Rule2026-09335
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganism Nucleic Acids and Resistance Markers From Patients With Suspected Orthopedic Infection
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Published
May 12, 2026
Effective
May 12, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is classifying the device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection 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 detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection. 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 91 (Tuesday, May 12, 2026)</title>
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[Federal Register Volume 91, Number 91 (Tuesday, May 12, 2026)]
[Rules and Regulations]
[Pages 25783-25785]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-09335]
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Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
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Federal Register / Vol. 91, No. 91 / Tuesday, May 12, 2026 / Rules
and Regulations
[[Page 25783]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2026-N-4274]
Medical Devices; Immunology and Microbiology Devices;
Classification of the Device To Detect and Identify Microorganism
Nucleic Acids and Resistance Markers From Patients With Suspected
Orthopedic Infection
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 detect and identify microorganism nucleic acids and
resistance markers from patients with suspected orthopedic infection
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 detect and
identify microorganism nucleic acids and resistance markers from
patients with suspected orthopedic infection. 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 12, 2026. The classification was
applicable on April 29, 2022.
FOR FURTHER INFORMATION CONTACT: Bryan Grabias, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3204, Silver Spring, MD 20993-0002, 240-402-9563,
<a href="/cdn-cgi/l/email-protection#2c6e5e554d42026b5e4d4e454d5f6c4a484d0244445f024b435a"><span class="__cf_email__" data-cfemail="5c1e2e253d32721b2e3d3e353d2f1c3a383d7234342f723b332a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the device to
detect and identify microorganism nucleic acids and resistance markers
from patients with suspected orthopedic infection 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 October 27, 2020, FDA received BioFire Diagnostics, LLC's
request for De Novo classification of the BioFire Joint Infection (JI)
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.
[[Page 25784]]
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 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 April 29, 2022, 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
866.3988.\1\ We have named the generic type of device ``device to
detect and identify microorganism nucleic acids and resistance markers
from patients with suspected orthopedic infection,'' and it is
identified as a qualitative in vitro device intended to simultaneously
detect and identify microorganism nucleic acids from human clinical
specimens collected from patients with suspected orthopedic infection.
The device detects specific nucleic acid sequences for microorganism
identification as well as markers for antimicrobial resistance. This
device is intended to aid in the diagnosis of orthopedic infections
when used in conjunction with other clinical signs and symptoms and
other laboratory findings. However, the device does not replace
traditional methods for culture and susceptibility testing.
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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 Detect
and Identify Microorganism Nucleic Acids and Resistance Markers From
Patients With Suspected Orthopedic Infection
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Identified risks to health Mitigation measures
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Risk of false test results leading Use of certain specimen collection
to improper patient management. devices identified in special
control (1).
Certain labeling information
identified in special control (2),
including limitations, warnings,
device descriptions, explanation of
procedures, and performance
information identified in special
controls (3)(iii) and (3)(iv).
Certain design verification and
validation identified in special
control (3), including
documentation of certain analytical
studies and clinical studies and
device descriptions.
Failure to correctly interpret Certain labeling information
test results leading to identified in special control (2),
misdiagnosis and associated risk including limitations, warnings,
of false test results. device descriptions, explanation of
procedures, and performance
information identified in special
controls (3)(iii) and (3)(iv).
Certain design verification and
validation identified in special
control (3), including
documentation of certain analytical
studies and clinical studies and
device descriptions.
Failure to correctly operate the Use of certain specimen collection
device leading to false test devices identified in special
results or incorrect control (1).
interpretation of test results. Certain labeling information
identified in special control (2),
including limitations, warnings,
device descriptions, explanation of
procedures, and performance
information identified in special
controls (3)(iii) and (3)(iv).
Certain design verification and
validation identified in special
control (3), including
documentation of certain analytical
studies and clinical studies and
device descriptions.
------------------------------------------------------------------------
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 detect and
identify microorganism nucleic acids and resistance markers from
patients with suspected orthopedic infection. 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.
[[Page 25785]]
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. 866.3988 to subpart D to read as follows:
Sec. 866.3988 Device to detect and identify microorganism nucleic
acids and resistance markers from patients with suspected orthopedic
infection.
(a) Identification. A device to detect and identify microorganism
nucleic acids and resistance markers from patients with suspected
orthopedic infection is a qualitative in vitro device intended to
simultaneously detect and identify microorganism nucleic acids from
human clinical specimens collected from patients with suspected
orthopedic infection. The device detects specific nucleic acid
sequences for microorganism identification as well as markers for
antimicrobial resistance. This device is intended to aid in the
diagnosis of orthopedic infections when used in conjunction with other
clinical signs and symptoms and other laboratory findings. However, the
device does not replace traditional methods for culture and
susceptibility testing.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) 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.
(2) The labeling required under Sec. 809.10(b) of this chapter
must include:
(i) An intended use that includes a detailed description of targets
the device detects and measures, the results provided to the user, the
clinical indications appropriate for test use, and the specific
population(s) for which the device is intended.
(ii) Limiting statements, when applicable, indicating:
(A) The device is intended to be used in conjunction with clinical
history, signs and symptoms, and results of other diagnostic tests,
including culture and antimicrobial susceptibility testing;
(B) Detection of resistance markers cannot be definitively linked
to specific microorganisms and that the source of a detected resistance
marker may be an organism not detected by the assay; and
(C) Antimicrobial resistance can occur via multiple mechanisms. A
not detected result for the antimicrobial resistance gene assays does
not indicate antimicrobial susceptibility. Culturing and susceptibility
testing of isolates is needed to determine antimicrobial
susceptibility.
(iii) 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.
(iv) Detailed descriptions of the performance characteristics of
the device for all claimed specimen types as shown by the analytical
and clinical studies required under paragraphs (b)(3)(iii) and
(b)(3)(iv) of this section except specimen stability performance
characteristics.
(3) Design verification and validation must include:
(i) A detailed device description, including all device parts,
control elements incorporated into the test procedure, reagents
required but not provided, the principle of device operation and test
methodology, and the computational path from collected raw data to
reported result (e.g., how collected raw signals are converted into a
reported result).
(ii) A detailed description of the impact of any software,
including software applications and hardware-based devices that
incorporate software, on the device's functions.
(iii) Detailed documentation of analytical studies, including those
demonstrating Limit of Detection, inclusivity, cross-reactivity,
microbial interference, interfering substances, competitive inhibition,
carryover/cross contamination, specimen stability, within lab
precision, and reproducibility, as appropriate.
(iv) Detailed documentation and performance results from a clinical
study that includes prospective (sequentially collected) 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 using
a comparator method that FDA has determined to be appropriate. Detailed
documentation must include the clinical study protocol (including a
predefined statistical analysis plan), study report, testing results,
and results of all statistical analyses.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-09335 Filed 5-11-26; 8:45 am]
BILLING CODE 4164-01-P
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