Rule2025-08144
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Measure Non-Microbial Analytes To Aid in the Detection and Identification of Localized Human Infections
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Published
May 9, 2025
Effective
May 9, 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 device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections 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 the device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections' classification. We are taking this action because we have determined that classifying the device into class II (special controls) 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 89 (Friday, May 9, 2025)</title>
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[Federal Register Volume 90, Number 89 (Friday, May 9, 2025)]
[Rules and Regulations]
[Pages 19641-19643]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-08144]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2025-N-0781]
Medical Devices; Immunology and Microbiology Devices;
Classification of the Device To Detect and Measure Non-Microbial
Analytes To Aid in the Detection and Identification of Localized Human
Infections
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
classifying the device to detect and measure non-microbial analytes to
aid in the detection and identification of localized human infections
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 the device to detect and measure non-microbial
analytes to aid in the detection and identification of localized human
infections' classification. We are taking this action because we have
determined that classifying the device into class II (special controls)
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 May 9, 2025. The classification was
applicable on May 23, 2019.
FOR FURTHER INFORMATION CONTACT: Dina Jerebitski, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3574, Silver Spring, MD 20993-0002, 301-
796-2411, <a href="/cdn-cgi/l/email-protection#bafed3d4db94f0dfc8dfd8d3cec9d1d3fadcdedb94d2d2c994ddd5cc"><span class="__cf_email__" data-cfemail="16527f7877385c736473747f62657d7f56707277387e7e6538717960">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the device to detect and measure
non-microbial analytes to aid in the detection and identification of
localized human infections 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 (see 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.
Under either procedure for De Novo classification, FDA is required
to classify the device by written order
[[Page 19642]]
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 29, 2018, FDA received CD Diagnostics Inc.'s request for De
Novo classification of the Synovasure Alpha Defensin Lateral Flow Test
Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test),
Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure
Alpha Defensin Lateral Flow Test Kit (30 Test), and the Synovasure
Alpha Defensin Control Kit. 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 21 U.S.C. 360c(a)(1)(B)). 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 May 23, 2019, 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
866.3230.\1\ We have named the generic type of device ``Device to
detect and measure non-microbial analytes to aid in the detection and
identification of localized human infections,'' and it is identified as
an in vitro diagnostic device intended for the detection and
qualitative measurement, quantitative measurement, or both of one or
more non-microbial analytes in human clinical specimens to aid in the
assessment, identification, or both of a localized microbial infection
when used in conjunction with clinical signs and symptoms and other
clinical and laboratory findings.
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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
the 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--Device To Detect and Measure Non-Microbial Analytes To Aid in
the Detection and Identification of Localized Human Infections Risks and
Mitigation Measures
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Identified risks to health Mitigation measures
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Risk of false test results... Certain device descriptions, performance
characteristics, results interpretation
information, limitations, and study
details in labeling;
Certain device description information,
demographic analysis, validation
procedures, risk mitigation strategies
and end user trainings, and studies; and
Collection device specification.
Failure to interpret test Certain device descriptions, performance
results correctly. characteristics, results interpretation
information, limitations, and study
details in labeling; and
Certain demographic analysis, validation
procedures, risk mitigation strategies
and end user trainings, and studies.
Failure to operate the device Certain device descriptions, performance
correctly. characteristics, results interpretation
information, limitations, and study
details in labeling;
Certain demographic analysis, validation
procedures, risk mitigation strategies
and end user trainings, and studies; and
Collection device specification.
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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. 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 order. This device is 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 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 part 860, subpart D, regarding De Novo
[[Page 19643]]
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 the 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.
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. 866.3230 to subpart D to read as follows:
Sec. 866.3230 Device to detect and measure non-microbial analytes to
aid in the detection and identification of localized human infections.
(a) Identification. A device to detect and measure non-microbial
analytes to aid in the detection and identification of localized human
infections is identified as an in vitro diagnostic device intended for
the detection and qualitative measurement, quantitative measurement, or
both of one or more non-microbial analytes in human clinical specimens
to aid in the assessment, identification, or both of a localized
microbial infection when used in conjunction with clinical signs and
symptoms and other clinical and laboratory findings.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) 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 human specimens; alternatively, the
sample collection device must be cleared in a premarket submission as a
part of this device.
(2) The labeling required under Sec. 809.10(b) of this chapter
must include:
(i) An intended use with a detailed description of what the device
detects and measures, the type of results provided to the user, the
sample type, whether the measure is qualitative and/or quantitative,
the clinical indications for the test use, and the specific
population(s) for which the device is intended.
(ii) A detailed description of the performance characteristics of
the device for all intended specimen types from the analytical and
clinical studies (as applicable) required under paragraphs (b)(3)(ii)
and (iii) of this section.
(iii) A detailed explanation of the interpretation of results,
including acceptance criteria for evaluating the validity of individual
runs (e.g., assessment of internal and/or external quality controls, as
applicable).
(iv) The following limiting statements:
(A) A statement that a negative test result does not preclude the
possibility of infection;
(B) A statement that the test results should be interpreted in
conjunction with other clinical and laboratory data available to the
clinician;
(C) A statement that consistent device performance is dependent on
adequate specimen collection, transport, storage, and processing.
Failure to observe proper procedures in any one of these steps can lead
to incorrect results; and
(D) A statement that details any limitations associated with the
samples, as appropriate (e.g., collected on the day of admission to the
intensive care unit).
(3) Design verification and validation must include the following:
(i) A detailed device description, including as appropriate, all
device parts; control elements incorporated into the test procedure;
instrument requirements; reagents required but not provided; and the
principle of device operation and test methodology, including all
preanalytical methods for the processing of specimens and the
methodology from obtaining a sample to the result; design of primer/
probe sequences; rationale for target analyte selection; and
computational path from collected raw data to reported result (e.g.,
how collected raw signals are converted into a reported result).
(ii) Detailed documentation of analytical studies including
analytical sensitivity (Limit of Detection, Limit of Quantitation, and
Limit of Blank), inclusivity, cross-reactivity, microbial interference,
interfering substances, competitive inhibition, carryover/cross-
contamination, specimen stability, within-lab precision,
reproducibility, and linearity, as applicable.
(iii) Detailed documentation and results either from a clinical
study, that includes prospective (sequentially collected) samples for
each intended specimen type that are representative of the intended use
populations and, when determined to be acceptable by FDA, additional
characterized clinical samples; or, when determined to be acceptable by
FDA, an equivalent sample set. The clinical study must compare the
device performance to results obtained from an FDA-accepted reference
method and/or FDA-accepted comparator method, as appropriate.
Documentation from the clinical studies must include the clinical study
protocol (e.g., the predefined statistical analysis plan), clinical
study report, testing results, and results of all statistical analyses.
(iv) An evaluation of the level of the non-microbial analyte in
asymptomatic patients with demographic characteristics (e.g., age,
racial, ethnic, and sex distribution) similar to the intended use
population of the device.
(v) Documentation of an appropriate end user device training
program that will be offered as part of efforts to mitigate the risks
of false results, failure to operate the device correctly, and failure
to interpret test results correctly.
(vi) An appropriate risk mitigation strategy to ensure that the
device does not prevent any other device(s) with which it is indicated
for use, including incorporated device(s), from achieving their
intended use (e.g., safety and effectiveness of the functions of the
indicated device(s) remain unaffected).
(vii) A detailed description of the impact of any software,
including software applications and hardware-based devices that
incorporate software, on the device's functions.
Dated: May 5, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-08144 Filed 5-8-25; 8:45 am]
BILLING CODE 4164-01-P
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