Document ID: FDA-2015-D-3787-0006
Agency: fda
Document Type: Notice
Title: Information To Support a Claim of Electromagnetic Compatibility of Electrically-Powered Medical Device; Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2016-07-11T04:00Z

[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44873-44875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16350]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-3787]

Information To Support a Claim of Electromagnetic Compatibility 
of Electrically-Powered Medical Device; Guidance for Industry and Food 
and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the guidance entitled ``Information to Support a 
Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered 
Medical Device.'' This guidance describes the types of information that 
should be provided to support a claim of EMC in a premarket submission 
for an electrically powered medical device. Electromagnetic disturbance 
is electronic product radiation that may interfere with the performance 
of an electrically powered medical device in its intended environment 
(i.e., cause an electromagnetic interference (EMI)). EMC assessment 
helps to ensure that a device is able to function in its intended 
environment without introducing excessive electromagnetic disturbances 
that might interfere with other devices.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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,

[[Page 44874]]

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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2015-D-3787 for ``Information to Support a Claim of Electromagnetic 
Compatibility (EMC) of Electrically-Powered Medical Device.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Information to Support a Claim of Electromagnetic Compatibility (EMC) 
of Electrically-Powered Medical Device'' to the Office of the Center 
Director, Guidance and Policy Development, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request.

FOR FURTHER INFORMATION CONTACT: Donald Witters, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 62, Rm. 1130, Silver Spring, MD 20993-0002, 301-796-2483.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a final guidance to provide 
FDA's current thinking about the information that should be provided in 
a premarket submission to support a claim of EMC for an electrically 
powered medical device. The assessment of EMC helps to ensure that the 
risks associated with performance degradation of electrically powered 
medical devices due to EMI are adequately mitigated. This guidance is 
intended to ensure that clear and consistent information regarding 
medical device EMC are provided in premarket submissions to facilitate 
the review of submissions with EMC claims associated with safety and 
effectiveness.
    The guidance includes information consistent with specifications 
described in FDA-recognized consensus national or international 
standards for EMC such as in the International Electrotechnical 
Commission (IEC) 60601-1-2: Edition 3: 2007-03, Medical Electrical 
Equipment--Part 1-2: General Requirements for Basic Safety and 
Essential Performance--Collateral Standard: Electromagnetic 
Compatibility--Requirements and Tests; IEC 60601-1-2: Edition 4.0: 
2014-01, Medical Electrical Equipment, Part 1-2: General Requirements 
for Basic Safety and Essential Performance--Collateral Standard: 
Electromagnetic Disturbances--Requirements and Tests; Association for 
the Advancement of Medical Instrumentation (AAMI)/American National 
Standards Institute (ANSI)/IEC 60601-1-2: 2007/(R) 2012 Medical 
Electrical Equipment--Part 1-2: General Requirements for Basic Safety 
and Essential Performance--Collateral Standard: Electromagnetic 
Compatibility--Requirements and Tests; and AAMI/ANSI/IEC 60601-1-2: 
2014, Medical Electrical Equipment--Part 1-2: General Requirements for 
Basic Safety and Essential Performance--Collateral Standard: 
Electromagnetic Disturbances--Requirements and Tests Standards that 
sponsors and manufacturers of electrically powered medical devices 
often reference.
    The draft guidance of ``Information to Support a Claim of 
Electromagnetic Compatibility (EMC) of Electrically-Powered Medical 
Device'' was posted November 2, 2015, for public comment, and the 
comment period ended on December 17, 2015. Three sets of comments were 
received during the comment period.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on the information that should be provided to 
support a claim of EMC of electrically-powered medical device. It does 
not establish any rights for any person and is not binding on FDA or 
the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological

[[Page 44875]]

Health guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of 
``Information to Support a Claim of Electromagnetic Compatibility (EMC) 
of Electrically-Powered Medical Device'' may send an email request to 
CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the 
document. Please use the document number 1400057 to identify the 
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in 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 21 CFR part 814 have been approved under 
OMB control number 0910-0231. The collections of information in 21 CFR 
part 807, subpart E have been approved under OMB control number 0910-
0120. The collections of information in 21 CFR part 812 have been 
approved under OMB control number 0910-0078. The collections of 
information in 21 CFR part 814, subpart H have been approved under OMB 
control number 0910-0332. The collections of information in the 
guidance document ``Guidance for HDE Holders, Institutional Review 
Boards (IRBs), Clinical Investigators, and FDA Staff--Humanitarian 
Device Exemption (HDE) Regulation: Questions and Answers'' have been 
approved under OMB control number 0910-0661.

    Dated: July 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16350 Filed 7-8-16; 8:45 am]
 BILLING CODE 4164-01-P