Rule2026-18426
Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 10, 2026
Effective
September 10, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is classifying the whole room microbial reduction device 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 whole room microbial reduction device. 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 174 (Thursday, September 10, 2026)</title>
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[Federal Register Volume 91, Number 174 (Thursday, September 10, 2026)]
[Rules and Regulations]
[Pages 57507-57509]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18426]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 880
[Docket No. FDA-2026-N-9909]
Medical Devices; General Hospital and Personal Use Devices;
Classification of the Whole Room Microbial Reduction Device
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
whole room microbial reduction device 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 whole room microbial reduction device. 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 September 10, 2026. The classification
was applicable on September 1, 2023.
FOR FURTHER INFORMATION CONTACT: Christopher Dugard, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4640, Silver Spring, MD 20993-0002, 240-
402-6031, <a href="/cdn-cgi/l/email-protection#094a617b607a7d6679616c7b274d7c6e687b6d496f6d682761617a276e667f"><span class="__cf_email__" data-cfemail="82c1eaf0ebf1f6edf2eae7f0acc6f7e5e3f0e6c2e4e6e3aceaeaf1ace5edf4">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the whole room
microbial reduction device 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 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 February 1, 2023, FDA received Xenex Disinfection Services,
Inc.'s request for De Novo classification of the LightStrike+ device.
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
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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 September 1, 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
880.6510.\1\ We have named the generic type of device ``whole room
microbial reduction device,'' and it is identified as a medical device
to be used to reduce microbial load on medical device surfaces
following cleaning and disinfection.
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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 Whole Room
Microbial Reduction Devices
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Identified Risks to Health Mitigation Measures
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Exposure to microbiocidal agent, Non-clinical performance
leading to skin and eye damage. testing; biocompatibility
evaluation; software
verification, validation, and
hazard analysis; and labeling.
Respiratory mucous membrane irritation Non-clinical performance
and pulmonary edema due to chemical testing; and biocompatibility
exposure. evaluation.
Patient cross-contamination due to Non-clinical performance
device failure leading to inadequate testing; labeling; and
microbial reduction. software verification,
validation, and hazard
analysis.
Electrical shock....................... Electrical safety testing; non-
clinical performance testing;
and labeling.
Interference with other devices........ Electromagnetic compatibility
testing; electrical safety
testing; and labeling.
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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 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.
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 whole room microbial
reduction devices. 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 part 801 regarding labeling have been approved under OMB control
number 0910-0485.
List of Subjects in 21 CFR Part 880
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
880 is amended as follows:
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
0
1. The authority citation for part 880 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 880.6510 to subpart G to read as follows:
Sec. 880.6510 Whole room microbial reduction device.
(a) Identification. A whole room microbial reduction device is a
medical device to be used to reduce microbial load on medical device
surfaces following cleaning and disinfection.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be tested:
(i) Performance testing must demonstrate microbial log reduction of
the demonstrated most resistant microorganism on medical device
surfaces commensurate with the intended level of microbial reduction;
(ii) Simulated use testing must evaluate device performance under
simulated worst-case use conditions
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(e.g., soiling, room objects and surfaces, distances);
(iii) In-use testing must evaluate device performance under real-
world use conditions;
(iv) Performance testing must demonstrate the photobiological
safety of any lamps or lamp systems;
(v) Performance testing must evaluate safety features intended to
prevent exposure and ensure that device operation can only occur in an
unoccupied environment; and
(vi) Performance testing must characterize the long-term material
compatibility of the microbiocidal agent on clinically relevant
surfaces and/or devices.
(2) Biocompatibility testing must demonstrate safe residual levels
of chemicals on medical devices surfaces and/or gaseous byproducts in
air.
(3) Software verification, validation, and hazard analysis must be
performed for any software components.
(4) Performance data must demonstrate the electromagnetic
compatibility and electrical safety of the device.
(5) Labeling must include:
(i) Warnings and instructions to ensure the device is operated in
an unoccupied environment;
(ii) Setup and positioning instructions; and
(iii) Information regarding material compatibility.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-18426 Filed 9-9-26; 8:45 am]
BILLING CODE 4164-01-P
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