80_FR_67622 80 FR 67411 - Information To Support a Claim of Electromagnetic Compatibility of Electrically Powered Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

80 FR 67411 - Information To Support a Claim of Electromagnetic Compatibility of Electrically Powered Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 211 (November 2, 2015)

Page Range67411-67412
FR Document2015-27818

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically- Powered Medical Devices.'' This guidance describes the types of information that should be provided to support a claim of electromagnetic compatibility (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. This draft guidance is not final nor is it in effect at this time.

Federal Register, Volume 80 Issue 211 (Monday, November 2, 2015)
[Federal Register Volume 80, Number 211 (Monday, November 2, 2015)]
[Notices]
[Pages 67411-67412]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27818]


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

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of Electrically Powered Medical Devices; Draft Guidance for Industry 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the availability of the draft guidance entitled ``Information to 
Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-
Powered Medical Devices.'' This guidance describes the types of 
information that should be provided to support a claim of 
electromagnetic compatibility (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. This draft guidance is not 
final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment of this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by December 17, 2015.

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, 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 Devices.'' 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 draft guidance document entitled 
``Information to Support a Claim of Electromagnetic Compatibility (EMC) 
of Electrically-Powered Medical Devices'' 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.

[[Page 67412]]


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 draft guidance to provide 
FDA's current thinking on the types of information that should be 
provided in a premarket submission to support a claim of 
electromagnetic compatibility for an electrically powered medical 
device. EMI is a hazard with associated risk for electrically powered 
medical devices. EMC assessment can help to ensure that the risks 
associated with performance degradation of electrically powered medical 
devices due to EMI are adequately mitigated.
    The draft 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. This draft guidance is intended to help ensure that 
clear and consistent information is provided in premarket submissions 
regarding medical device EMC and to facilitate the review of 
submissions with EMC claims.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on information 
that should be provided to support claims of electromagnetic 
compatibility of electrically powered medical devices. 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 statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the Internet. A search 
capability for all Center for Devices and Radiological 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 Devices'' 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 draft 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 sections 
520(m) and 515A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j and 21 U.S.C. 360e-1, respectively) and 613(b) of Food and Drug 
Administration Safety and Innovation Act have been approved under OMB 
control number 0910-0661.

    Dated: October 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27818 Filed 10-30-15; 8:45 am]
BILLING CODE 4164-01-P



                                                                                Federal Register / Vol. 80, No. 211 / Monday, November 2, 2015 / Notices                                          67411

                                                    The draft guidance, when finalized, will                10.115(g)(5)), to ensure that the Agency              Management between 9 a.m. and 4 p.m.,
                                                    represent the Agency’s current thinking                 considers your comment of this draft                  Monday through Friday.
                                                    on the design of BE studies to support                  guidance before it begins work on the                    • Confidential Submissions—To
                                                    ANDAs for progesterone gel. It does not                 final version of the guidance, submit                 submit a comment with confidential
                                                    establish any rights for any person and                 either electronic or written comments                 information that you do not wish to be
                                                    is not binding on FDA or the public.                    on the draft guidance by December 17,                 made publicly available, submit your
                                                    You can use an alternative approach if                  2015.                                                 comments only as a written/paper
                                                    it satisfies the requirements of the                    ADDRESSES: You may submit comments                    submission. You should submit two
                                                    applicable statutes and regulations.                    as follows:                                           copies total. One copy will include the
                                                                                                                                                                  information you claim to be confidential
                                                    II. Electronic Access                                   Electronic Submissions                                with a heading or cover note that states
                                                       Persons with access to the Internet                    Submit electronic comments in the                   ‘‘THIS DOCUMENT CONTAINS
                                                    may obtain the document at either                       following way:                                        CONFIDENTIAL INFORMATION’’. The
                                                    http://www.fda.gov/Drugs/Guidance                         • Federal eRulemaking Portal: http://               Agency will review this copy, including
                                                    ComplianceRegulatoryInformation/                        www.regulations.gov. Follow the                       the claimed confidential information, in
                                                    Guidances/default.htm or http://                        instructions for submitting comments.                 its consideration of comments. The
                                                    www.regulations.gov.                                    Comments submitted electronically,                    second copy, which will have the
                                                      Dated: October 27, 2015.                              including attachments, to http://                     claimed confidential information
                                                    Leslie Kux,                                             www.regulations.gov will be posted to                 redacted/blacked out, will be available
                                                    Associate Commissioner for Policy.                      the docket unchanged. Because your                    for public viewing and posted on
                                                                                                            comment will be made public, you are                  http://www.regulations.gov. Submit
                                                    [FR Doc. 2015–27816 Filed 10–30–15; 8:45 am]
                                                                                                            solely responsible for ensuring that your             both copies to the Division of Dockets
                                                    BILLING CODE 4164–01–P
                                                                                                            comment does not include any                          Management. If you do not wish your
                                                                                                            confidential information that you or a                name and contact information to be
                                                    DEPARTMENT OF HEALTH AND                                third party may not wish to be posted,                made publicly available, you can
                                                    HUMAN SERVICES                                          such as medical information, your or                  provide this information on the cover
                                                                                                            anyone else’s Social Security number, or              sheet and not in the body of your
                                                    Food and Drug Administration                            confidential business information, such               comments and you must identify this
                                                                                                            as a manufacturing process. Please note               information as ‘‘confidential.’’ Any
                                                    [Docket No. FDA–2015–D–3787]                                                                                  information marked as ‘‘confidential’’
                                                                                                            that if you include your name, contact
                                                                                                            information, or other information that                will not be disclosed except in
                                                    Information To Support a Claim of
                                                                                                            identifies you in the body of your                    accordance with 21 CFR 10.20 and other
                                                    Electromagnetic Compatibility of
                                                                                                            comments, that information will be                    applicable disclosure law. For more
                                                    Electrically Powered Medical Devices;
                                                                                                            posted on http://www.regulations.gov.                 information about FDA’s posting of
                                                    Draft Guidance for Industry and Food
                                                    and Drug Administration Staff;                            • If you want to submit a comment                   comments to public dockets, see 80 FR
                                                                                                            with confidential information that you                56469, September 18, 2015, or access
                                                    Availability
                                                                                                            do not wish to be made available to the               the information at: http://www.fda.gov/
                                                    AGENCY:    Food and Drug Administration,                public, submit the comment as a                       regulatoryinformation/dockets/
                                                    HHS.                                                    written/paper submission and in the                   default.htm.
                                                    ACTION:   Notice of availability.                       manner detailed (see ‘‘Written/Paper                     Docket: For access to the docket to
                                                                                                            Submissions’’ and ‘‘Instructions’’).                  read background documents or the
                                                    SUMMARY: The Food and Drug                                                                                    electronic and written/paper comments
                                                    Administration (FDA or Agency) is                       Written/Paper Submissions                             received, go to http://
                                                    announcing the availability of the draft                   Submit written/paper submissions as                www.regulations.gov and insert the
                                                    guidance entitled ‘‘Information to                      follows:                                              docket number, found in brackets in the
                                                    Support a Claim of Electromagnetic                         • Mail/Hand delivery/Courier (for                  heading of this document, into the
                                                    Compatibility (EMC) of Electrically-                    written/paper submissions): Division of               ‘‘Search’’ box and follow the prompts
                                                    Powered Medical Devices.’’ This                         Dockets Management (HFA–305), Food                    and/or go to the Division of Dockets
                                                    guidance describes the types of                         and Drug Administration, 5630 Fishers                 Management, 5630 Fishers Lane, Rm.
                                                    information that should be provided to                  Lane, Rm. 1061, Rockville, MD 20852.                  1061, Rockville, MD 20852.
                                                    support a claim of electromagnetic                         • For written/paper comments                          An electronic copy of the guidance
                                                    compatibility (EMC) in a premarket                      submitted to the Division of Dockets                  document is available for download
                                                    submission for an electrically powered                  Management, FDA will post your                        from the Internet. See the
                                                    medical device. Electromagnetic                         comment, as well as any attachments,                  SUPPLEMENTARY INFORMATION section for
                                                    disturbance is electronic product                       except for information submitted,                     information on electronic access to the
                                                    radiation that may interfere with the                   marked and identified, as confidential,               guidance. Submit written requests for a
                                                    performance of an electrically powered                  if submitted as detailed in                           single hard copy of the draft guidance
                                                    medical device in its intended                          ‘‘Instructions.’’                                     document entitled ‘‘Information to
                                                    environment (i.e., cause an                                Instructions: All submissions received             Support a Claim of Electromagnetic
                                                    electromagnetic interference (EMI)).                    must include the Docket No. FDA–                      Compatibility (EMC) of Electrically-
                                                    EMC assessment helps to ensure that a                   2015–D–3787 for ‘‘Information to                      Powered Medical Devices’’ to the Office
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    device is able to function in its intended              Support a Claim of Electromagnetic                    of the Center Director, Guidance and
                                                    environment without introducing                         Compatibility (EMC) of Electrically-                  Policy Development, Center for Devices
                                                    excessive electromagnetic disturbances                  Powered Medical Devices.’’ Received                   and Radiological Health, Food and Drug
                                                    that might interfere with other devices.                comments will be placed in the docket                 Administration, 10903 New Hampshire
                                                    This draft guidance is not final nor is it              and, except for those submitted as                    Ave., Bldg. 66, Rm. 5431, Silver Spring,
                                                    in effect at this time.                                 ‘‘Confidential Submissions,’’ publicly                MD 20993–0002. Send one self-
                                                    DATES: Although you can comment on                      viewable at http://www.regulations.gov                addressed adhesive label to assist that
                                                    any guidance at any time (see 21 CFR                    or at the Division of Dockets                         office in processing your request.


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                                                    67412                       Federal Register / Vol. 80, No. 211 / Monday, November 2, 2015 / Notices

                                                    FOR FURTHER INFORMATION CONTACT:                        II. Significance of Guidance                            Dated: October 27, 2015.
                                                    Donald Witters, Center for Devices and                    This draft guidance is being issued                 Leslie Kux,
                                                    Radiological Health, Food and Drug                      consistent with FDA’s good guidance                   Associate Commissioner for Policy.
                                                    Administration, 10903 New Hampshire                     practices regulation (21 CFR 10.115).                 [FR Doc. 2015–27818 Filed 10–30–15; 8:45 am]
                                                    Ave. Bldg. 62, Rm. 1130, Silver Spring,                 The draft guidance, when finalized, will              BILLING CODE 4164–01–P
                                                    MD 20993–0002, 301–796–2483.                            represent the current thinking of FDA
                                                    SUPPLEMENTARY INFORMATION:                              on information that should be provided
                                                                                                            to support claims of electromagnetic                  DEPARTMENT OF HEALTH AND
                                                    I. Background                                           compatibility of electrically powered                 HUMAN SERVICES
                                                                                                            medical devices. It does not establish
                                                       FDA is announcing the availability of                                                                      Office of the Secretary
                                                                                                            any rights for any person and is not
                                                    a draft guidance to provide FDA’s
                                                                                                            binding on FDA or the public. You can                 [Document Identifier: HHS–OS–4040–New–
                                                    current thinking on the types of                        use an alternative approach if it satisfies           60D]
                                                    information that should be provided in                  the requirements of the applicable
                                                    a premarket submission to support a                     statute and regulations.                              Agency Information Collection
                                                    claim of electromagnetic compatibility                                                                        Activities; Proposed Collection; Public
                                                    for an electrically powered medical                     III. Electronic Access                                Comment Request
                                                    device. EMI is a hazard with associated                    Persons interested in obtaining a copy
                                                    risk for electrically powered medical                                                                         AGENCY:   Office of the Secretary, HHS.
                                                                                                            of the draft guidance may do so by
                                                    devices. EMC assessment can help to                                                                           ACTION:   Notice.
                                                                                                            downloading an electronic copy from
                                                    ensure that the risks associated with                   the Internet. A search capability for all             SUMMARY: In compliance with section
                                                    performance degradation of electrically                 Center for Devices and Radiological                   3506(c)(2)(A) of the Paperwork
                                                    powered medical devices due to EMI are                  Health guidance documents is available                Reduction Act of 1995, the Office of the
                                                    adequately mitigated.                                   at http://www.fda.gov/MedicalDevices/                 Secretary (OS), Department of Health
                                                       The draft guidance includes                          DeviceRegulationandGuidance/                          and Human Services, announces plans
                                                    information consistent with                             GuidanceDocuments/default.htm.                        to submit a new Information Collection
                                                    specifications described in FDA-                        Guidance documents are also available                 Request (ICR), described below, to the
                                                    recognized consensus national or                        at http://www.regulations.gov. Persons                Office of Management and Budget
                                                    international standards for EMC such as                 unable to download an electronic copy                 (OMB). Prior to submitting the ICR to
                                                    in the International Electrotechnical                   of ‘‘Information to Support a Claim of                OMB, OS seeks comments from the
                                                    Commission (IEC) 60601–1–2: Edition 3:                  Electromagnetic Compatibility (EMC) of                public regarding the burden estimate,
                                                    2007–03, Medical Electrical                             Electrically-Powered Medical Devices’’                below, or any other aspect of the ICR.
                                                    Equipment—Part 1–2: General                             may send an email request to CDRH-                    DATES: Comments on the ICR must be
                                                    Requirements for Basic Safety and                       Guidance@fda.hhs.gov to receive an                    received on or before January 4, 2016.
                                                    Essential Performance—Collateral                        electronic copy of the document. Please
                                                                                                                                                                  ADDRESSES: Submit your comments to
                                                    Standard: Electromagnetic                               use the document number 1400057 to
                                                                                                            identify the guidance you are                         Information.CollectionClearance@
                                                    Compatibility—Requirements and Tests;                                                                         hhs.gov or by calling (202) 690–6162.
                                                                                                            requesting.
                                                    IEC 60601–1–2: Edition 4.0: 2014–01,                                                                          FOR FURTHER INFORMATION CONTACT:
                                                    Medical Electrical Equipment, Part 1–2:                 IV. Paperwork Reduction Act of 1995                   Information Collection Clearance staff,
                                                    General Requirements for Basic Safety                     This draft guidance refers to                       Information.CollectionClearance@
                                                    and Essential Performance—Collateral                    previously approved collections of                    hhs.gov or (202) 690–6162.
                                                    Standard: Electromagnetic                               information found in FDA regulations.                 SUPPLEMENTARY INFORMATION: When
                                                    Disturbances—Requirements and Tests;                    These collections of information are                  submitting comments or requesting
                                                    Association for the Advancement of                      subject to review by the Office of                    information, please include the
                                                    Medical Instrumentation (AAMI)/                         Management and Budget (OMB) under                     document identifier HHS–OS–4040–
                                                    American National Standards Institute                   the Paperwork Reduction Act of 1995                   New–60D for reference.
                                                    (ANSI)/IEC 60601–1–2: 2007/(R) 2012                     (44 U.S.C. 3501–3520). The collections                   Information Collection Request Title:
                                                    Medical Electrical Equipment—Part 1–                    of information in 21 CFR part 814 have                DATA Act Sec. 5. ‘‘Simplifying Federal
                                                    2: General Requirements for Basic Safety                been approved under OMB control                       Award Reporting’’ Grants Pilot.
                                                    and Essential Performance—Collateral                    number 0910–0231. The collections of                     Abstract: Public Law 113–101, The
                                                    Standard: Electromagnetic                               information in 21 CFR part 807, subpart               Digital Accountability and
                                                    Compatibility—Requirements and Tests;                   E have been approved under OMB                        Transparency Act of 2014 (DATA Act)
                                                    and AAMI/ANSI/IEC 60601–1–2: 2014,                      control number 0910–0120. The                         expands the Federal Funding
                                                    Medical Electrical Equipment—Part 1–                    collections of information in 21 CFR                  Accountability and Transparency Act of
                                                    2: General Requirements for Basic Safety                part 812 have been approved under                     2006 by increasing accountability and
                                                    and Essential Performance—Collateral                    OMB control number 0910–0078. The                     transparency in Federal spending.
                                                    Standard: Electromagnetic                               collections of information in 21 CFR                  Section 5 of the DATA Act (‘‘Sec. 5.
                                                    Disturbances—Requirements and Tests                     part 814, subpart H have been approved                Simplifying Federal Award Reporting’’)
                                                    Standards that sponsors and                             under OMB control number 0910–0332.                   tasks the Director of the Office of
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    manufacturers of electrically powered                   The collections of information in                     Management and Budget (OMB) to
                                                    medical devices often reference. This                   sections 520(m) and 515A of the Federal               establish a pilot program (Sec. 5 (b)).
                                                    draft guidance is intended to help                      Food, Drug, and Cosmetic Act (21 U.S.C.                  OMB has designated the Department
                                                    ensure that clear and consistent                        360j and 21 U.S.C. 360e–1, respectively)              of Health and Human Services (HHS) as
                                                    information is provided in premarket                    and 613(b) of Food and Drug                           the executing agent of the pilot program.
                                                    submissions regarding medical device                    Administration Safety and Innovation                  Within HHS, the DATA Act Program
                                                    EMC and to facilitate the review of                     Act have been approved under OMB                      Management Office (PMO) (DAP) has
                                                    submissions with EMC claims.                            control number 0910–0661.                             been established under the Office of the


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Document Created: 2018-03-01 11:30:50
Document Modified: 2018-03-01 11:30:50
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesAlthough you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 17, 2015.
ContactDonald 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.
FR Citation80 FR 67411 

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