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:20211115T210837Z DESCRIPTION:Date/Time: December 16\, 2021 (Thursday)\, from 1 – 2 pm ET\n \nBackground:\nThe U.S. Food and Drug Administration (FDA)\, Center for D evices and Radiological Health (CDRH)\, will host a public webinar about:\ n \n* draft guidance “Content of Premarket Submissions for Device Softwa re Functions ”\ n \nDuring this webinar\, the FDA will provide highlights of this regulato ry document and will answer questions from webinar attendees.\n \n \nWebin ar Connection Details\nWe encourage you to join at least 15 minutes prior to the start of the webinar. You do not need to register to attend. We rec ommend you join using the Zoom link below\, if possible:\n \n* Webinar Lin k: https://fda.zoomgov.com/j/1611845469?pwd=YWl2UkdLdHVLNHFkT21kYlpORk1FQT 09 \n* Passcode: Ht8*kL\n \nIf you join by phone only without the Zoom lin k:\n* U.S. Callers Dial: 833 568 8864 (Toll Free) \n* International Caller s Dial: Please check the international numbers available \n \n* Webinar ID: 161 184 5469\n* Passcode: 468111 \n DTEND;TZID="Eastern Standard Time":20211216T140000 DTSTAMP:20211115T210837Z DTSTART;TZID="Eastern Standard Time":20211216T130000 LAST-MODIFIED:20211115T210837Z PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:FDA/CDRH Webinar - Content of Premarket Submissions for Device Software Functions\, Draft Guidance TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E00800000000D020302939DAD701000000000000000 0100000009F9736F3E582CA449269A7EDA7B01907 X-ALT-DESC;FMTTYPE=text/html:

Date/Time: December 16\, 2021 (Thursday)\, from 1 –\; 2 pm ET

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Background:

The U.S. Food and Dru g Administration (FDA)\, Center for Devices and Radiological Health (CDRH) \, will host a public webinar about:

 \;

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During this webinar\, the FDA will provide highl ights of this regulatory document and will answer questions from webinar a ttendees.

 \;

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Webinar Connection D etails

We encourage you to join at le ast 15 minutes prior to the start of the webinar. You do not need to regis ter to attend. We recommend you join using the Zoom link below\, if possib le:

 \;

  • Passcode: \;Ht8*kL

 \;

If you join by phone only without the Zoom link:

 \;

  • Webinar ID: 161 184 5469
  • Passcode: 468111
X-MICROSOFT-CDO-BUSYSTATUS:BUSY X-MICROSOFT-CDO-IMPORTANCE:1 X-MICROSOFT-DISALLOW-COUNTER:FALSE X-MS-OLK-CONFTYPE:0 BEGIN:VALARM TRIGGER:-PT15M ACTION:DISPLAY DESCRIPTION:Reminder END:VALARM END:VEVENT END:VCALENDAR