Rule2025-16030
Medical Devices; Immunology and Microbiology Devices; Classification of the Device That Detects Nucleic Acid Sequences From Microorganisms Associated With Vaginitis and Bacterial Vaginosis
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Published
August 21, 2025
Effective
August 21, 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 that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis 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 that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis's classification. 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 90 Issue 160 (Thursday, August 21, 2025)</title>
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[Federal Register Volume 90, Number 160 (Thursday, August 21, 2025)]
[Rules and Regulations]
[Pages 40726-40728]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16030]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2025-N-2106]
Medical Devices; Immunology and Microbiology Devices;
Classification of the Device That Detects Nucleic Acid Sequences From
Microorganisms Associated With Vaginitis and Bacterial Vaginosis
AGENCY: Food and Drug Administration, 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 that detects nucleic acid sequences from
microorganisms associated with vaginitis and bacterial vaginosis 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 that detects nucleic acid sequences
from microorganisms associated with vaginitis and bacterial vaginosis's
classification. 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 August 21, 2025. The classification was
applicable on October 28, 2016.
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#bdefc4dcd393f1c8dfd8cfc9fddbd9dc93d5d5ce93dad2cb"><span class="__cf_email__" data-cfemail="42103b232c6c0e3720273036022426236c2a2a316c252d34">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the device that detects nucleic
acid sequences from microorganisms associated with vaginitis and
bacterial vaginosis 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
[[Page 40727]]
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 (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 shall
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 January 12, 2016, FDA received GeneOhm Sciences Canada, Inc. (BD
Diagnostics)'s request for De Novo classification of the BD Max Vaginal
Panel. 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 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 general controls, will provide reasonable assurance of the
safety and effectiveness of the device.
Therefore, on October 28, 2016, FDA issued an order to the
requestor classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
866.3975.\1\ We have named the generic type of device ``device that
detects nucleic acid sequences from microorganisms associated with
vaginitis and bacterial vaginosis,'' and it is identified as a
qualitative in vitro diagnostic device intended for the detection of
microbial nucleic acid sequences in vaginal specimens collected from
patients with signs and symptoms of vaginitis or bacterial vaginosis.
This device is intended to aid in the diagnosis of vaginitis or
bacterial vaginosis when used 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.
Table 1--Device That Detects Nucleic Acid Sequences From Microorganisms
Associated With Vaginitis and Bacterial Vaginosis 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).
microorganism by the device can lead to
improper patient management.
Failure to correctly interpret test General controls and special
results. controls (2).
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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 final order. This device is subject to
[[Page 40728]]
premarket notification requirements under section 510(k) of the FD&C
Act.
III. 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. 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 21 CFR part 866 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 866.3975 to subpart D to read as follows:
Sec. 866.3975 Device that detects nucleic acid sequences from
microorganisms associated with vaginitis and bacterial vaginosis.
(a) Identification. A device that detects nucleic acid sequences
from microorganisms associated with vaginitis and bacterial vaginosis
is a qualitative in vitro diagnostic device intended for the detection
of microbial nucleic acid sequences in vaginal specimens collected from
patients with signs and symptoms of vaginitis or bacterial vaginosis.
This device is intended to aid in the diagnosis of vaginitis or
bacterial vaginosis when used 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) Design verification and validation must include:
(i) Documentation with a detailed device description of device
components; ancillary reagents required but not provided; and
explanation of the methodology including primer/probe sequence, design,
and rationale for sequence selection.
(ii)Documentation with information that demonstrates the
performance characteristics of the device, including:
(A)Limit of Detection;
(B)Precision (reproductivity);
(C)Analytical specificity;
(D) Analytical reactivity (inclusivity);
(E) Specimen stability; and
(F) Effects of interfering substances.
(iii) Detailed documentation from a prospective clinical study. As
appropriate to the intended use, the prospective clinical study must be
performed on an appropriate study population, including women of
various ages and ethnicities. The prospective clinical study must
compare the device performance to results obtained from well-accepted
comparator methods.
(iv) Detailed documentation for device software, including software
applications and hardware-based devices that incorporate software.
(2) The labeling required under Sec. 809.10(b) of this chapter
must include:
(i) A detailed explanation of the interpretation of results and
acceptance criteria;
(ii) For devices with an intended use that includes detection of
nucleic acid sequences from bacteria associated with bacterial
vaginosis, clinical performance stratified by patient demographics such
as race, ethnicity, age, and pregnancy status.
(iii) For devices with an intended use that includes detection of
nucleic acid sequences from bacteria associated with bacterial
vaginosis, a summary of device results in an asymptomatic population
with demographic characteristics appropriate to the intended use
population.
(iv) For devices with an intended use that includes detection of
either Candida species or bacteria associated with bacterial vaginosis,
a limitation that Candida species and bacterial compositions associated
with bacterial vaginosis can be present as part of normal vaginal flora
and results should be considered in conjunction with available clinical
information.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16030 Filed 8-20-25; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on August 21, 2025.
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