Rule2025-10787
Medical Devices; Immunology and Microbiology Devices; Classification of the Cellular Analysis System for Multiplexed Antimicrobial Susceptibility Testing
Primary source
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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, the Agency, or we) is classifying the cellular analysis system for multiplexed antimicrobial susceptibility testing 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 cellular analysis system for multiplexed antimicrobial susceptibility testing'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 113 (Friday, June 13, 2025)</title>
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[Federal Register Volume 90, Number 113 (Friday, June 13, 2025)]
[Rules and Regulations]
[Pages 24962-24964]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10787]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2025-N-1503]
Medical Devices; Immunology and Microbiology Devices;
Classification of the Cellular Analysis System for Multiplexed
Antimicrobial Susceptibility Testing
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 cellular analysis system for multiplexed antimicrobial
susceptibility testing 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 cellular analysis system
for multiplexed antimicrobial susceptibility testing'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 June 13, 2025. The classification was
applicable on February 23, 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#e8ba918986c6a49d8a8d9a9ca88e8c89c680809bc68f879e"><span class="__cf_email__" data-cfemail="73210a121d5d3f0611160107331517125d1b1b005d141c05">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the cellular analysis system for
multiplexed antimicrobial susceptibility testing 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 to a predicate device that does not require
premarket approval (see 21 U.S.C. 360c(i)). 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 (21 U.S.C. 360c(a)(1)). 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 July 14, 2016, FDA received Accelerate Diagnostics, Inc.'s
request for De Novo classification of the Accelerate PhenoTest BC Kit.
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 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 February 23, 2017, 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
[[Page 24963]]
CFR 866.1650.\1\ We have named the generic type of device a cellular
analysis system for multiplexed antimicrobial susceptibility testing,
and it is identified as a multiplex qualitative and/or quantitative in
vitro diagnostic device intended for the identification and
determination of the antimicrobial susceptibility results of organisms
detected in samples from patients with suspected microbial infections.
This device is intended to aid in the determination of antimicrobial
susceptibility or resistance when used in conjunction with 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--A Cellular Analysis System for Multiplexed Antimicrobial
Susceptibility Testing Risks to Health and Required Mitigations
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Identified risks to health Mitigation measures
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If identification assay is included, false Special controls (1)
positive or false negative results or incorrect and (2)(i).
identifications can lead to:
<bullet> a delay in determining the true
cause of the infection;
<bullet> unnecessary, ineffective, or lack
of antimicrobial therapy;
<bullet> delayed or skipped treatments or
diagnostic procedures;
<bullet> inappropriate infection prevention
and control measures and/or public health
procedures;
<bullet> interference with antimicrobial
stewardship efforts.
Failure to perform appropriate antimicrobial
susceptibility testing may result in:
<bullet> unnecessary, ineffective or lack of
antimicrobial therapy;
<bullet> interference with antimicrobial
stewardship efforts;
<bullet> development of antimicrobial
resistance.
An organism determined to be resistant when it
is susceptible may lead to:
<bullet> treatment with an ineffective
antibiotic;
<bullet> administration of unnecessary broad-
spectrum drugs;
<bullet> side effects from potent
antimicrobials;
<bullet> implementation of infection control
measures.
An organism determined to be susceptible when it
is resistant may lead to:
<bullet> treatment with an ineffective
antibiotic;
<bullet> increased morbidity or death.
Errors in interpretation........................ Special control
(2)(ii).
Failure to correctly operate the test system.... Special control
(2)(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 final 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. 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 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 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. 866.1650 to subpart B to read as follows:
Sec. 866.1650 A cellular analysis system for multiplexed
antimicrobial susceptibility testing.
(a) Identification. A cellular analysis system for multiplexed
antimicrobial susceptibility testing is a multiplex qualitative and/or
quantitative in vitro diagnostic device intended for the identification
and determination of the antimicrobial susceptibility results of
organisms detected in samples from patients with suspected microbial
infections. This device is intended to aid in the determination of
antimicrobial susceptibility or resistance when used in conjunction
with other laboratory findings.
[[Page 24964]]
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Design verification and validation must include:
(i) Detailed device description documentation, including the device
components, ancillary reagents required but not provided, a detailed
explanation of the methodology, including primer/probe sequence,
design, rationale for sequence selection, and details of the
antimicrobial agents, as applicable.
(ii) Detailed documentation from the following analytical and
clinical performance studies: limit of detection, inclusivity,
precision, reproducibility, interference, cross-reactivity, carryover,
and cross-contamination, quality control and additional studies, as
applicable to specimen type and assay intended use.
(iii) Detailed documentation from an appropriate clinical study.
The study, performed on a study population consistent with the intended
use population, must compare the device performance to results obtained
from well-accepted reference 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) Limitations and protocols regarding the need for correlation of
results by standard laboratory procedures, as applicable.
(ii) A detailed explanation of the interpretation of results and
acceptance criteria.
(iii) A detailed explanation of the principles of operation and
procedures for assay performance and troubleshooting.
Dated: June 9, 2025.
Grace R. Graham
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-10787 Filed 6-12-25; 8:45 am]
BILLING CODE 4164-01-P
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