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:20230609T174740Z DESCRIPTION:Date: Thursday\, July 20\, 2023 \nTime: 1 – 2:00 PM ET\n \nBa ckground:\nThe U.S. Food and Drug Administration (FDA)\, Center for Device s and Radiological Health (CDRH)\, will host a public webinar for medical device manufacturers and other stakeholders interested in learning more ab out the final guidance\, Content of Premarket Submissions for Device Softw are Functions\, and the recommendations for documentation sponsors should include in premarket submissions. \n \nWebinar Connection Instructions\n* We encourage you to join at least 15 minutes prior to the start of the we binar.\n* You do not need to register to attend.\n* We recommend you join via the Zoom app using the Zoom link provided below. Listen through your c omputer speakers and speak through your computer microphone/headset to ask a question. \n \n* Webinar Link: https://fda.zoomgov.com/j/1618744961?pwd =MmdVdEd1YnVscHF2K01TWlp6QU45QT09\n* Passcode: HHq6&G\n \nIf you join by p hone only without the Zoom link:\n* U.S. Callers Dial: 833-568-8864 (Toll Free)\n * For higher quality\, dial a number based on your current locati on:\n * +1 669 254 5252 US (San Jose)\n * +1 646 964 1167 US (US S panish Line)\n * +1 646 828 7666 US (New York)\n * +1 551 285 1373 US\n * +1 669 216 1590 US (San Jose)\n * +1 415 449 4000 US (US S panish Line)\n* International Callers Dial: Please check the international numbers available \n \n* Webinar ID : 161 874 4961\n* Passcode: 406547\n \n DTEND;TZID="Eastern Standard Time":20230720T140000 DTSTAMP:20230609T174740Z DTSTART;TZID="Eastern Standard Time":20230720T130000 LAST-MODIFIED:20230609T174740Z LOCATION:Zoom PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:FDA/CDRH Webinar - Content of Premarket Submissions for Device Software Functions\, Final Guidance TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E00800000000F0806EBEC89AD901000000000000000 010000000A06C7084E6375F4699FC70DFFC0CC8A8 X-ALT-DESC;FMTTYPE=text/html:< !--[if gte mso 9]>\n\n

Date: Thursday\, July 20\, 2023

< p class=MsoNormal style='background:white'>T ime: 1 –\; 2:00 PM ET

 \;

Background:

The U.S. Food and Drug Administration (FDA)\, Center for Devices and Radiological Health (CDRH)\, will host a public webinar for medical device manufacturers and other stakeholders interested in learning more about th e final guidance\, Content of Premarket Submissions for Device Software Fu nctions\, and the recommendations for documentation sponsors should includ e in premarket submissions.  \;< o:p>

 \;

Webinar Connection Instructions

  • We encourage you to join at least 15 minutes prior to the start of the webinar.
  • You do not need to register to attend.< /span>
  • We recommend you join via the Zoom app using the Zoom link provided below. Listen through your computer speakers and speak thro ugh your computer microphone/headset to ask a question.

 \;

  • Passcode: HHq6&\;G

 \;

If you join by phone only without the Zoom link:

  • U.S. Callers Dial:< /span> \; 833-568-8864 (Toll Free)
  • For higher quality\, dial a number based on your current location:
  •  \; \; \; +1 669 254 5252 US (San Jose )
  •  \; \; \; +1 646 964 1167 US (US Spanish Line)
  •  \; \; \; +1 646 828 7666 US (New York)
  •  \; \; \; +1 551 285 1373 US
  •  \; \; \; +1 669 216 1 590 US (San Jose)
  •  \; \; \; +1 415 449 4000 US (US Spanish Line)
  • < b>International Callers Dial: Please check the international numbers available
  •  \;

    • < b>Webinar ID: 161 874 4961
    • Passcode: 406547

     \;

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