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:20230912T202436Z DESCRIPTION:Date: Tuesday\, November 14\, 2023 \nTime: 1 – 2:00 PM ET\n \ nBackground:\nThe U.S. Food and Drug Administration (FDA) will host a webi nar for the medical device industry and other interested stakeholders to d iscuss the updated Breakthrough Devices Program final guidance. \n \nWebin ar Connection Instructions\n* We encourage you to join at least 15 minutes prior to the start of the webinar.\n* You do not need to register to atte nd.\n* We recommend you join via the Zoom app using the Zoom link provided below. Listen through your computer speakers and speak through your compu ter microphone/headset to ask a question. \n \n* Webinar Link: https://fda .zoomgov.com/j/1601919917?pwd=aEZnMG1BcVdnaENDYzJBQ3NBU1Z4UT09 \n* Passcod e: t0Y6?C\n \nIf you join by phone only without the Zoom link:\n* U.S. Cal lers Dial: 833-568-8864 (Toll Free)\n * For higher quality\, dial a numbe r based on your current location:\n * +1 669 254 5252 US (San Jose)\n * +1 646 964 1167 US (US Spanish Line)\n * +1 646 828 7666 US (New York)\n * +1 551 285 1373 US (New Jersey)\n * +1 669 216 1590 US (San Jose)\n * +1 415 449 4000 US (US Spanish Line)\n* International C allers Dial: Please check the international numbers available \n \n* Webinar ID: 160 191 9917\n* Passcode: 84 6759\n \n \n DTEND;TZID="Eastern Standard Time":20231114T140000 DTSTAMP:20230908T193106Z DTSTART;TZID="Eastern Standard Time":20231114T130000 LAST-MODIFIED:20230912T202436Z LOCATION:Zoom PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:FDA/CDRH Webinar - Breakthrough Devices Program\, Fi nal Guidance TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E008000000000078F602A2CAD901000000000000000 0100000004021FF3FB0427043B8F8E7D93A34D03D X-ALT-DESC;FMTTYPE=text/html:\n\n\n

Da te: Tuesday\, November 14\, 2023

Time: 1 –\; 2:00 PM E T

&n bsp\;

< span style='mso-fareast-font-family:"Times New Roman"\;color:#333333'>Back ground:

The U.S. Food and Drug Administration (FDA) will host a webinar for the me dical device industry and other interested stakeholders to discuss the upd ated Breakthrough Devices Program final guidance.

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We binar Connection Instructions

  • We encourage y ou to join at least 15 minutes prior to the start of the webinar.
  • You do not need to register to attend.
  • We recommend you join via the Zoom app using the Zoom link prov ided below. Listen through your computer speakers and speak through your c omputer microphone/headset to ask a question.

 \;

  • Passcode: t0Y6?C

 \ ;

If you join by phone only without the Zoo m link:

  • U.S. Calle rs Dial: \; 833-568-8864 (To ll Free)
    • For higher qu ality\, dial a number based on your current location:
    •  \; \; \; +1 669 254 5252 US (S an Jose)
    •  \; \; \; +1 646 964 1167 US (US Spanish Line)
    •  \; \; \; +1 646 828 7666 US (New York)< o:p>
    •  \; \; \; + 1 551 285 1373 US (New Jersey)
    •  \; \; \; +1 669 216 1590 US (San Jose)
    • < span style='mso-spacerun:yes'> \; \; \; +1 415 449 4000 US (US Spanish Line)
  • International Callers Dial: Please check the international numb ers available

 \;

  • Webinar ID: 160 191 9917
  • Passcode: 8 46759

 \;

 \;

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