Rule2026-08811
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Preserve and Stabilize Relative Abundances of Microbial Nucleic Acids in Clinical Samples
Primary source
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Published
May 6, 2026
Effective
May 6, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is classifying the device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples 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 device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples. 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 87 (Wednesday, May 6, 2026)</title>
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[Federal Register Volume 91, Number 87 (Wednesday, May 6, 2026)]
[Rules and Regulations]
[Pages 24341-24343]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-08811]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2026-N-4644]
Medical Devices; Immunology and Microbiology Devices;
Classification of the Device To Preserve and Stabilize Relative
Abundances of Microbial Nucleic Acids in Clinical Samples
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
device to preserve and stabilize relative abundances of microbial
nucleic acids in clinical samples 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 device to preserve and stabilize relative abundances of microbial
nucleic acids in clinical samples. 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 May 6, 2026. The classification was
applicable on November 3, 2021.
FOR FURTHER INFORMATION CONTACT: Himani Bisht, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3106, Silver Spring, MD 20993-0002, 301-796-6189,
<a href="/cdn-cgi/l/email-protection#df97b6b2beb1b6f19db6acb7ab9fb9bbbef1b7b7acf1b8b0a9"><span class="__cf_email__" data-cfemail="48002125292621660a213b203c082e2c296620203b662f273e">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the device to
preserve and stabilize relative abundances of microbial nucleic acids
in clinical samples 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 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 15, 2020, FDA received DNA Genotek Inc.'s request for De
Novo classification of the OMNIgene GUT Dx device. 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
[[Page 24342]]
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 3, 2021, 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
866.2952.\1\ We have named the generic type of device ``device to
preserve and stabilize relative abundances of microbial nucleic acids
in clinical samples,'' and it is identified as a device that consists
of a container and reagents intended to stabilize microbial nucleic
acids for the subsequent assessment of the relative abundance of
microbial nucleic acids (i.e., microbiome) in human specimens by an
assay validated for use with the device. The device may also be
indicated for sample collection. The device is not intended for
preserving morphology or viability of microorganisms.
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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 Devices To Preserve
and Stabilize Relative Abundances of Microbial Nucleic Acids in Clinical
Samples
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Identified risks to health Mitigation measures
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Failure to correctly operate the device Certain labeling information,
leading to inadequate sample including warnings and device
collection. descriptions.
Certain design verification and
validation studies.
Failure to stabilize microbial nucleic Certain design verification and
acid resulting in an inaccurate assay validation studies.
result.
Device use with unvalidated or Certain labeling information,
incompatible assays leading to including warnings, device
inaccurate assay results and improper descriptions, and study
patient management. information.
Malfunction of the collection device Certain labeling information,
may lead to possible exposure to including warnings and device
infectious pathogens by laboratorians descriptions.
or individuals collecting fecal
samples.
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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 devices to preserve and
stabilize relative abundances of microbial nucleic acids in clinical
samples. 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. 866.2952 to subpart C to read as follows:
Sec. 866.2952 Device to preserve and stabilize relative abundances of
microbial nucleic acids in clinical samples.
(a) Identification. A device to preserve and stabilize relative
abundances of microbial nucleic acids in clinical samples is a device
that consists of a container and reagents intended to stabilize
microbial nucleic acids for the subsequent assessment of the relative
abundance of microbial nucleic acids (i.e., microbiome) in human
specimens by an assay validated for use with the device. The device may
also be indicated for sample collection. The device is not intended for
preserving morphology or viability of microorganisms.
[[Page 24343]]
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) The intended use on the device's label and labeling required
under Sec. 809.10 of this chapter must include a detailed description
of the type(s) of human specimens intended for collection and
preservation, and the characteristics of the microbial population
intended for subsequent analysis.
(2) The labeling required under Sec. 809.10(b) of this chapter
must include:
(i) A detailed device description, including reagents, ancillary
reagents required but not provided, and all other parts that make up
the device.
(ii) A warning statement that the device is not for the detection
of specific microbial pathogens.
(iii) A warning statement that the device should only be used with
legally marketed assays that are indicated for use with the device,
including, as appropriate, indicated for the relevant storage and
transport conditions.
(iv) Description of the microorganisms used for studies, including
the results and performance summaries, required under paragraph
(b)(3)(i) of this section.
(3) Design verification and validation must include:
(i) Detailed documentation and results from studies used for device
validation. This detailed documentation must include a detailed
identification of each of the following (which must be representative
of the spectrum of situations in which the device might be used that
are within the scope of the device's intended use): the panel of
microorganisms, the extraction platforms, the assay protocols used to
measure the stabilization of relative ratios (relative abundance) of
the microorganisms in the sample, and the bioinformatic pipelines used
in the validation studies for the determination of relative abundances
of preserved nucleic acids.
(ii) For devices intended for the collection of samples, detailed
documentation and results from studies that demonstrate the device's
usability, including user collection studies that demonstrate that the
user instructions are appropriate for the intended collection methods
(e.g., self-collection or clinician/laboratory collection) and users.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-08811 Filed 5-5-26; 8:45 am]
BILLING CODE 4164-01-P
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