Information To Support a Claim of Electromagnetic Compatibility of Electrically-Powered Medical Device; Guidance for Industry and Food and Drug Administration Staff; Availability, 44873-44875 [2016-16350]

Download as PDF sradovich on DSK3GDR082PROD with NOTICES Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices Registration: Registration is $250 for members of AAO, AAOpt, AAPOS, AOA, ASCRS, or CLAO; and $400 for non-members and available on a firstcome, first-served basis. Persons interested in attending this public workshop must register online. The deadline for online registration is September 23, 2016, at 4 p.m. EDT. There will be no onsite registration on the day of the public workshop. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If you need special accommodations due to a disability, please contact Ms. Susan Monahan at susan.monahan@ fda.hhs.gov or 301–796–5661 no later than September 16, 2016. To register for the public workshop, please visit http://www.cfom.info/ meetings/myopia/. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, telephone number, and membership in the cosponsoring organizations. If there are any questions with registration, please contact Mrs. Bobbi Hahn at bhahn@ cfom.info. Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. Food may be purchased in advance for $45 on the registration Web site (http://www.cfom.info/meetings/ myopia/). Food and beverages will also be available for purchase by participants during the workshop breaks. For more information on the workshop, please see the FDA’s Medical Devices News & Events—Workshops & Conferences calendar at http:// www.fda.gov/MedicalDevices/ NewsEvents/WorkshopsConferences/ default.htm. (Select this public workshop from the posted events list.) Those without Internet access should contact Bobbi Hahn to register at 651– 731–7257. Streaming Webcast of the Public Workshop: The public workshop will also be Webcast. Persons interested in viewing the Webcast must register online by September 23, 2016. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after September 23, 2016. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/ help/en/support/meeting_test.htm. To VerDate Sep<11>2014 16:55 Jul 08, 2016 Jkt 238001 get a quick overview of the Connect Pro program, visit http://www.adobe.com/ go/connectpro_overview. FDA has verified the Web site addresses in this document, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http:// www.regulations.gov. It may be viewed at the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A transcript will also be available in either hardcopy or on CD– ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency’s Web site at http:// www.fda.gov. A link to the transcript will also be available approximately 45 days after the public workshop on the Internet at http://www.fda.gov/ MedicalDevices/NewsEvents/ WorkshopsConferences/default.htm. (Select this public workshop from the posted events list). III. References The following references are on display in the Division of Dockets Management (see Transcripts) 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 http:// 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. Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses. U.S. Department of Health and Human Services, Food and Drug Administration. May 1994. http:// www.fda.gov/RegulatoryInformation/ Guidances/ucm080928.htm. 2. Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. U.S. Department of Health and Human Services, Food and Drug Administration. December 2009. http://www.fda.gov/downloads/Drugs/.../ Guidances/UCM193282.pdf. 3. Draft Guidance: Patient Preference Information—Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling. U.S. Department of Health and Human Services, Food and Drug Administration. Posted March 2015. http://www.fda.gov/downloads/ medicaldevices/ deviceregulationandguidance/ guidancedocuments/ucm446680.pdf. PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 44873 Dated: July 6, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–16353 Filed 7–8–16; 8:45 am] BILLING CODE 4164–01–P 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. 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 ElectricallyPowered 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: SUMMARY: 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, E:\FR\FM\11JYN1.SGM 11JYN1 44874 Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices sradovich on DSK3GDR082PROD with NOTICES 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 ElectricallyPowered 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 VerDate Sep<11>2014 16:55 Jul 08, 2016 Jkt 238001 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 ElectricallyPowered 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 selfaddressed 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 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 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 ElectricallyPowered 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 E:\FR\FM\11JYN1.SGM 11JYN1 44875 Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices 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 CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1400057 to identify the guidance you are requesting. 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. Notice. The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: [FR Doc. 2016–16350 Filed 7–8–16; 8:45 am] FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A63, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION: Dated: July 5, 2016. Leslie Kux, Associate Commissioner for Policy. 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 ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2009–N–0221; FDA– 2012–N–0559; FDA–2015–N–3287; FDA– 2015–N–3815; FDA–2007–D–0429; FDA– 2012–N–0447; FDA–2011–D–0597; FDA– 2011–D–0164; FDA–2013–N–0013; FDA– 2011–N–0146; FDA–2014–N–1533; FDA– 2011–N–0921; FDA–2015–N–2163] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: FOR FURTHER INFORMATION CONTACT: The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the Internet at http://www.reginfo.gov/public/do/ PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Food and Drug Administration, HHS. TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB OMB control No. Title of collection sradovich on DSK3GDR082PROD with NOTICES Food Labeling: Notification Procedures for Statements on Dietary Supplements .................................................. PHS Guideline on Infectious Disease Issues in Xenotransplantation .................................................................... MDUFMA Small Business Qualification Certification .............................................................................................. Electronic Submission of Medical Device Registration and Listing ........................................................................ Guidance for Industry on Q & A Regarding Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement & Nonprescription Drug Consumer Protection Act ....................................................................................................................................................... Antimicrobial Animal Drug Distribution Reports and Recordkeeping ...................................................................... Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring ................. Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act ........................................................................................................................................................................ Accreditation of Third Party Certification Bodies to Conduct Food Safety Audits and Issue Certifications ........... Sanitary Transportation of Human and Animal Food .............................................................................................. National Panel of Tobacco Consumer Studies ....................................................................................................... Standards for the Growing, Harvesting, Packaging, and Holding of Produce for Human Consumption ............... Hearing, Aging, and Direct-to-Consumer Television Advertisements ..................................................................... Dated: July 6, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–16349 Filed 7–8–16; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:39 Jul 08, 2016 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\11JYN1.SGM 11JYN1 Date approval expires 0910–0331 0910–0456 0910–0508 0910–0625 6/30/2019 6/30/2019 6/30/2019 6/30/2019 0910–0641 0910–0659 0910–0733 6/30/2019 6/30/2019 6/30/2019 0910–0734 0910–0750 0910–0773 0910–0815 0910–0816 0910–0818 6/30/2019 6/30/2019 6/30/2019 6/30/2019 6/30/2019 6/30/2019

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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