Document ID: FDA-2017-N-6216-0001
Agency: fda
Document Type: Proposed Rule
Title: General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device
Posted Date: 2017-11-07T05:00Z

[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Proposed Rules]
[Pages 51585-51589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24191]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. FDA-2017-N-6216]

General Hospital and Personal Use Devices; Reclassification of 
Sharps Needle Destruction Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this 
proposed order to reclassify the needle destruction device, renaming 
the device to ``sharps needle destruction device,'' a postamendments 
class III device (regulated under product code MTV), into class II 
(special controls), subject to premarket notification. FDA is also 
identifying the proposed special controls that the Agency believes are 
necessary to provide a reasonable assurance of safety and effectiveness 
of the device. FDA is proposing this reclassification on its own 
initiative based on new information. If finalized, this order will 
reclassify these types of devices from class III to class II and reduce 
regulatory burdens on industry as these types of devices will no longer 
be required to submit a premarket approval application (PMA) but can 
instead submit a less burdensome premarket notification (510(k)) before 
marketing their device.

DATES: Submit either electronic or written comments on the proposed 
order by January 8, 2018. Please see section XI of this document for 
the proposed effective date when the new requirements apply and for the 
proposed effective date of a final order based on this proposed order.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 8, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 8, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal Rulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-6216 for ``General Hospital and Personal Use Devices; 
Reclassification

[[Page 51586]]

of Sharps Needle Destruction Device.'' Received comments, those filed 
in a timely manner (see ADDRESSES), will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Christopher K. Dugard, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 2561, Silver Spring, MD 20993, 240-
402-6031, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as 
amended, establishes a comprehensive system for the regulation of 
medical devices intended for human use. Section 513 of the FD&C Act (21 
U.S.C. 360c) established three categories (classes) of devices, 
reflecting the regulatory controls needed to provide reasonable 
assurance of their safety and effectiveness. The three categories of 
devices are class I (general controls), class II (special controls), 
and class III (premarket approval).
    Devices that were not in commercial distribution prior to May 28, 
1976 (generally referred to as postamendments devices) are 
automatically classified by section 513(f)(1) of the FD&C Act into 
class III without any FDA rulemaking process. Those devices remain in 
class III and require premarket approval unless, and until, the device 
is 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 21 CFR part 807.
    A postamendments device that has been initially classified in class 
III under section 513(f)(1) of the FD&C Act may be reclassified into 
class I or class II under section 513(f)(3) of the FD&C Act. Section 
513(f)(3) of the FD&C Act provides that FDA acting by order can 
reclassify the device into class I or class II on its own initiative, 
or in response to a petition from the manufacturer or importer of the 
device. To change the classification of the device, the proposed new 
class must have sufficient regulatory controls to provide reasonable 
assurance of the safety and effectiveness of the device for its 
intended use.
    Reevaluation of the data previously before the Agency is an 
appropriate basis for subsequent action where the reevaluation is made 
in light of newly available regulatory authority (see Bell v. Goddard, 
366 F.2d 177, 181 (7th Cir. 1966); Ethicon, Inc. v. FDA, 762 F. Supp. 
382, 388-391 (D.D.C. 1991)) or in light of changes in ``medical 
science'' (Upjohn v. Finch, 422 F.2d 944, 951 (6th Cir. 1970)). Whether 
data before the Agency are old or new, the ``new information'' to 
support reclassification under 513(f)(3) must be ``valid scientific 
evidence'', as defined in section 513(a)(3) of the FD&C Act and 21 CFR 
860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (D.C. 
Cir. 1985); Contact Lens Assoc. v. FDA, 766 F.2d 592 (D.C. Cir.1985), 
cert. denied, 474 U.S. 1062 (1986)).
    FDA relies upon ``valid scientific evidence'' in the classification 
process to determine the level of regulation for devices. To be 
considered in the reclassification process, the ``valid scientific 
evidence'' upon which the Agency relies must be publicly available. 
Publicly available information excludes trade secret and/or 
confidential commercial information, e.g., the contents of a pending 
PMA (see section 520(c) of the FD&C Act (21 U.S.C. 360j(c)). Section 
520(h)(4) of the FD&C Act provides that FDA may use, for 
reclassification of a device, certain information in a PMA 6 years 
after the application has been approved. This includes information from 
clinical and preclinical tests or studies that demonstrate the safety 
or effectiveness of the device, but does not include descriptions of 
methods of manufacture or product composition and other trade secrets.
    Section 510(m) of the FD&C Act provides that a class II device may 
be exempted from the 510(k) premarket notification requirements, if the 
Agency determines that premarket notification is not necessary to 
reasonably assure the safety and effectiveness of the device.

II. Regulatory History of the Devices

    On February 3, 1994, FDA issued a Memorandum to manufacturers and 
initial distributors of sharps containers and destroyers used by health 
care manufacturers to clarify the regulatory status of sharps destroyer 
devices (Ref. 1).
    On March 6, 1997, FDA approved its first needle destruction device 
through its PMA process under section 515 of the FD&C Act (21 U.S.C. 
360e). In the June 11, 1997, Federal Register notice (62 FR 31831), FDA 
announced a PMA approval order for Millenium Medical Supply's 
Incorporated Needle-EaseTM 2501\1\ device and the 
availability of the Summary of Safety and Effectiveness Data for the 
Device (SSED) (Ref. 2). As of the date of issuance of this proposed 
order, FDA has approved 18 original PMAs for this device type.\2\
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    \1\ FDA approved a modified needle destruction device on 
February 11, 1998. The device, as modified, is marketed under the 
trade name Needle-Ease[supreg]3500.
    \2\ See PMA database for original PMAs regulated under the 
product code MTV: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm.

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[[Page 51587]]

    On March 2, 2001, FDA finalized guidance entitled, ``Premarket 
Approval Applications (PMA) for Sharps Needle Destruction Devices,'' 
describing the Agency's recommendations for information to include in 
PMA applications for sharps needle destruction devices intended for use 
in health care settings (Ref. 3).

III. Device Description

    A sharps needle destruction device is a postamendments device 
classified into class III under section 513(f)(1) of the FD&C Act. A 
sharps needle destruction device is a prescription device intended for 
home use or in professional health care facilities to destroy sharps or 
needles used for medical purposes by incineration or mechanical means. 
Sharps needle destruction devices are typically electrical devices that 
can destruct sharps and/or needles in a variety of methods (grinding, 
incinerating, etc.) that can be either portable or stationary. Some of 
these devices may also employ software to provide the user with greater 
control. Please note these devices were originally identified as needle 
destruction devices (product code MTV) in FDA SSEDs and product code 
database; however, FDA believes the identification of sharps needle 
destruction device more accurately describes this device type as it can 
be used to destroy devices other than needles (e.g., sharps).

IV. Proposed Reclassification

    As part of the Center for Devices and Radiological Health's 2014-
2015 strategic priority ``Strike the Right Balance Between Premarket 
and Postmarket Data Collection,'' a retrospective review of class III 
devices subject to PMA was completed to determine whether or not, based 
on our current understanding of the technology, reclassification may be 
appropriate. On August 8, 2016, FDA published a document in the Federal 
Register entitled ``Retrospective Review of Premarket Approval 
Application Devices; Striking the Balance Between Premarket and 
Postmarket Data Collection'' in which FDA announced plans to reclassify 
sharps needle destruction devices identified with the MTV product code 
from class III to class II (81 FR 52445). FDA has found that sufficient 
information exists to establish special controls that, together with 
general controls, can provide a reasonable assurance of safety and 
effectiveness for sharps needle destruction devices.
    In accordance with section 513(f)(3) of the FD&C Act and 21 CFR 
part 860, subpart C, FDA is proposing to reclassify this postamendments 
class III device into class II. FDA believes that there is sufficient 
information available to FDA through FDA's accumulated experience with 
these devices from review submissions, peer-reviewed literature, and 
knowledge of similar devices to establish special controls that 
effectively mitigate the risks to health identified in section V. 
Absent the special controls identified in this proposed order, general 
controls applicable to the device are insufficient to provide 
reasonable assurance of the safety and effectiveness of the device.
    FDA is proposing to create a separate classification regulation for 
sharps needle destruction devices that will be reclassified from class 
III to II. Under this proposed order, if finalized, the sharps needle 
destruction devices will be identified as a prescription device. As 
such, the prescription device must satisfy prescription labeling 
requirements (see Sec.  801.109 (21 CFR 801.109), Prescription 
devices). Prescription devices are exempt from the requirement for 
adequate directions for use for the layperson under section 502(f)(1) 
of the FD&C Act (21 U.S.C. 352(f)(1)) and Sec.  801.5 (21 CFR 801.5), 
as long as the conditions of Sec.  801.109 are met. In this proposed 
order, if finalized, the Agency has identified the special controls 
under section 513(a)(1)(B) of the FD&C Act that, together with general 
controls, will provide a reasonable assurance of the safety and 
effectiveness for sharps needle destruction devices.
    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 for sharps needle 
destruction devices to provide reasonable assurance of the safety and 
effectiveness. Therefore, the Agency does not intend to exempt these 
proposed class II devices from 510(k) requirements. Persons who intend 
to market this type of device must submit to FDA a 510(k) and receive 
clearance prior to marketing the device.

V. Risks to Health

    After considering the information available to FDA through review 
submissions, peer-reviewed literature, and knowledge of similar 
devices, FDA determined the probable risks to health associated with 
the use of sharps needle destruction devices are as follows:
     Patient/user exposure to environmental contaminants. 
Destroying a used sharp or needle may generate hazardous emissions from 
the device that may result in infection or respiratory problems for the 
patient and/or user. Contamination of the patient environment can occur 
through emission of toxic fumes or infectious aerosol when the device 
destroys a sharp by incineration or mechanical means, and may result 
from device malfunction (mechanical and/or software). The device may 
also become contaminated through regular usage and may cause cross-
contamination.
     Patient/user burns as a result of excessive heat discharge 
or spark formation. Excessive heat or sparks may be generated and 
discharged from the device during destruction of sharps that may burn 
the user.
     Electromagnetic interference. While in operation, the 
device may interfere with other electrically powered devices, causing 
them to malfunction.
     Electrical shock. While in operation, the device may 
discharge electricity that could shock the user.
     Sharps injury. Incompletely destroyed sharps, physical 
device instability, device malfunctions, or use error may pose a risk 
for a sharps injury to the user.

VI. Summary of Reasons for Reclassification

    FDA believes that the sharps needle destruction devices intended 
for home use or in professional health care facilities to reduce the 
incidence of needlesticks by destroying sharps and/or needles in a 
variety of methods (grinding, incinerating, etc.) should be 
reclassified from class III to class II in light of new information 
about the effectiveness of these devices. There is sufficient 
information to establish special controls for sharps needle destruction 
devices, in addition to general controls, which can provide reasonable 
assurance of safety and effectiveness of the device, as general 
controls themselves are insufficient to provide reasonable assurance of 
its safety and effectiveness. FDA believes that the risks to health 
associated with sharps needle destruction devices intended for home use 
or in professional health care facilities to reduce the incidence of 
needlesticks can be mitigated with special controls and that these 
mitigations will provide a reasonable assurance of its safety and 
effectiveness.
    Based on a reconsideration of the available information and data, 
FDA believes that there is valid scientific evidence of effectiveness 
for sharps

[[Page 51588]]

needle destruction devices to reduce the incidence of needlesticks.

VII. Summary of Data Upon Which the Reclassification Is Based

    FDA believes that the identified special controls, in addition to 
general controls, are necessary to provide reasonable assurance of 
safety and effectiveness of these devices. Taking into account the 
probable health benefits of the use of the device and the nature and 
known incidence of the risks of the device, FDA, on its own initiative, 
is proposing to reclassify this postamendments class III device into 
class II. FDA has considered and analyzed the following information: An 
inclusive search of the Agency's Manufacturer and User Facility Device 
Experience (MAUDE) database, which shows no adverse events for sharps 
needle destruction devices; data contained in PMAs approved 6 or more 
years before the date of this proposal (reviewed under section 
520(h)(4) of the FD&C Act, also known as the 6-year rule); a review of 
sharps containers regulated under 21 CFR 880.5570, which have similar 
intended uses, but different technology, and are currently regulated as 
class II devices; and one relevant article found from a literature 
search that discussed the benefits and the probable risks of these 
devices (Ref. 4).

VIII. Proposed Special Controls

    FDA believes that the following special controls, together with 
general controls, are sufficient to mitigate the risks to health 
described in section V and provide a reasonable assurance of safety and 
effectiveness for sharps needle destruction devices.
     Performance testing will demonstrate:
    [cir] The device's ability to contain or ventilate aerosols or 
fumes from device operation that may result in environmental 
contamination and cross-contamination. Performance testing will 
demonstrate that harmful fumes, such as ozone, are not emitted by the 
device during destruction of sharps needles.
    [cir] Excessive heat or sparks are not generated during device 
operation that may injure users or patients through characterization of 
the heat dissipation profile from the heat source to the enclosure 
surface, and the point of contact between the held syringe and the 
user. Performance testing will ensure the heat generated through normal 
operation of the device will not harm users or patients or affect 
circuit performance and useful life of the device.
    [cir] Complete destruction of sharps intended to be destructed to 
mitigate user injuries from incomplete sharps destruction by conducting 
performance testing such as simulated use demonstrating complete 
destruction of the sharps and/or needles intended to be destroyed.
    [cir] Mitigation of injuries from device instability through 
characterization of the vibrations and movement generated by the device 
to ensure device stability in the use environment.
     Validation of cleaning and disinfection instructions to 
demonstrate that the device can be safely and effectively reprocessed 
after use to minimize the risk of patient/user cross-contamination.
     Performance testing ensures electromagnetic compatibility 
with other devices under conditions which are consistent with the 
intended environment of device use.
     Electrical safety testing ensures the risk of shock to the 
patient/user is minimized.
     Software hazard analysis, as well as software verification 
and validation, ensures that software performs as intended and 
potential software malfunctions do not impact the performance of the 
device.
     Labeling to ensure proper use of the device, including 
warnings of the generation of excessive heat, potential for needle 
stick injuries, instructions for reprocessing, and instructions for 
installation (e.g., on a stable surface, adequate ventilation).
    Table 1 shows how FDA believes these special controls will mitigate 
each risk to health described in section V.

   Table 1--Risks to Health and Mitigation Measures for Sharps Needle
                           Destruction Devices
------------------------------------------------------------------------
         Identified risk to health               Mitigation measures
------------------------------------------------------------------------
Patient/user exposure to environmental      Performance testing.
 contaminants.                              Reprocessing validation.
                                            Software verification,
                                             validation, and hazard
                                             analysis.
                                            Labeling.
Patient/user burns........................  Performance testing.
                                            Labeling.
Electrical shock..........................  Electrical Safety Testing.
                                            Labeling.
Electromagnetic interference..............  Electromagnetic
                                             Compatibility (EMC)
                                             Testing.
                                            Labeling.
Sharps injury.............................  Performance testing.
                                            Software verification,
                                             validation, and hazard
                                             analysis.
                                            Labeling.
------------------------------------------------------------------------

    In addition, FDA is proposing to limit these devices to 
prescription use under Sec.  801.109. Prescription devices are exempt 
from the requirement for adequate directions for use for the layperson 
under section 502(f)(1) of the FD&C Act and Sec.  801.5, as long as the 
conditions of Sec.  801.109 are met (referring to 21 U.S.C. 352(f)(1)). 
Under 21 CFR 807.81, the device would continue to be subject to 510(k) 
notification requirements. FDA does not believe that clinical data is 
necessary to mitigate the identified risks to health for sharps needle 
destruction devices. FDA may request clinical data to evaluate 
substantial equivalence when a manufacturer includes new indications 
for use, such as indications for disease prevention or organism 
destruction.
    This reclassification order and the identified special controls, if 
finalized, would provide sufficient detail regarding FDA's requirements 
to reasonably assure safety and effectiveness of sharps needle 
destruction devices. FDA intends to withdraw the final guidance 
entitled, ``Premarket Approval Applications (PMA) for Sharps Needle 
Destruction Devices; Final Guidance for Industry and FDA'' issued in 
2001 upon finalization of this proposed reclassification order (Ref. 
3).

IX. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

X. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed order contains no new 
collections of information. Therefore, clearance by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520) is not required. This proposed order refers 
to previously approved collections of information

[[Page 51589]]

found in FDA regulations. These collections of information are subject 
to review by OMB under the PRA. The collections of information in 21 
CFR part 807, subpart E have been approved under OMB control number 
0910-0120 and the collections of information under 21 CFR part 801 have 
been approved under OMB control number 0910-0485.

XI. Proposed Effective Date

    FDA proposes that any final order based on this proposal become 
effective 30 days after the date of its publication in the Federal 
Register.

XII. References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

    1. FDA memorandum ``To Manufacturers and Initial Distributors of 
Sharps Containers and Destroyers Used by Health Care 
Professionals,'' February 3, 1994, available at: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070679.pdf.
    2. FDA ``Premarket Approval of Millenium Medical Supply 
Incorporated Needle-EaseTM 2501-ACTION,'' March 6, 1997, 
available at: https://www.accessdata.fda.gov/cdrh_docs/pdf/p960044.pdf.
    3. ``Premarket Approval Applications (PMA) for Sharps Needle 
Destruction Devices; Final Guidance for Industry and FDA,'' March 2, 
2001, available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073601.pdf.
    4. Tamplin S.A., D. Davidson, B. Powis, and Z. O'Leary, ``Issues 
and Options for the Safe Destruction and Disposal of Used Injection 
Materials,'' Waste Management, vol. 25, pp. 655-665, 2005.

List of Subjects in 21 CFR Part 880

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321 et seq., as amended) and under authority delegated to the 
Commissioner of Food and Drugs, it is proposed that 21 CFR part 880 be 
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, 371.

0
2. Add Sec.  880.6210 to subpart G to read as follows:

Sec.  880.6210  Sharps needle destruction device.

    (a) Identification. A sharps needle destruction device is a 
prescription device that is intended to destroy needles or sharps used 
for medical purposes by incineration or mechanical means.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Performance testing must demonstrate the following during 
operation of the device:
    (i) The device safely contains or ventilates aerosols or fumes from 
device operation.
    (ii) Excessive heat or sparks are not generated that may injure 
users or patients.
    (iii) Simulated use testing must demonstrate sharps and/or needles 
are completely destroyed using a range of types and sizes of sharps 
sufficient to represent actual use.
    (iv) Simulated use testing must demonstrate that the device is 
physically stable on the surface for which it is intended to be mounted 
to ensure the risk of harm to the patient/user as a result of the 
device falling is minimized.
    (2) Validation of cleaning and disinfection instructions must 
demonstrate that the device can be safely and effectively reprocessed 
after use per the recommended cleaning and disinfection protocol in the 
instructions for use.
    (3) Analysis and/or testing must validate electromagnetic 
compatibility (EMC) and electrical safety, including the safety of any 
battery used in the device, under conditions which are consistent with 
the intended environment of device use.
    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) Labeling must include:
    (i) A clear description of the device and its technological 
features;
    (ii) How the device is to be used, including validated cleaning and 
disinfection instructions;
    (iii) Relevant precautions and warnings based on performance and 
in-use testing to ensure proper use of the device; and
    (iv) Instructions to install device in adequately ventilated area 
and stable area.

    Dated: November 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24191 Filed 11-6-17; 8:45 am]
 BILLING CODE 4164-01-P