Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens

Issuing agencies

Abstract

The Food and Drug Administration (FDA) is classifying the system for detection of nucleic acid from non-viral microorganism(s) causing sexually transmitted infections using home-collected 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 classification of the system for detection of nucleic acid from non-viral microorganism(s) causing sexually transmitted infections using home-collected specimens. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the 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 195 (Friday, October 9, 2026)</title>
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[Federal Register Volume 91, Number 195 (Friday, October 9, 2026)]
[Rules and Regulations]
[Pages 64611-64615]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20727]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2026-N-10996]


Medical Devices; Immunology and Microbiology Devices; 
Classification of the System for Detection of Nucleic Acid From Non-
Viral Microorganism(s) Causing Sexually Transmitted Infections Using 
Home-Collected Specimens

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 
system for detection of nucleic acid from non-viral microorganism(s) 
causing sexually transmitted infections using home-collected 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 classification of the system for detection of 
nucleic acid from non-viral microorganism(s) causing sexually 
transmitted infections using home-collected specimens. We are taking 
this action because we have determined that classifying the device into 
class II will provide a reasonable assurance of the 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 October 9, 2026. The classification was 
applicable on November 15, 2023.

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#2169484c404f480f6348524955614745400f4949520f464e57"><span class="__cf_email__" data-cfemail="d39bbabeb2bdbafd91baa0bba793b5b7b2fdbbbba0fdb4bca5">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA (the Agency or we) has classified the system for 
detection of nucleic acid from non-viral microorganism(s) causing 
sexually transmitted infections using home-collected specimens into 
class II (special controls), which we have determined will provide a 
reasonable assurance of the safety and effectiveness of the device. In 
addition, we believe this action will enhance patients' access to 
beneficial innovation, in part by

[[Page 64612]]

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 November 16, 2020, FDA received LetsGetChecked Inc.'s (formerly 
PrivaPath Diagnostics Inc.) request for De Novo classification of the 
Simple 2 Test. 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 the 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 November 15, 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 
866.3385.\1\ We have named the generic type of device ``system for 
detection of nucleic acid from non-viral microorganism(s) causing 
sexually transmitted infections using home-collected specimens,'' and 
it is identified as an in vitro diagnostic system intended for self-
collecting specimens in home settings or similar environments and 
testing in a clinical laboratory for detection of nucleic acids from 
non-viral microorganism(s) causing sexually transmitted infections. The 
device is intended to aid in the diagnosis of sexually transmitted 
infections. The device is intended for prescription use or over-the-
counter use.
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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 Systems for
    Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing
     Sexually Transmitted Infections Using Home-Collected Specimens
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       Identified risks to health              Mitigation measures
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Risk of false results..................  Certain labeling information
                                          including limitations, device
                                          descriptions, performance
                                          information, and explanations
                                          of procedures.
                                         Use of certain specimen
                                          collection devices.
                                         Certain design verification and
                                          validation including
                                          documentation of device
                                          descriptions, certain
                                          analytical studies and
                                          clinical studies, and risk
                                          analysis strategies.

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Failure to correctly interpret test      Certain labeling information
 results.                                 including limitations, device
                                          descriptions, performance
                                          information, and explanations
                                          of procedures.
                                         Use of certain specimen
                                          collection devices.
                                         Certain design verification and
                                          validation including
                                          documentation of device
                                          descriptions, certain
                                          analytical studies and
                                          clinical studies, and risk
                                          analysis strategies.
Failure to correctly operate the device  Certain labeling information
                                          including limitations, device
                                          descriptions, performance
                                          information, and explanations
                                          of procedures.
                                         Use of certain specimen
                                          collection devices.
                                         Certain design verification and
                                          validation including
                                          documentation of device
                                          descriptions, certain
                                          analytical studies and
                                          clinical studies, and risk
                                          analysis strategies.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of the 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.
    At the time of classification, systems for detection of nucleic 
acid from non-viral microorganism(s) causing sexually transmitted 
infections using home-collected specimens include systems that are 
intended for prescription use only. Prescription devices are subject to 
the prescription labeling requirements for in vitro diagnostic products 
(see 21 CFR 809.10(a)(4) and (b)(5)(ii)).
    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 systems for detection of 
nucleic acid from non-viral microorganism(s) causing sexually 
transmitted infections using home-collected specimens. 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.  866.3385 to subpart D to read as follows:


Sec.  866.3385   System for detection of nucleic acid from non-viral 
microorganism(s) causing sexually transmitted infections using home-
collected specimens.

    (a) Identification. This device is an in vitro diagnostic system 
intended for self-collecting specimens in home settings or similar 
environments and testing in a clinical laboratory for detection of 
nucleic acids from non-viral microorganism(s) causing sexually 
transmitted infections. The device is intended to aid in the diagnosis 
of sexually transmitted infections. The device is intended for 
prescription use or over-the-counter use.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The test must use a sample collection device that is FDA-
cleared, -approved, or -classified as 510(k) exempt with an indication 
for over-the-counter in vitro diagnostic use in molecular testing; 
alternatively, the sample collection device must be cleared in a 
premarket submission as a part of this device in which performance data 
demonstrate that lay users can correctly collect specimens without 
health care provider (HCP) supervision.
    (2) The intended use in the labeling required under Sec.  809.10 of 
this chapter must include a description of the following: the analytes 
the device detects and identifies, the clinical indications for which 
the test is to be used, the specimen types tested, the specific 
intended population(s), the name of the testing facility or facilities, 
as applicable, and other conditions of use as appropriate.
    (3) The intended use of the device must only include indications 
for testing of specimens that are appropriate for collection by lay 
users for which

[[Page 64614]]

there are performance data that demonstrate lay users can correctly 
collect specimens without HCP supervision.
    (4) Design verification and validation must include:
    (i) A detailed test description of test components, including 
reagents, instruments, ancillary materials, control elements, and a 
detailed explanation of the methodology, including pre-analytical 
methods for processing of specimens, microorganism target(s), 
identification of target detection reagents (e.g., primers), internal 
controls, and computational path from collected raw data to reported 
results (e.g., how collected raw signals are converted into a reported 
signal and result), as applicable to the detection method and device 
design.
    (ii) A description of the process from acquisition of the 
collection kit to results reporting.
    (iii) Detailed descriptions of the test procedure, the 
interpretation of test results for clinical specimens, and acceptance 
criteria for any quality control testing.
    (iv) Detailed documentation and test performance results from a 
clinical study that includes prospective self-collected samples for 
each claimed specimen type. This study must be performed on a study 
population consistent with the intended use population and compare the 
device's performance to results obtained using a comparator that FDA 
has determined is appropriate. Detailed documentation from the clinical 
study must include the clinical study protocol (including a predefined 
statistical analysis plan), study report, testing results, and results 
of statistical analyses.
    (v) Risk analysis and documentation demonstrating how risk control 
measures are implemented to address device system hazards, such as 
failure modes and effects analysis and/or hazard analysis. This must 
include information that demonstrates the effectiveness of risk control 
measures 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: usability studies, user label comprehension studies, and flex 
studies.
    (vi) Detailed documentation of analytical studies, including the 
limit of detection, inclusivity, cross-reactivity, microbial 
interference, interfering substances, competitive inhibition, 
carryover/cross-contamination, specimen stability, within-lab 
precision, and reproducibility, as applicable.
    (vii) Validation data to support specimen integrity during handling 
and shipping.
    (viii) Detailed documentation of reagent stability studies.
    (ix) For devices with associated software or instrumentation, 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, hazard analysis, and risk assessment activities.
    (5) The labeling required under Sec.  809.10(b) of this chapter 
must include the following:
    (i) Clear information written in appropriate language for the 
intended user that includes: instructions for sample collection and 
sample packaging for shipping and transport to the testing site; an 
explanation of test results and results interpretation, including 
instructions on what actions to take based on the test results; and 
information for technical assistance with the collection kit.
    (ii) A frequently asked questions section that provides technical 
and educational information (e.g., information about notifying sexual 
partners, how to prevent future infections, what to do if symptoms 
persist after treatment, directions to resources for further 
information on the disease and epidemiology).
    (iii) Warning and limitation statements, including the following:
    (A) A negative test result does not preclude the possibility of 
infection with other pathogens;
    (B) The test system is not a substitute for visits to a healthcare 
provider. The information provided by the product should not be used to 
start, stop, or change any course of treatment unless advised by the 
healthcare provider;
    (C) Anyone with recent sexual contact with a person known to have a 
sexually transmitted infection should visit a healthcare provider for 
treatment and evaluation as soon as possible (refer to professional 
guidelines);
    (D) Contact a healthcare provider prior to collecting the sample if 
the user has a condition that makes it difficult to use the test (e.g., 
problems with vision, handling the test components, or understanding 
test instructions or results);
    (E) Accurate results are dependent on adequate product storage and 
adherence to the specimen collection and testing procedures;
    (F) Failure to follow test procedures can lead to incorrect 
results; and
    (G) The home collection kit must not be used beyond the expiration 
date. Use of expired kits can lead to incorrect results.
    (iv) Accessioning criteria for acceptability of samples received by 
the laboratory (e.g., time from sample collection, transport media 
leakage, integrity of the sample).
    (6) The device's labeling must include a prominent hyperlink to the 
manufacturer's public website where the manufacturer must make the 
information identified in this section publicly and prominently 
available. The information must include, written in language 
appropriate for the intended user:
    (i) A brief summary of the purpose of the test.
    (ii) Detailed instructions for proper sample collection and 
shipping procedures, and interpretation of results.
    (iii) Required warnings and limitation statements.
    (iv) Contact information for technical assistance with the 
collection kit (e.g., helpline contact information).
    (v) For tests intended for over-the-counter use, information on who 
should and who should not use this test, and directions for further 
information for a user who might not be appropriate for testing using 
this device.
    (vi) For tests intended for over-the-counter use, information for 
users on any follow-up actions (e.g., a link for in-person consultation 
or telehealth visit with an HCP).
    (vii) The performance characteristics established in required 
studies.
    (viii) If appropriate (e.g., recommended by the Centers for Disease 
Control and Prevention, by current well-accepted clinical guidelines, 
or by published peer-reviewed research, as determined by FDA), 
information that the clinical performance is inferior in a specific 
clinical subpopulation or for a specific claimed specimen type.
    (ix) 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

[[Page 64615]]

    (D) Therapeutic failure or success cannot be determined based on 
the assay results, since nucleic acids may persist following 
appropriate antimicrobial therapy.
    (7) The outer box label required under Sec.  809.10(a) of this 
chapter must include the following:
    (i) A description of who may use the home collection kit and age of 
the intended users.
    (ii) A list of the components included.
    (iii) A list of the components required, but not provided (e.g., 
software applications needed to complete the process).
    (iv) A statement that this is a home sample collection kit which 
requires shipping of the sample to a laboratory within the specified 
timeframe to receive results.
    (v) A statement that anyone with recent sexual contact with a 
person known to have a sexually transmitted infection should visit a 
healthcare provider for treatment and evaluation as soon as possible 
(refer to professional guidelines).

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-20727 Filed 10-8-26; 8:45 am]
BILLING CODE 4164-01-P


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