Medical Devices; General Hospital and Personal Use Devices; Classification of the Ultraviolet Radiation Chamber Disinfection Device, 72587-72589 [2015-29660]
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Federal Register / Vol. 80, No. 224 / Friday, November 20, 2015 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 880
[Docket No. FDA–2015–N–3838]
Medical Devices; General Hospital and
Personal Use Devices; Classification
of the Ultraviolet Radiation Chamber
Disinfection Device
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or the Agency) is
classifying the ultraviolet (UV) radiation
chamber disinfection device into class II
(special controls). The special controls
that will apply to the device are
identified in this order and will be part
of the codified language for the UV
radiation chamber disinfection device
classification. The Agency is classifying
the device into class II (special controls)
in order to provide a reasonable
assurance of safety and effectiveness of
the device.
DATES: This order is effective November
20, 2015. The classification was
applicable on December 20, 2011.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Claverie, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2508, Silver Spring,
MD 20993–0002, 301–796–6298.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
tkelley on DSK3SPTVN1PROD with RULES
In accordance with section 513(f)(1) of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C.
360c(f)(1)), devices that were not in
commercial distribution before May 28,
1976 (the date of enactment of the
Medical Device Amendments of 1976),
generally referred to as postamendments
devices, are classified automatically by
statute into class III without any FDA
rulemaking process. These devices
remain in class III and require
premarket approval, unless and until
the device is classified or reclassified
into class I or II, or FDA issues an order
finding the device to be substantially
equivalent, in accordance with section
513(i) of the FD& C Act, to a predicate
device that does not require premarket
approval. The Agency determines
whether new devices are substantially
equivalent to predicate devices by
means of premarket notification
procedures in section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part
807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, as
amended by section 607 of the Food and
Drug Administration Safety and
Innovation Act (Pub. L. 112–144),
provides two procedures by which a
person may request FDA to classify a
device under the criteria set forth in
section 513(a)(1) of the FD&C Act.
Under the first procedure, the person
submits a premarket notification under
section 510(k) of the FD&C Act for a
device that has not previously been
classified and, within 30 days of
receiving an order classifying the device
into class III under section 513(f)(1) of
the FD&C Act, the person requests a
classification under section 513(f)(2) .
Under the second procedure, rather than
first submitting a premarket notification
under section 510(k) of the FD&C Act
and then a request for classification
under the first procedure, the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence and requests a classification
under section 513(f)(2) of the FD&C Act.
If the person submits a request to
classify the device under this second
procedure, FDA may decline to
undertake the classification request if
FDA identifies a legally marketed device
that could provide a reasonable basis for
review of substantial equivalence with
the device or if FDA determines that the
device submitted is not of ‘‘lowmoderate risk’’ or that general controls
would be inadequate to control the risks
and special controls to mitigate the risks
cannot be developed.
In response to a request to classify a
device under either procedure provided
by section 513(f)(2) of the FD&C Act,
FDA will classify the device by written
order within 120 days. This
classification will be the initial
classification of the device. In
accordance with section 513(f)(1) of the
FD&C Act, FDA issued an order on
October 28, 2010, classifying the
Vioguard Self-Sanitizing Keyboard into
class III, because it was not substantially
equivalent to a device that was
introduced or delivered for introduction
into interstate commerce for commercial
distribution before May 28, 1976, or a
device which was subsequently
reclassified into class I or class II. On
November 2, 2010, Vioguard submitted
a request for classification of the
Vioguard Self-Sanitizing Keyboard
under section 513(f)(2) of the FD&C Act.
The manufacturer recommended that
the device be classified into class II (Ref.
1).
In accordance with section 513(f)(2) of
the FD&C Act, 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. FDA classifies 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 to provide
reasonable assurance of the safety and
effectiveness of the device for its
intended use. After review of the
information submitted in the request,
FDA determined that the device can be
classified into class II with the
establishment of special controls. FDA
believes these special controls will
provide reasonable assurance of the
safety and effectiveness of the device.
Therefore, on December 20, 2011,
FDA issued an order to the requestor
classifying the device into class II. FDA
is codifying the classification of the
device by adding 21 CFR 880.6600.
Following the effective date of this
final classification order, any firm
submitting a premarket notification
(510(k)) for a UV radiation chamber
disinfection device will need to comply
with the special controls named in this
final order. The device is assigned the
generic name UV radiation chamber
disinfection device, and it is identified
as a UV chamber disinfection device
intended for the low-level surface
disinfection of non-porous equipment
surfaces by dose-controlled UV
irradiation. This classification does not
include self-contained open chamber
UV disinfection devices intended for
whole room disinfection in a health care
environment.
FDA has identified the following risks
to health associated specifically with
this type of device, as well as the
mitigation measures required to mitigate
these risks in table 1.
TABLE 1—ULTRAVIOLET RADIATION CHAMBER DISINFECTION DEVICE RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measures
Inadequate Equipment Disinfection ..........................................................
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Performance Testing.
Labeling.
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Federal Register / Vol. 80, No. 224 / Friday, November 20, 2015 / Rules and Regulations
TABLE 1—ULTRAVIOLET RADIATION CHAMBER DISINFECTION DEVICE RISKS AND MITIGATION MEASURES—Continued
Identified risks
Mitigation measures
UV Radiation Exposure ............................................................................
Electrical Shock ........................................................................................
Electromagnetic Interference ....................................................................
Ozone Exposure .......................................................................................
Processed Equipment Incompatibility ......................................................
Contamination of Device ..........................................................................
Software Malfunction ................................................................................
FDA believes that the special controls
in § 880.6600(b)(1) through (4), in
addition to the general controls, address
these risks to health and provide
reasonable assurance of the safety and
effectiveness.
Section 510(m) of the FD&C Act
provides that FDA may exempt a class
II device from the premarket notification
requirements under section 510(k) of the
FD&C Act, if FDA determines that
premarket notification is not necessary
to provide reasonable assurance of the
safety and effectiveness of the device.
For this type of device, FDA has
determined that premarket notification
is necessary to provide reasonable
assurance of the safety and effectiveness
of the device. Therefore, this device
type is not exempt from premarket
notification requirements. Persons who
intend to market this type of device
must submit to FDA a premarket
notification, prior to marketing the
device, which contains information
about the UV radiation chamber
disinfection device they intend to
market.
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II. Environmental Impact
We have 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.
III. 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–
3520). The collections of information in
part 807, subpart E, regarding premarket
notification submissions have been
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Performance Testing.
Labeling.
Electrical Safety Testing.
Electromagnetic Compatibility (EMC) Testing.
Labeling.
Ozone Generation Limits.
Labeling.
Performance Testing.
Labeling.
Cleaning and Disinfection Validation.
Labeling.
Hazard Analysis of Software.
Software Verification and Validation.
approved under OMB control number
0910–0120, and the collections of
information in 21 CFR part 801,
regarding labeling have been approved
under OMB control number 0910–0485.
IV. Reference
The following reference is on display
in the Division of Dockets Management
(see ADDRESSES) and is available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; it is also available electronically
at https://www.regulations.gov.
1. DEN100013: de novo request per
513(f)(2) from Vioguard, dated November 2,
2010.
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
1. The authority citation for 21 CFR
part 880 continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
2. Section 880.6600 is added to
subpart G to read as follows:
■
§ 880.6600 Ultraviolet (UV) radiation
chamber disinfection device.
(a) Identification. An ultraviolet (UV)
radiation chamber disinfection device is
intended for the low-level surface
disinfection of non-porous equipment
surfaces by dose-controlled UV
irradiation. This classification does not
include self-contained open chamber
UV radiation disinfection devices
intended for whole room disinfection in
a health care environment.
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(b) Classification—Class II (special
controls). The special controls for this
device are:
(1) Performance testing must
demonstrate the following:
(i) The chamber’s ability to control the
UV radiation dose during operation.
(ii) The chamber’s disinfection
performance through microbial
challenge testing.
(iii) Evidence that the equipment
intended to be processed is UV
compatible.
(iv) Validation of the cleaning and
disinfection procedures.
(v) The ability of the device to
continue to perform to all specification
after cleaning and disinfection.
(vi) Whether the device generates
ozone (if so, 21 CFR 801.415, Maximum
acceptable level of ozone, applies).
(2) Appropriate software verification,
validation, and hazard analysis must be
performed.
(3) Appropriate analysis and/or
testing must validate electrical safety,
mechanical safety, and electromagnetic
compatibility of the device in its
intended use environment.
(4) The labeling must include:
(i) UV hazard warning labels.
(ii) Explanation of all displays and/or
labeling on user interface.
(iii) Explanation of device safety
interlocks.
(iv) Explanation of all disinfection
cycle signals, cautions and warnings.
(v) Device operating procedures.
(vi) Identification of the expected UV
lamp operational life and instructions
for procedures on replacement of the
UV lamp when needed.
(vii) Procedures to follow in case of
UV lamp malfunction or failure.
(viii) Procedures for disposing of
mercury-containing UV lamps, if
applicable.
(ix) Identification of specific
equipment that is compatible with the
UV radiation dose generated by the
device and that can safely undergo UV
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Federal Register / Vol. 80, No. 224 / Friday, November 20, 2015 / Rules and Regulations
radiation low-level disinfection in the
chamber device.
(x) Description of the required
preparation of equipment for
disinfection in the UV radiation
chamber device.
(xi) Identification of the specific
microbes used in successful
performance testing of the device.
(xii) Validated instructions for
cleaning and disinfection of the device.
Dated: November 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–29660 Filed 11–19–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 890
[Docket No. FDA–2015–P–1197]
Medical Devices; Exemption From
Premarket Notification; Class II
Devices; Electric Positioning Chair
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or the Agency) is
publishing an order granting a petition
requesting exemption from premarket
notification requirements for electric
positioning chair devices. An electric
positioning chair is a device with a
motorized positioning control that is
intended for medical purposes and that
can be adjusted to various positions.
These devices are used to provide
stability for patients with athetosis
(involuntary spasms) and to alter
postural positions. This order exempts
electric positioning chairs, class II
devices, from premarket notification,
subject to certain conditions for
exemption. This exemption from
premarket notification, subject to these
conditions (and the limitations in the
physical medicine devices limitations of
exemptions from premarket notification
section of the device regulations), is
immediately in effect for electric
positioning chairs. FDA is publishing
this order in accordance with the
exemption from class II premarket
notification section of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act).
DATES: This order is effective November
20, 2015.
FOR FURTHER INFORMATION CONTACT: John
Marszalek, Center for Devices and
Radiological Health, Food and Drug
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SUMMARY:
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Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1427, Silver Spring,
MD 20993, 301–796–7067.
SUPPLEMENTARY INFORMATION:
I. Statutory Background
Section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and its implementing
regulations (21 CFR part 807) require
persons who propose to begin the
introduction or delivery for introduction
into interstate commerce for commercial
distribution of a device intended for
human use to submit a premarket
notification (510(k)) to FDA. The device
may not be marketed until FDA finds it
‘‘substantially equivalent’’ within the
meaning of section 513(i) of the FD&C
Act (21 U.S.C. 360c(i)) to a legally
marketed device that does not require
premarket approval.
On November 21, 1997, the President
signed into law the Food and Drug
Administration Modernization Act of
1997 (FDAMA). Section 206 of FDAMA
added section 510(m) to the FD&C Act.
Section 510(m)(1) of the FD&C Act
requires FDA, within 60 days after
enactment of FDAMA, to publish in the
Federal Register a list of each type of
class II device that does not require a
report under section 510(k) of the FD&C
Act to provide reasonable assurance of
safety and effectiveness. Section 510(m)
of the FD&C Act further provides that a
510(k) will no longer be required for
these devices upon the date of
publication of the list in the Federal
Register. FDA published that list in the
Federal Register of January 21, 1998 (63
FR 3142).
Section 510(m)(2) of the FD&C Act
provides that FDA may exempt a device
from premarket notification
requirements on its own initiative, or
upon petition of an interested person, if
FDA determines that a 510(k) is not
necessary to assure the safety and
effectiveness of the device. This section
requires FDA to publish in the Federal
Register a notice of intent to exempt a
device, or of the petition, and to provide
a 30-day comment period. FDA must
publish in the Federal Register its final
determination regarding the exemption
of the device that was the subject of the
notice. If FDA fails to respond to a
petition under this section within 180
days of receiving it, the petition shall be
deemed granted.
II. Criteria for Exemption
There are a number of factors FDA
may consider to determine whether a
510(k) is necessary to assure the safety
and effectiveness of a class II device.
These factors are discussed in the
guidance that the Agency issued on
February 19, 1998, entitled ‘‘Procedures
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72589
for Class II Device Exemptions From
Premarket Notification, Guidance for
Industry and CDRH Staff’’ (Class II
510(k) Exemption Guidance). That
guidance can be obtained through the
Internet on the Center for Devices and
Radiological Health home page at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/ucm080198.htm or
by sending an email request to CDRHGuidance@fda.hhs.gov to receive a copy
of the document. Please use the
document number 159 to identify the
guidance you are requesting.
III. Device Description
Electric positioning chairs are devices
with a motorized positioning control
that are intended for medical purposes
and that can be adjusted to various
positions. Existing legally marketed
devices have identified a range of
specific procedures or conditions for
which an electric positioning chair
could be used to provide stability and
to alter postural positions (e.g.,
muscular dystrophy, Parkinson’s
syndrome, or joint replacements). The
devices are primarily intended to
provide stability and a controlled lift
from a seated position to a standing
position, while supporting the patient’s
weight (alter postural positions). The
device consists of a frame (where the
user would sit) and a lift mechanism,
and may also allow the patient to
recline in the device.
IV. Petition
On April 10, 2015, FDA received a
petition requesting an exemption from
premarket notification for electric
positioning chair devices. (See Docket
No. FDA–2015–P–1197.) These devices
are currently classified under 21 CFR
890.3110 Electric positioning chair.
In the Federal Register of June 12,
2015 (80 FR 33525), FDA published a
notice announcing that this petition had
been received and provided opportunity
for interested persons to submit
comments on the petition by July 13,
2015. FDA received no comments.
FDA has assessed the need for 510(k)
clearance for this type of device using
the criteria laid out in the Class II 510(k)
Exemption Guidance and in the January
21, 1998, notice (63 FR 3142 at 3143).
Based on its review, FDA believes that
premarket notification is not necessary
to assure the safety and effectiveness of
the device, as long as certain conditions
are met. FDA believes that the risks
posed by the device (such as instability,
entrapment, use error, falls and
associated injuries, battery/electrical/
mechanical failure, pressure sores,
bruising, burns, electric shock, and
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]]>Agencies
[Federal Register Volume 80, Number 224 (Friday, November 20, 2015)]
[Rules and Regulations]
[Pages 72587-72589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29660]
[[Page 72587]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 880
[Docket No. FDA-2015-N-3838]
Medical Devices; General Hospital and Personal Use Devices;
Classification of the Ultraviolet Radiation Chamber Disinfection Device
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
classifying the ultraviolet (UV) radiation chamber disinfection device
into class II (special controls). The special controls that will apply
to the device are identified in this order and will be part of the
codified language for the UV radiation chamber disinfection device
classification. The Agency is classifying the device into class II
(special controls) in order to provide a reasonable assurance of safety
and effectiveness of the device.
DATES: This order is effective November 20, 2015. The classification
was applicable on December 20, 2011.
FOR FURTHER INFORMATION CONTACT: Elizabeth Claverie, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2508, Silver Spring, MD 20993-0002, 301-
796-6298.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD& C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1) of
the FD&C Act. Under the first procedure, the person submits a premarket
notification under section 510(k) of the FD&C Act for a device that has
not previously been classified and, within 30 days of receiving an
order classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person requests a classification under section
513(f)(2) . Under the second procedure, rather than first submitting a
premarket notification under section 510(k) of the FD&C Act and then a
request for classification under the first procedure, the person
determines that there is no legally marketed device upon which to base
a determination of substantial equivalence and requests a
classification under section 513(f)(2) of the FD&C Act. If the person
submits a request to classify the device under this second procedure,
FDA may decline to undertake the classification request if FDA
identifies a legally marketed device that could provide a reasonable
basis for review of substantial equivalence with the device or if FDA
determines that the device submitted is not of ``low-moderate risk'' or
that general controls would be inadequate to control the risks and
special controls to mitigate the risks cannot be developed.
In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device. In
accordance with section 513(f)(1) of the FD&C Act, FDA issued an order
on October 28, 2010, classifying the Vioguard Self-Sanitizing Keyboard
into class III, because it was not substantially equivalent to a device
that was introduced or delivered for introduction into interstate
commerce for commercial distribution before May 28, 1976, or a device
which was subsequently reclassified into class I or class II. On
November 2, 2010, Vioguard submitted a request for classification of
the Vioguard Self-Sanitizing Keyboard under section 513(f)(2) of the
FD&C Act. The manufacturer recommended that the device be classified
into class II (Ref. 1).
In accordance with section 513(f)(2) of the FD&C Act, 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. FDA
classifies 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 to provide reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the request, FDA determined that the device
can be classified into class II with the establishment of special
controls. FDA believes these special controls will provide reasonable
assurance of the safety and effectiveness of the device.
Therefore, on December 20, 2011, FDA issued an order to the
requestor classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 880.6600.
Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for a UV
radiation chamber disinfection device will need to comply with the
special controls named in this final order. The device is assigned the
generic name UV radiation chamber disinfection device, and it is
identified as a UV chamber disinfection device intended for the low-
level surface disinfection of non-porous equipment surfaces by dose-
controlled UV irradiation. This classification does not include self-
contained open chamber UV disinfection devices intended for whole room
disinfection in a health care environment.
FDA has identified the following risks to health associated
specifically with this type of device, as well as the mitigation
measures required to mitigate these risks in table 1.
Table 1--Ultraviolet Radiation Chamber Disinfection Device Risks and
Mitigation Measures
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
Inadequate Equipment Disinfection...... Performance Testing.
Labeling.
[[Page 72588]]
UV Radiation Exposure.................. Performance Testing.
Labeling.
Electrical Shock....................... Electrical Safety Testing.
Electromagnetic Interference........... Electromagnetic Compatibility
(EMC) Testing.
Labeling.
Ozone Exposure......................... Ozone Generation Limits.
Labeling.
Processed Equipment Incompatibility.... Performance Testing.
Labeling.
Contamination of Device................ Cleaning and Disinfection
Validation.
Labeling.
Software Malfunction................... Hazard Analysis of Software.
Software Verification and
Validation.
------------------------------------------------------------------------
FDA believes that the special controls in Sec. 880.6600(b)(1)
through (4), in addition to the general controls, address these risks
to health and provide reasonable assurance of the safety and
effectiveness.
Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act, if FDA determines that premarket notification
is not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification, prior to marketing the device,
which contains information about the UV radiation chamber disinfection
device they intend to market.
II. Environmental Impact
We have 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.
III. 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. 3501-3520). The collections of information in
part 807, subpart E, regarding premarket notification submissions have
been approved under OMB control number 0910-0120, and the collections
of information in 21 CFR part 801, regarding labeling have been
approved under OMB control number 0910-0485.
IV. Reference
The following reference is on display in the Division of Dockets
Management (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov.
1. DEN100013: de novo request per 513(f)(2) from Vioguard, dated
November 2, 2010.
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 21 CFR part 880 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Section 880.6600 is added to subpart G to read as follows:
Sec. 880.6600 Ultraviolet (UV) radiation chamber disinfection device.
(a) Identification. An ultraviolet (UV) radiation chamber
disinfection device is intended for the low-level surface disinfection
of non-porous equipment surfaces by dose-controlled UV irradiation.
This classification does not include self-contained open chamber UV
radiation disinfection devices intended for whole room disinfection in
a health care environment.
(b) Classification--Class II (special controls). The special
controls for this device are:
(1) Performance testing must demonstrate the following:
(i) The chamber's ability to control the UV radiation dose during
operation.
(ii) The chamber's disinfection performance through microbial
challenge testing.
(iii) Evidence that the equipment intended to be processed is UV
compatible.
(iv) Validation of the cleaning and disinfection procedures.
(v) The ability of the device to continue to perform to all
specification after cleaning and disinfection.
(vi) Whether the device generates ozone (if so, 21 CFR 801.415,
Maximum acceptable level of ozone, applies).
(2) Appropriate software verification, validation, and hazard
analysis must be performed.
(3) Appropriate analysis and/or testing must validate electrical
safety, mechanical safety, and electromagnetic compatibility of the
device in its intended use environment.
(4) The labeling must include:
(i) UV hazard warning labels.
(ii) Explanation of all displays and/or labeling on user interface.
(iii) Explanation of device safety interlocks.
(iv) Explanation of all disinfection cycle signals, cautions and
warnings.
(v) Device operating procedures.
(vi) Identification of the expected UV lamp operational life and
instructions for procedures on replacement of the UV lamp when needed.
(vii) Procedures to follow in case of UV lamp malfunction or
failure.
(viii) Procedures for disposing of mercury-containing UV lamps, if
applicable.
(ix) Identification of specific equipment that is compatible with
the UV radiation dose generated by the device and that can safely
undergo UV
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radiation low-level disinfection in the chamber device.
(x) Description of the required preparation of equipment for
disinfection in the UV radiation chamber device.
(xi) Identification of the specific microbes used in successful
performance testing of the device.
(xii) Validated instructions for cleaning and disinfection of the
device.
Dated: November 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29660 Filed 11-19-15; 8:45 am]
BILLING CODE 4164-01-P
