Rule2025-10786
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Fungal Nucleic Acids Directly in Respiratory 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
June 13, 2025
Effective
June 13, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect and identify fungal nucleic acids directly in respiratory 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 the device to detect and identify fungal nucleic acids directly in respiratory specimens' 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 113 (Friday, June 13, 2025)</title>
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[Federal Register Volume 90, Number 113 (Friday, June 13, 2025)]
[Rules and Regulations]
[Pages 24966-24969]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10786]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2025-N-1262]
Medical Devices; Immunology and Microbiology Devices;
Classification of the Device To Detect and Identify Fungal Nucleic
Acids Directly in Respiratory Specimens
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, Agency, or we) is
classifying the device to detect and identify fungal nucleic acids
directly in respiratory 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 the device to
detect and identify fungal nucleic acids directly in respiratory
specimens' 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.
[[Page 24967]]
DATES: This order is effective June 13, 2025. The classification was
applicable on November 29, 2017.
FOR FURTHER INFORMATION CONTACT: Ryan Lubert, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3414, Silver Spring, MD 20993-0002, 240-402-6357,
<a href="/cdn-cgi/l/email-protection#613318000f4f2d1403041315210705004f0909124f060e17"><span class="__cf_email__" data-cfemail="52002b333c7c1e2730372026123436337c3a3a217c353d24">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the device to detect and identify
fungal nucleic acids directly in respiratory 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 (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 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 August 1, 2017, FDA received DxNA, LLC's request for De Novo
classification of the GeneSTAT.MDx Coccidioides Assay. 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 November 29, 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
866.3376.\1\ We have named the generic type of device a device to
detect and identify fungal nucleic acids directly in respiratory
specimens, and it is identified as an in vitro diagnostic device
intended for the detection and identification of fungal pathogens in
respiratory specimens collected from patients with signs or symptoms
and suspicion of fungal infection. The device is intended to aid in the
diagnosis of fungal disease in conjunction with clinical signs and
symptoms and other 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
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.
[[Page 24968]]
Table 1--Device To Detect and Identify Fungal Nucleic Acids Directly in
Respiratory 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 Special
identification of a pathogenic Controls (1) (21 CFR
microorganism by the device can lead 866.3376(b)(1)); (2)(i) (21 CFR
to improper patient management. 866.3376(b)(2)(i)); (2)(ii) (21
CFR 866.3376(b)(2)(ii));
(2)(iii) (21 CFR
866.3376(b)(2)(iii)); (2)(iv)
(21 CFR 866.3376(b)(2)(iv));
(2)(v) (21 CFR
866.3376(b)(2)(v)); (3)(i) (21
CFR 866.3376(b)(3)(i)); (3)(ii)
(21 CFR 866.3376(b)(3)(ii)); and
(3)(iii) (21 CFR
866.3376(b)(3)(iii).
Failure to correctly interpret test General Controls and Special
results. Controls (1) (21 CFR
866.3376(b)(1)); (2)(iii) (21
CFR 866.3376(b)(2)(iii));
(2)(iv) (21 CFR
866.3376(b)(2)(iv)); and (2)(v)
(21 CFR 866.3376(b)(2)(v)).
Failure to correctly operate the General Controls and Special
instrument. Controls (1) (21 CFR
866.3376(b)(1)); (2)(i) (21 CFR
866.3376(b)(2)(i)); (3)(ii) (21
CFR 866.3376(b)(3)(ii)); and
(3)(iii) (21 CFR
866.3376(b)(3)(iii).
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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 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 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. 866.3376 to subpart D to read as follows:
Sec. 866.3376 Device to detect and identify fungal nucleic acids
directly in respiratory specimens.
(a) Identification. A device to detect and identify fungal nucleic
acids directly in respiratory specimens is an in vitro diagnostic
device intended for the detection and identification of fungal
pathogens in respiratory specimens collected from patients with signs
or symptoms and suspicion of fungal infection. The device is intended
to aid in the diagnosis of fungal disease in conjunction with clinical
signs and symptoms and other laboratory findings.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) The intended use must include a detailed description of what
the device detects, the type of results provided to the user, the
clinical indications appropriate for test use, and the specific
population(s) and testing location(s) for which the device is intended.
(2) The labeling required under 21 CFR 809.10(b) must include:
(i) A detailed device description, including the parts that make up
the device, instrument requirements, ancillary reagents required but
not provided, and a detailed explanation of the methodology including
all pre-analytical methods for processing of specimens.
(ii) Performance characteristics from analytical studies, including
analytical sensitivity (Limit of Detection), inclusivity,
reproducibility, interference, cross-reactivity, interfering
substances, carryover/cross-contamination, and specimen stability.
(iii) A statement that the device is intended to be used in
conjunction with clinical history, signs and symptoms and the results
of other diagnostic tests.
(iv) A detailed explanation of the interpretation of test results
and acceptance criteria for any quality control testing.
(v) A limiting statement that negative results do not preclude the
possibility of infection, and should not be used as the sole basis for
diagnosis, treatment, or other patient management decisions.
(3) Design verification and validation activities must include:
(i) Performance characteristics from clinical studies that include
prospective (sequential) samples and, if appropriate, additional
characterized samples. The study must be performed on a study
population consistent with the intended use population and compare the
device performance to results obtained from comparator methods.
Documentation from the clinical studies must include the clinical study
protocol (including predefined statistical analysis plan), clinical
study report, and results of all statistical analyses.
(ii) A detailed device description of the following:
(A) Overall device design including all parts that make up the
device and all control elements incorporated into the testing
procedure.
(B) Thorough description of the methodology including, primer/probe
[[Page 24969]]
sequences, primer/probe design and rationale for target sequence
selection.
(C) 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.
(iii) A detailed documentation for device software, including,
software applications and hardware-based devices that incorporate
software.
Dated: June 9, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-10786 Filed 6-12-25; 8:45 am]
BILLING CODE 4164-01-P
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