[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,
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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
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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
[email protected] 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]
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