-2 Viral Targets From Clinical
Specimens in Near-Patient Settings
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Identified risks to health Mitigation measures
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False results................................ Certain labeling
information including
limitations, device
descriptions,
explanations of
procedures and
performance information
identified in special
controls (1) and (4).
Use of certain specimen
collection devices
identified in special
control (3).
Certain design
verification and
validation including
documentation of device
descriptions, certain
analytical studies and
clinical studies, risk
analysis strategies
identified in special
control (5).
Testing of characterized
viral samples and
labeling information
identified in special
control (6).
Failure to correctly interpret test results.. Certain labeling
information including
limitations, device
descriptions,
explanations of
procedures and
performance information
identified in special
controls (1) and (4).
Use of certain specimen
collection devices
identified in special
control (3).
Certain design
verification and
validation including
documentation of device
descriptions, certain
analytical studies and
clinical studies, risk
analysis strategies
identified in special
control (5).
Failure to correctly operate the device...... Certain labeling
information including
limitations, device
descriptions,
explanations of
procedures and
performance information
identified in special
controls (1), (2), and
(4).
[[Page 35389]]
Use of certain specimen
collection devices
identified in special
control (3).
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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 of the device. 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.
Under the FD&C Act, submission of a premarket notification under
section 510(k) is required to reasonably assure the safety and
effectiveness of class II devices unless FDA determines that the device
type should be exempt under section 510(m) of the FD&C Act. At this
time FDA has not made this determination for simple point-of-care
devices to directly detect SARS-CoV-2 viral targets from clinical
specimens in near-patient settings. This device is therefore subject to
premarket notification requirements under section 510(k) of the FD&C
Act.
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 normally 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 management 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.
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. 866.3982 to subpart D to read as follows:
Sec. 866.3982 Simple point-of-care device to directly detect SARS-
CoV-2 viral targets from clinical specimens in near-patient settings.
(a) Identification. A simple point-of-care device to detect SARS-
CoV-2 viral targets directly from clinical specimens in near-patient
settings is an in vitro diagnostic device for the direct detection of
SARS-CoV-2 in clinical specimens and is intended as an aid in the
diagnosis of SARS-CoV-2 infections (COVID-19). The device is simple to
use and does not involve sample manipulation, transportation of the
sample to another functional area (e.g., a central laboratory or other
specialized area), or measurement of reagents or analytes that could be
affected by conditions such as sample turbidity or cell lysis. The
design and procedures of the device are appropriate for use by
healthcare professionals in near-patient settings outside a centralized
laboratory.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) The intended use in the labeling required under Sec. 809.10 of
this chapter must include a description of the following: analytes the
device detects and identifies, the specimen types tested, the results
provided to the user, the clinical indications for which the test is to
be used, the specific intended population(s), the intended use
locations including testing location(s) where the device is to be used
(if applicable), and other conditions of use as appropriate.
(2) The intended use of the device must only include indications
for testing of respiratory specimens.
(3) If sample collection devices are used, any sample collection
device used must be FDA-cleared, -approved, or -classified as 510(k)
exempt (standalone or as part of a test system) for the collection of
specimen types claimed by this device; alternatively, the sample
collection device must be cleared in a premarket submission as a part
of this device.
(4) The labeling required under Sec. 809.10(b) of this chapter
must include:
(i) A detailed and comprehensive device description, including
reagents, instruments, ancillary materials, all control elements, and a
detailed explanation of the methodology, including all pre-analytical
methods for processing of specimens;
(ii) Detailed descriptions of the performance characteristics of
the device for each specimen type claimed in the intended use based on
analytical studies including the following, as applicable: limit of
detection, inclusivity, cross-reactivity, interfering substances,
competitive inhibition, hook-effect, carryover/cross contamination,
specimen stability, precision, reproducibility, human factors analysis,
flex studies, and clinical studies;
(iii) Detailed descriptions of the test procedure(s), the
interpretation of test results for clinical specimens, and acceptance
criteria for any quality control testing;
(iv) A statement in the intended use that positive results do not
preclude co-infection with bacteria or other viruses and should not be
used as the sole basis for diagnosis, treatment, or other patient
management decisions;
(v) Detailed instructions for minimizing the risk of user's
exposure to infectious microbial agents that may be present in test
specimens and those used as control materials;
(vi) Detailed instructions for minimizing the risk of generating
false positive test results due to carry-over
[[Page 35390]]
contamination from positive test specimens and/or positive control
materials, as applicable to the design of the test device;
(vii) A brief reference sheet (Quick Reference Instructions) for
the intended user(s) that includes, at a minimum, the name and intended
use of the test, easy to follow step-by-step instructions of all
control and sample testing procedures for the claimed sample types,
including graphic illustrations targeted towards lay users (as
applicable), the result(s) interpretation guidance, warnings and
limitation statements, toxicology information and safety considerations
for any hazardous materials, information for troubleshooting (e.g.,
Frequently Asked Questions), and technical assistance with the device
(e.g., Help-line contact information);
(viii) Limiting statements indicating that:
(A) For those devices intended for testing in symptomatic subjects,
a statement that specifies the number of days post symptom onset
validated for use of the device and/or a range in which the performance
of the test is known;
(B) A negative test result does not preclude the possibility of
infection with other bacteria or viruses;
(C) The test results should be interpreted in conjunction with
other clinical and laboratory data available to the healthcare provider
(as applicable);
(D) There is a risk of erroneous results (i.e., false negatives)
due to the presence of novel, emerging respiratory viral variants
(e.g., specific strains or isolates);
(E) False positive test results are more likely when prevalence of
upper respiratory infection is low in the community;
(F) Accurate results are dependent on adequate specimen collection,
transport, storage, and processing (as applicable). Failure to observe
proper procedures in any one of these steps can lead to incorrect
results;
(G) This test should not be used beyond the expiration date listed
on the packaging. Use of expired tests can lead to incorrect results;
and
(H) The performance characteristics for that analyte were
established when [insert predominant strain, subtype, or variant] was
prevalent and that due to the propensity of the virus to mutate, new
strains emerge over time which may affect the performance of this
device and have serious public health implications. Additional testing
with a molecular test and/or sequencing should be considered in
situations where a new virus strain or variant is suspected.
(5) Design verification and validation must include:
(i) A detailed device description, including device components,
ancillary reagents required but not provided, and a detailed
explanation of the methodology, including viral target(s),
identification of target detection reagents (e.g., primers,
antibodies), 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
to the detection method and device design;
(ii) Detailed documentation of data from a prospective multisite
clinical study with a design and performance that is appropriate for
the intended use of the device, including performance estimates derived
from a sufficient number of samples from the intended use population
for each claimed specimen type. Results must be obtained from a
geographically diverse population, such that the performance of the
test device is appropriately representative of all present, circulating
strains of the target respiratory virus, at the time of the study and
submission. The clinical study must be consistent with and support the
intended use population and intended operators (as applicable) and must
be conducted in a representative intended use setting. The clinical
study must compare the results of the candidate device to results
obtained using an FDA accepted molecular comparator method. Detailed
documentation must include the clinical study protocol (including a
predefined statistical analysis plan), study report, testing results,
and results of all statistical analyses;
(iii) The clinical study designs, including number of samples
tested, must be sufficient to meet either of the following criteria:
(A) The lower bound of the two-sided 95 percent confidence interval
of the positive percent agreement must be greater than or equal to 80
percent and appropriate risk mitigation measures are established (e.g.,
presumptive negative results); or
(B) The lower bound of the two-sided 95 percent confidence interval
of the positive percent agreement must be greater than or equal to 70
percent and additional and appropriate risk mitigations measures are
established (e.g., presumptive negative results and serial testing).
(iv) Detailed documentation of analytical studies, including those
demonstrating the limit of detection, inclusivity (including relevant
variants), cross-reactivity, microbial interference, interfering
substances, competitive inhibition, specimen stability, within-lab
precision, hook effect, carryover, cross contamination, and site-to-
site reproducibility, as applicable;
(v) Detailed documentation and characterization (e.g.,
determination of the identity, supplier, purity, and stability) of all
critical reagents and protocols for maintaining product integrity
throughout its labeled shelf life, i.e., reagent stability studies.
Data and protocols, including acceptance criteria, from a multi-lot
reagent stability study must include testing of samples with adequately
challenging analyte concentration, be provided as part of the
regulatory submission and must include in-use/open-kit stability,
shipping stability, and freeze-thaw stability (as applicable). The
shelf-life stability assessment must include the most challenging
sample type identified in the device's intended use and are formulated
using whole virus;
(vi) Final release criteria to be used for manufactured test lots
with appropriate evidence that lots released at the extremes of the
specifications will meet the claimed analytical and clinical
performance characteristics as well as the stability claims;
(vii) Risk analysis and documentation demonstrating how risk
control measures are implemented to address device system hazards, such
as Failure Modes Effects Analysis and/or Hazard Analysis.
(A) This documentation must include a detailed description of a
protocol (including all procedures and methods) for the continuous
monitoring, identification, and handling of genetic mutations and/or
novel isolates or strains (e.g., regular review of published literature
and periodic in silico analysis of target sequences to detect possible
mismatches). Protocols must include plans to update labeling with
additional performance data. All results of this protocol, including
any findings, must be documented and must include any additional data
analysis that is requested by FDA in response to any performance
concerns identified under this section or identified by FDA during
routine evaluation. Additionally, if requested by FDA, these
evaluations must be submitted to FDA for FDA review within 48 hours of
the request. Results that are reasonably interpreted to support the
conclusion that novel respiratory pathogen strains or isolates impact
the stated expected performance of the device must be sent to FDA
immediately;
(B) This must include detailed documentation that demonstrates the
effectiveness of risk control measures
[[Page 35391]]
and device robustness, including the entire testing procedure from
sampling to result interpretation, based on results from the following
studies, as applicable per the intended use of the test device: human
factors engineering (e.g., usability studies and user label
comprehension), flex studies, and performance with weakly-reactive
samples in the hands of the intended user(s);
(viii) For devices with associated software or instrumentation,
documentation must include a detailed description of device software,
including software applications and hardware-based devices that
incorporate software. The detailed description must include
documentation of verification, validation, and hazard analysis and risk
assessment activities, including an assessment of the impact of threats
and vulnerabilities on device functionality and end users/patients as
part of cybersecurity review; and
(ix) For devices intended for the detection and identification of
an analyte for which an FDA recommended reference material is
available, design verification and validation must include the
performance results of an analytical study testing the FDA recommended
reference material. 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.
(6) If one of the actions listed in section 564(b)(1)(A) through
(D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to
one or more of the analytes claimed in the intended use, or if the
Secretary of Health and Human Services 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 one or more of the analytes claimed in the
intended use:
(i) Within 30 days from the date that FDA notifies manufacturers
that characterized samples are available for test evaluation, the
manufacturer must have testing performed on the device with those
samples in accordance with a standardized protocol considered and
determined by FDA to be acceptable and appropriate; and
(ii) Within 60 days from the date that FDA notifies manufacturers
that characterized samples are available for test evaluation and
continuing until 3 years from that date, the results of the emergency
analytical reactivity testing, including the detailed information for
the samples tested as described in the certificate of authentication,
must be included as part of the device's labeling in a tabular format.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-11739 Filed 6-10-26; 8:45 am]
BILLING CODE 4164-01-P
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