Rule2025-08149
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect Nucleic Acids From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections and Associated Resistance Marker(s)
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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, Agency, or we) is classifying the device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s) 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 nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s)'s 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 19631-19634]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-08149]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2025-N-0814]
Medical Devices; Immunology and Microbiology Devices;
Classification of the Device To Detect Nucleic Acids From Non-Viral
Microorganism(s) Causing Sexually Transmitted Infections and Associated
Resistance Marker(s)
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 nucleic acids from non-viral
microorganism(s) causing sexually transmitted infections and associated
resistance marker(s) into class II (special controls). The special
controls that apply to the device type
[[Page 19632]]
are identified in this order and will be part of the codified language
for the device to detect nucleic acids from non-viral microorganism(s)
causing sexually transmitted infections and associated resistance
marker(s)'s 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 January 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#eaae83848bc4a08f988f88839e998183aa8c8e8bc4828299c48d859c"><span class="__cf_email__" data-cfemail="cb8fa2a5aae581aeb9aea9a2bfb8a0a28badafaae5a3a3b8e5aca4bd">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the device to detect nucleic acids
from non-viral microorganism(s) causing sexually transmitted infections
and associated resistance marker(s) 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 31, 2018, FDA received Hologic, Inc.'s request for De
Novo classification of the Aptima Mycoplasma genitalium 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 January 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
866.3393.\1\ We have named the generic type of device ``device to
detect nucleic acids from non-viral microorganism(s) causing sexually
transmitted infections and associated resistance marker(s),'' and it is
identified as an in vitro diagnostic device intended for the detection
and identification of nucleic acids from non-viral microorganism(s) and
their associated resistance markers in clinical specimens collected
from patients suspected of sexually transmitted infections. The device
is intended to aid in the diagnosis of non-viral sexually transmitted
infections in conjunction with other clinical and laboratory data.
These devices do not provide confirmation of antibiotic susceptibility
since mechanisms of resistance may exist that are not detected by the
device.
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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
[[Page 19633]]
required to mitigate these risks in table 1.
Table 1--Device To Detect Nucleic Acids From Non-Viral Microorganism(s)
Causing Sexually Transmitted Infections and Associated Resistance
Marker(s) Risks and Mitigation Measures
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Identified risk to health Mitigation measures
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Risk of false results........ General controls and special controls (1)
(21 CFR 866.3393(b)(1)), (2) (21 CFR
866.3393(b)(2)), (3) (21 CFR
866.3393(b)(3)), and (4) (21 CFR
866.3393(b)(4)).
Failure to correctly General controls and special controls (1)
interpret test results. (21 CFR 866.3393(b)(1)), (3)(iii) (21
CFR 866.3393(b)(3)(iii)), (3)(iv) (21
CFR 866.3393(b)(3)(iv)), and (3)(v) (21
CFR 866.3393(b)(3)(v)).
Failure to correctly operate General controls and special controls (1)
the device. (21 CFR 866.3393(b)(1)), (3)(i) (21 CFR
866.3393(b)(3)(i)), and (4) (21 CFR
866.3393(b)(4)).
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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, subpart 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.
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. 866.3393 to subpart D to read as follows:
Sec. 866.3393 Device to detect nucleic acids from non-viral
microorganism(s) causing sexually transmitted infections and associated
resistance marker(s).
(a) Identification. A device to detect nucleic acids from non-viral
microorganism(s) causing sexually transmitted infections and associated
resistance marker(s) is an in vitro diagnostic device intended for the
detection and identification of nucleic acids from non-viral
microorganism(s) and their associated resistance markers in clinical
specimens collected from patients suspected of sexually transmitted
infections. The device is intended to aid in the diagnosis of non-viral
sexually transmitted infections in conjunction with other clinical and
laboratory data. These devices do not provide confirmation of
antibiotic susceptibility since mechanisms of resistance may exist that
are not detected by the device.
(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 detailed description of targets the
device detects, the results provided to the user, the clinical
indications appropriate for test use, and the specific population(s)
for which the device is intended.
(2) 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.
(3) The labeling required under Sec. 809.10(b) of this chapter
must include:
(i) A detailed 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 discussion of the performance characteristics of the
device for all claimed specimen types based on analytical studies,
including Limit of Detection, inclusivity, cross-reactivity,
interfering substances, competitive inhibition, carryover/cross
contamination, specimen stability, within lab precision, and
reproducibility, as appropriate;
(iii) Detailed descriptions of the test procedure, the
interpretation of test results for clinical specimens, and acceptance
criteria for any quality control testing;
(iv) Limiting statements indicating that:
(A) A negative test result does not preclude the possibility of
infection;
(B) The test results should be interpreted in conjunction with
other clinical and laboratory data available to the clinician;
(C) Reliable results are 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) If appropriate (e.g., recommended by the Centers for Disease
Control and
[[Page 19634]]
Prevention, by current well-accepted clinical guidelines, or by
published peer reviewed research), that the clinical performance is
inferior in a specific clinical subpopulation or for a specific claimed
specimen type; and
(v) If the device is intended to detect antimicrobial resistance
markers, limiting statements, as appropriate, indicating that:
(A) Negative results for claimed resistance markers do not indicate
susceptibility of detected microorganisms, as resistance markers not
measured by the assay or other potential mechanisms of antibiotic
resistance may be present;
(B) Detection of resistance markers cannot be definitively linked
to specific microorganisms and the source of a detected resistance
marker may be an organism not detected by the assay, including
colonizing flora;
(C) Detection of antibiotic resistance markers may not correlate
with phenotypic gene expression; and
(D) Therapeutic failure or success cannot be determined based on
the assay results, since nucleic acid may persist following appropriate
antimicrobial therapy.
(4) Design verification and validation must include:
(i) Detailed device description documentation, including
methodology from obtaining sample to result, design of primer/probe
sequences, rationale for target sequence 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, Limit
of Detection, inclusivity, cross-reactivity, microbial interference,
interfering substances, competitive inhibition, carryover/cross
contamination, specimen stability, within lab precision, and
reproducibility, as appropriate.
(iii) Detailed documentation and performance results from a
clinical study that includes prospective (sequential) samples for each
claimed specimen type and, when determined to be appropriate by FDA,
additional characterized clinical 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 FDA accepted
comparator methods. Documentation from the clinical studies must
include the clinical study protocol (including a predefined statistical
analysis plan) study report, testing results, and results of all
statistical analyses.
(iv) 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. 2025-08149 Filed 5-8-25; 8:45 am]
BILLING CODE 4164-01-P
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