BEGIN:VCALENDAR PRODID:-//Microsoft Corporation//Outlook 16.0 MIMEDIR//EN VERSION:2.0 METHOD:PUBLISH X-MS-OLK-FORCEINSPECTOROPEN:TRUE BEGIN:VTIMEZONE TZID:Eastern Standard Time BEGIN:STANDARD DTSTART:16011104T020000 RRULE:FREQ=YEARLY;BYDAY=1SU;BYMONTH=11 TZOFFSETFROM:-0400 TZOFFSETTO:-0500 END:STANDARD BEGIN:DAYLIGHT DTSTART:16010311T020000 RRULE:FREQ=YEARLY;BYDAY=2SU;BYMONTH=3 TZOFFSETFROM:-0500 TZOFFSETTO:-0400 END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT CLASS:PUBLIC CREATED:20210518T123613Z DESCRIPTION:Summary\nOn June 24\, 2021\, the U.S. Food and Drug Administrat ion (FDA) will host a webinar to share information and answer questions ab out the final guidance\, Testing and Labeling Medical Devices for Safety i n the Magnetic Resonance (MR) Environment . This guidance document pr ovides the FDA’s recommendations on testing to assess the safety and com patibility of medical devices in the MR Environment and the recommended fo rmat for Magnetic Resonance Imaging (MRI) Safety Information in medical de vice labeling. Ensuring the safety of patients who use magnetic resonance imaging (MRI) for disease diagnosis and health management is vital.\n \n \ nBackground\nOn May 19\, 2021\, the FDA issued the final guidance\, Testin g and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) E nvironment.\nDuring this webinar\, the FDA will:\n* Share information abou t the final guidance\, Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.\n* Answer your questions about th e guidance.\n \n \nStakeholder Call Details\nNo registration required.\nTi me: 11 a.m. – 12:30 p.m.\nPlease dial in at 10:45 a.m. to allow time to connect.\n \nU.S. Callers Dial:\n* 1-888-455-1392 \n* Conference number: P WXW2186446 \n* Passcode: 5723246\nInternational Callers Dial:\n* 1-773-799 -3847 \n* Conference number: PWXW2186446 \n* Passcode: 5723246\n \nTo view the slide presentation during the webinar: https://www.mymeetin gs.com/nc/join.php?i=PWXW2186446&p=5723246&t=c\n \n DTEND;TZID="Eastern Standard Time":20210624T123000 DTSTAMP:20210517T201638Z DTSTART;TZID="Eastern Standard Time":20210624T110000 LAST-MODIFIED:20210518T123613Z LOCATION:WebEx PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:FDA Webinar - Testing and Labeling Medical Devices f or Safety in the Magnetic Resonance (MR) Environment TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E00800000000C0C1EBC7374BD701000000000000000 0100000007256CC7454298043BD4EA8BAAC6FBC38 X-ALT-DESC;FMTTYPE=text/html:

Summary

O n June 24\, 2021\, the U.S. Food and Drug Administration (FDA) will host a webinar to share information and answer questions about the final guidanc e\, Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) En vironment. Th is guidance document provides the FDA’\;s recommendations on testing to assess the safety and compatibility of medical devices in the MR Enviro nment and the recommended format for Magnetic Resonance Imaging (MRI) Safe ty Information in medical device labeling. Ensuring the safety of patients who use magnetic resonance imaging (MRI) for disease diagnosis and health management is vital.

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Background

On May 19\, 2021\, the FDA issued the final guidan ce\, Testing and Labeling Medical Devices for Safety in the Magnetic Reson ance (MR) Environment.

During this webinar\, the FDA will:

  • Share information about the final guidance\, Testing a nd Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Envi ronment.
  • A nswer your questions about the guidance.

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Stakeholder Call Details

No registration required.

Time: 11 a.m. –\; 12 :30 p.m.

Please dial in at 10:45 a.m. to allow time to connect.

 \;

U.S. Callers Dial:

  • 1-888-455-1392
  • Conference number: PWXW2186446
  • Passcode: 5723246< /span>

International Callers Dial:

  • 1-773-799-3847  \; \; \; \; \;&n bsp\; \; \; \; \;
  • Confere nce number: PWXW2186446
  • Passcode: 5723246

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To view the slide presenta tion during the webinar: https://www.mymeetings.com/nc /join.php?i=PWXW2186446&\;p=5723246&\;t=c

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