80 FR 72587 - Medical Devices; General Hospital and Personal Use Devices; Classification of the Ultraviolet Radiation Chamber Disinfection Device
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 224 (November 20, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 224 (November 20, 2015)
| Page Range | 72587-72589 | |
| FR Document | 2015-29660 |
[Federal Register Volume 80, Number 224 (Friday, November 20, 2015)] [Rules and Regulations] [Pages 72587-72589] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-29660] [[Page 72587]] ----------------------------------------------------------------------- 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 http://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 [[Page 72589]] 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
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DEPARTMENT OF HEALTH AND device that does not require premarket introduced or delivered for introduction
HUMAN SERVICES approval. The Agency determines into interstate commerce for commercial
whether new devices are substantially distribution before May 28, 1976, or a
Food and Drug Administration equivalent to predicate devices by device which was subsequently
means of premarket notification reclassified into class I or class II. On
21 CFR Part 880 procedures in section 510(k) of the November 2, 2010, Vioguard submitted
[Docket No. FDA–2015–N–3838] FD&C Act (21 U.S.C. 360(k)) and part a request for classification of the
807 (21 CFR part 807) of the regulations. Vioguard Self-Sanitizing Keyboard
Medical Devices; General Hospital and Section 513(f)(2) of the FD&C Act, as under section 513(f)(2) of the FD&C Act.
Personal Use Devices; Classification amended by section 607 of the Food and The manufacturer recommended that
of the Ultraviolet Radiation Chamber Drug Administration Safety and the device be classified into class II (Ref.
Disinfection Device Innovation Act (Pub. L. 112–144), 1).
provides two procedures by which a In accordance with section 513(f)(2) of
AGENCY: Food and Drug Administration, person may request FDA to classify a the FD&C Act, FDA reviewed the
HHS. device under the criteria set forth in request in order to classify the device
ACTION: Final order. section 513(a)(1) of the FD&C Act. under the criteria for classification set
Under the first procedure, the person forth in section 513(a)(1) of the FD&C
SUMMARY: The Food and Drug submits a premarket notification under Act. FDA classifies devices into class II
Administration (FDA or the Agency) is section 510(k) of the FD&C Act for a if general controls by themselves are
classifying the ultraviolet (UV) radiation device that has not previously been insufficient to provide reasonable
chamber disinfection device into class II classified and, within 30 days of assurance of safety and effectiveness,
(special controls). The special controls receiving an order classifying the device but there is sufficient information to
that will apply to the device are into class III under section 513(f)(1) of establish special controls to provide
identified in this order and will be part the FD&C Act, the person requests a reasonable assurance of the safety and
of the codified language for the UV classification under section 513(f)(2) . effectiveness of the device for its
radiation chamber disinfection device Under the second procedure, rather than intended use. After review of the
classification. The Agency is classifying first submitting a premarket notification information submitted in the request,
the device into class II (special controls) under section 510(k) of the FD&C Act FDA determined that the device can be
in order to provide a reasonable and then a request for classification classified into class II with the
assurance of safety and effectiveness of under the first procedure, the person establishment of special controls. FDA
the device. determines that there is no legally believes these special controls will
DATES: This order is effective November marketed device upon which to base a provide reasonable assurance of the
20, 2015. The classification was determination of substantial safety and effectiveness of the device.
applicable on December 20, 2011. equivalence and requests a classification Therefore, on December 20, 2011,
FOR FURTHER INFORMATION CONTACT: under section 513(f)(2) of the FD&C Act. FDA issued an order to the requestor
Elizabeth Claverie, Center for Devices If the person submits a request to classifying the device into class II. FDA
and Radiological Health, Food and Drug classify the device under this second is codifying the classification of the
Administration, 10903 New Hampshire procedure, FDA may decline to device by adding 21 CFR 880.6600.
Ave., Bldg. 66, Rm. 2508, Silver Spring, undertake the classification request if Following the effective date of this
MD 20993–0002, 301–796–6298. FDA identifies a legally marketed device final classification order, any firm
SUPPLEMENTARY INFORMATION: that could provide a reasonable basis for submitting a premarket notification
review of substantial equivalence with (510(k)) for a UV radiation chamber
I. Background the device or if FDA determines that the disinfection device will need to comply
In accordance with section 513(f)(1) of device submitted is not of ‘‘low- with the special controls named in this
the Federal Food, Drug, and Cosmetic moderate risk’’ or that general controls final order. The device is assigned the
Act (the FD&C Act) (21 U.S.C. would be inadequate to control the risks generic name UV radiation chamber
360c(f)(1)), devices that were not in and special controls to mitigate the risks disinfection device, and it is identified
commercial distribution before May 28, cannot be developed. as a UV chamber disinfection device
1976 (the date of enactment of the In response to a request to classify a intended for the low-level surface
Medical Device Amendments of 1976), device under either procedure provided disinfection of non-porous equipment
generally referred to as postamendments by section 513(f)(2) of the FD&C Act, surfaces by dose-controlled UV
devices, are classified automatically by FDA will classify the device by written irradiation. This classification does not
statute into class III without any FDA order within 120 days. This include self-contained open chamber
rulemaking process. These devices classification will be the initial UV disinfection devices intended for
remain in class III and require classification of the device. In whole room disinfection in a health care
premarket approval, unless and until accordance with section 513(f)(1) of the environment.
the device is classified or reclassified FD&C Act, FDA issued an order on FDA has identified the following risks
into class I or II, or FDA issues an order October 28, 2010, classifying the to health associated specifically with
finding the device to be substantially Vioguard Self-Sanitizing Keyboard into this type of device, as well as the
equivalent, in accordance with section class III, because it was not substantially mitigation measures required to mitigate
513(i) of the FD& C Act, to a predicate equivalent to a device that was these risks in table 1.
tkelley on DSK3SPTVN1PROD with RULES
TABLE 1—ULTRAVIOLET RADIATION CHAMBER DISINFECTION DEVICE RISKS AND MITIGATION MEASURES
Identified risks Mitigation measures
Inadequate Equipment Disinfection .......................................................... Performance Testing.
Labeling.
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radiation low-level disinfection in the Administration, 10903 New Hampshire for Class II Device Exemptions From
chamber device. Ave., Bldg. 66, Rm. 1427, Silver Spring, Premarket Notification, Guidance for
(x) Description of the required MD 20993, 301–796–7067. Industry and CDRH Staff’’ (Class II
preparation of equipment for SUPPLEMENTARY INFORMATION: 510(k) Exemption Guidance). That
disinfection in the UV radiation guidance can be obtained through the
chamber device. I. Statutory Background Internet on the Center for Devices and
(xi) Identification of the specific Section 510(k) of the FD&C Act (21 Radiological Health home page at
microbes used in successful U.S.C. 360(k)) and its implementing http://www.fda.gov/MedicalDevices/
performance testing of the device. regulations (21 CFR part 807) require DeviceRegulationandGuidance/
(xii) Validated instructions for persons who propose to begin the GuidanceDocuments/ucm080198.htm or
cleaning and disinfection of the device. introduction or delivery for introduction by sending an email request to CDRH-
Dated: November 17, 2015. into interstate commerce for commercial Guidance@fda.hhs.gov to receive a copy
Leslie Kux,
distribution of a device intended for of the document. Please use the
human use to submit a premarket document number 159 to identify the
Associate Commissioner for Policy.
notification (510(k)) to FDA. The device guidance you are requesting.
[FR Doc. 2015–29660 Filed 11–19–15; 8:45 am] may not be marketed until FDA finds it
III. Device Description
BILLING CODE 4164–01–P ‘‘substantially equivalent’’ within the
meaning of section 513(i) of the FD&C Electric positioning chairs are devices
Act (21 U.S.C. 360c(i)) to a legally with a motorized positioning control
DEPARTMENT OF HEALTH AND marketed device that does not require that are intended for medical purposes
HUMAN SERVICES premarket approval. and that can be adjusted to various
On November 21, 1997, the President positions. Existing legally marketed
Food and Drug Administration devices have identified a range of
signed into law the Food and Drug
Administration Modernization Act of specific procedures or conditions for
21 CFR Part 890 1997 (FDAMA). Section 206 of FDAMA which an electric positioning chair
[Docket No. FDA–2015–P–1197] added section 510(m) to the FD&C Act. could be used to provide stability and
Section 510(m)(1) of the FD&C Act to alter postural positions (e.g.,
Medical Devices; Exemption From requires FDA, within 60 days after muscular dystrophy, Parkinson’s
Premarket Notification; Class II enactment of FDAMA, to publish in the syndrome, or joint replacements). The
Devices; Electric Positioning Chair Federal Register a list of each type of devices are primarily intended to
class II device that does not require a provide stability and a controlled lift
AGENCY: Food and Drug Administration,
report under section 510(k) of the FD&C from a seated position to a standing
HHS.
Act to provide reasonable assurance of position, while supporting the patient’s
ACTION: Final order. safety and effectiveness. Section 510(m) weight (alter postural positions). The
SUMMARY: The Food and Drug of the FD&C Act further provides that a device consists of a frame (where the
Administration (FDA or the Agency) is 510(k) will no longer be required for user would sit) and a lift mechanism,
publishing an order granting a petition these devices upon the date of and may also allow the patient to
requesting exemption from premarket publication of the list in the Federal recline in the device.
notification requirements for electric Register. FDA published that list in the
IV. Petition
positioning chair devices. An electric Federal Register of January 21, 1998 (63
FR 3142). On April 10, 2015, FDA received a
positioning chair is a device with a
Section 510(m)(2) of the FD&C Act petition requesting an exemption from
motorized positioning control that is
provides that FDA may exempt a device premarket notification for electric
intended for medical purposes and that
from premarket notification positioning chair devices. (See Docket
can be adjusted to various positions.
requirements on its own initiative, or No. FDA–2015–P–1197.) These devices
These devices are used to provide
upon petition of an interested person, if are currently classified under 21 CFR
stability for patients with athetosis
FDA determines that a 510(k) is not 890.3110 Electric positioning chair.
(involuntary spasms) and to alter In the Federal Register of June 12,
necessary to assure the safety and
postural positions. This order exempts 2015 (80 FR 33525), FDA published a
effectiveness of the device. This section
electric positioning chairs, class II notice announcing that this petition had
requires FDA to publish in the Federal
devices, from premarket notification, been received and provided opportunity
Register a notice of intent to exempt a
subject to certain conditions for for interested persons to submit
device, or of the petition, and to provide
exemption. This exemption from comments on the petition by July 13,
a 30-day comment period. FDA must
premarket notification, subject to these 2015. FDA received no comments.
publish in the Federal Register its final
conditions (and the limitations in the FDA has assessed the need for 510(k)
determination regarding the exemption
physical medicine devices limitations of clearance for this type of device using
of the device that was the subject of the
exemptions from premarket notification the criteria laid out in the Class II 510(k)
notice. If FDA fails to respond to a
section of the device regulations), is Exemption Guidance and in the January
petition under this section within 180
immediately in effect for electric 21, 1998, notice (63 FR 3142 at 3143).
days of receiving it, the petition shall be
positioning chairs. FDA is publishing Based on its review, FDA believes that
deemed granted.
this order in accordance with the premarket notification is not necessary
exemption from class II premarket II. Criteria for Exemption to assure the safety and effectiveness of
notification section of the Federal Food, There are a number of factors FDA the device, as long as certain conditions
tkelley on DSK3SPTVN1PROD with RULES
Drug, and Cosmetic Act (the FD&C Act). may consider to determine whether a are met. FDA believes that the risks
DATES: This order is effective November 510(k) is necessary to assure the safety posed by the device (such as instability,
20, 2015. and effectiveness of a class II device. entrapment, use error, falls and
FOR FURTHER INFORMATION CONTACT: John These factors are discussed in the associated injuries, battery/electrical/
Marszalek, Center for Devices and guidance that the Agency issued on mechanical failure, pressure sores,
Radiological Health, Food and Drug February 19, 1998, entitled ‘‘Procedures bruising, burns, electric shock, and
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Document Created: 2015-12-14 13:59:11
Document Modified: 2015-12-14 13:59:11
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final order. | |
| Dates | This order is effective November 20, 2015. The classification was applicable on December 20, 2011. | |
| 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. | |
| FR Citation | 80 FR 72587 |
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