Rule2026-10908
Medical Devices; General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container With Electronic Monitoring
Primary source
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Published
June 1, 2026
Effective
June 1, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is classifying the rigid sterilization container with electronic monitoring 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 rigid sterilization container with electronic monitoring. 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 104 (Monday, June 1, 2026)</title>
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[Federal Register Volume 91, Number 104 (Monday, June 1, 2026)]
[Rules and Regulations]
[Pages 32349-32351]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10908]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 880
[Docket No. FDA-2026-N-5199]
Medical Devices; General Hospital and Personal Use Devices;
Classification of the Rigid Sterilization Container With Electronic
Monitoring
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
rigid sterilization container with electronic monitoring 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 rigid sterilization container with electronic
monitoring. 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 June 1, 2026. The classification was
applicable on June 17, 2022.
FOR FURTHER INFORMATION CONTACT: Christopher Dugard, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4618, Silver Spring, MD 20993-0002, 240-
402-6031, <a href="/cdn-cgi/l/email-protection#06456e746f757269766e63742842736167746246606267286e6e7528616970"><span class="__cf_email__" data-cfemail="efac879d869c9b809f878a9dc1ab9a888e9d8baf898b8ec187879cc1888099">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA (the Agency or we) has classified the rigid
sterilization container with electronic monitoring 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
[[Page 32350]]
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 16, 2021, FDA received Zuno Medical, Inc.'s request for
De Novo classification of the Zuno Smart Sterilization Container. 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 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 June 17, 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
880.6855.\1\ We have named the generic type of device ``rigid
sterilization container with electronic monitoring,'' and it is
identified as a device intended to be used to enclose medical devices
that are to be sterilized by a health care provider. It is intended to
allow sterilization of the enclosed medical devices and maintain
sterility of the enclosed devices until used. The device provides
sterility status of the enclosed medical devices via real time
electronic monitoring.
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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 Rigid Sterilization
Containers With Electronic Monitoring
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Identified risks to health Mitigation measures
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Infection resulting from exposure to Sterilization validation;
unsterile instruments due to device Software verification,
failure or failure to properly validation, and hazard
interpret sterile barrier status. analysis; Reprocessing
validation; Non-clinical
performance testing; Labeling;
and Human factors testing.
Delayed or cancelled treatment due to Non-clinical performance
device failure. testing.
Adverse tissue reaction................ Biocompatibility evaluation.
Electric shock to user................. Electrical safety testing;
Electromagnetic compatibility
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 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 rigid sterilization
containers with electronic monitoring. 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
[[Page 32351]]
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. 880.6855 to subpart G to read as follows:
Sec. 880.6855 Rigid sterilization container with electronic
monitoring.
(a) Identification. A rigid sterilization container with electronic
monitoring is a device intended to be used to enclose medical devices
that are to be sterilized by a health care provider. It is intended to
allow sterilization of the enclosed medical devices and maintain
sterility of the enclosed devices until used. The device provides
sterility status of the enclosed medical devices via real time
electronic monitoring.
(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 evaluated to ensure
device function and integrity during challenging use:
(i) Vent-to-volume testing must demonstrate adequate sterilant
penetration.
(ii) Sterilization validation must demonstrate that the contents to
be sterilized can adequately achieve the proposed Sterility Assurance
Level (SAL).
(iii) Performance testing must demonstrate the device accurately
informs the end-user of the sterile status of the contents.
(iv) Performance testing must demonstrate the device can maintain
sterility of the enclosed medical products for a minimum 30-day storage
period.
(v) Battery performance and shelf life testing must demonstrate the
device maintains its function throughout its total use-life.
(vi) Battery performance and shelf life testing must demonstrate
the device maintains its function during storage, throughout a minimum
30-day sterile storage period.
(vii) Moisture/sterilant ingress testing must support that the
electronic components are adequately sealed and do not allow moisture/
sterilant ingress.
(viii) Microbial barrier testing must support that the seals,
gaskets, valves, etc. provide an adequate barrier to microbial ingress.
(ix) Seal integrity testing must demonstrate that an adequate seal
is created and maintained throughout the sterile storage period.
(x) Mechanical functionality testing must demonstrate proper
function of any valves, gaskets, or other components essential to the
function of the device.
(xi) For devices with handles, handle strength testing must
demonstrate the handles can withstand the maximum indicated load
weight.
(xii) Corrosion resistance testing must demonstrate adequate
function of any components susceptible to corrosion following the most
challenging use.
(xiii) Dryness evaluation testing must demonstrate the contents to
be sterilized are dry prior to storage.
(xiv) Simulated use testing must evaluate device performance
(including maintenance of sterility and accurate sterility status
monitoring) under real-world worst-case use conditions.
(2) Device components that may contact medical products must be
demonstrated to be biocompatible.
(3) Performance data must validate the reprocessing instructions
for the reusable components of the device.
(4) Software verification, validation, and hazard analysis must be
performed.
(5) Human factors testing must be performed to demonstrate that end
user(s) can safely and correctly use the device, based solely on the
directions for use.
(6) Performance data must demonstrate the electromagnetic
compatibility and electrical safety of the device.
(7) Labeling must include:
(i) Warnings, cautions, and limitations for safe use of the device
including:
(A) A precaution that the lids/trays and any accessories should
only be used with the sterilization container.
(B) A precaution that the use of nonabsorbent tray liners can cause
condensate to pool.
(ii) Device operating procedures including:
(A) Instructions for closures, gaskets, type, sizes, and valve
assembly weight as appropriate.
(B) Instructions for density and distribution of contents, stacking
patterns, or any other recommendations pertaining to load configuration
of the medical devices to be sterilized.
(iii) A description of the validated length of time sterility can
be maintained.
(iv) Identification of any replaceable components, information
about the expected life of these components, and instructions for
procedures on replacement when needed.
(v) Identification of products intended for sterilization that are
compatible for use with the device.
(vi) Description of the required preparation of products intended
for sterilization in the device.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-10908 Filed 5-29-26; 8:45 am]
BILLING CODE 4164-01-P
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