80 FR 67411 - Information To Support a Claim of Electromagnetic Compatibility of Electrically Powered Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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)
Food and Drug Administration
Federal Register Volume 80, Issue 211 (November 2, 2015)
| Page Range | 67411-67412 | |
| FR Document | 2015-27818 |
[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Information To Support a Claim of Electromagnetic Compatibility of Electrically Powered Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically- Powered Medical Devices.''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 This draft guidance is not final nor is it in effect at this time.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 17, 2015.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
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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. | |
| FR Citation | 80 FR 67411 |
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