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2016-07-09
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Information To Support a Claim of Electromagnetic Compatibility of Electrically-Powered Medical Device; Guidance for Industry and Food and Drug Administration Staff; Availability
Notices
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D09002ee1bdc1783f
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
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.
81 FR 44873
https://www.govinfo.gov/app/details/FR-2016-07-11/2016-16350
2016-16350
fr11jy16-63
4164-01-P
Docket No. FDA-2015-D-3787
https://www.govinfo.gov/app/details/FR-2016-07-11/2016-16350
https://www.govinfo.gov/content/pkg/FR-2016-07-11/html/2016-16350.htm
https://www.govinfo.gov/content/pkg/FR-2016-07-11/pdf/2016-16350.pdf
3 p.
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81 FR 44873
Information To Support a Claim of Electromagnetic Compatibility of Electrically-Powered Medical Device; Guidance for Industry and Food and Drug Administration Staff; Availability; Federal Register Vol. 81, Issue
NOTICE
2016-16350
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2015-D-3787
4164-01-P
2016-16350
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 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.
Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.
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.
Guidance:
Information to Support a Claim of Electromagnetic Compatibility of Electrically-Powered Medical Device
,
CDRH-Guidance@fda.hhs.gov
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
http://www.fda.gov/regulatoryinformation/dockets/default.htm
http://www.regulations.gov
Federal Register
Vol. 81, no. 132
Office of the Federal Register, National Archives and Records Administration
2016-07-11
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230 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2016-07-11
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0097-6326
0042-1219
0364-1406
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000582072
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https://www.govinfo.gov/app/details/FR-2016-07-11
https://www.govinfo.gov/content/pkg/FR-2016-07-11/pdf/FR-2016-07-11.pdf
https://www.govinfo.gov/content/pkg/FR-2016-07-11/xml/FR-2016-07-11.xml
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FR-2016-07-11
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