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:20211115T211533Z DESCRIPTION:Date/Time: December 14\, 2021 (Tuesday)\, from 1 – 2 pm ET\n \nBackground:\nThe U.S. Food and Drug Administration (FDA)\, Center for De vices and Radiological Health (CDRH)\, will host a public webinar about:\n \n* De Novo Classification Process \, final guidance\n* FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock an d Goals \, final guidance\n \nDuring this webinar\, the FDA will provide highlights of these regulatory documents and will answer questions from webinar attendees.\n \n \nWebinar Connection Details\nWe en courage you 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 using the Zo om link below\, if possible:\n \n* Webinar Link: https://fda.zoomgov.com/j /1613967050?pwd=eWNXMVdpMjgzcXZLQVBlb0hFQktuQT09 \n* Passcode: h6RR@P\n \n If you join by phone only without the Zoom link:\n* U.S. Callers Dial: 833 568 8864 (Toll Free) \n* International Callers Dial: Please check the int ernational numbers available \n \n* Webinar ID: 161 396 7 050\n* Passcode: 468552\n \n DTEND;TZID="Eastern Standard Time":20211214T140000 DTSTAMP:20211115T211533Z DTSTART;TZID="Eastern Standard Time":20211214T130000 LAST-MODIFIED:20211115T211533Z PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:FDA/CDRH Webinar - De Novo Classification Process an d FDA and Industry Actions: Effect on FDA Review Clock and Goals\, final g uidances TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E00800000000409CF5303ADAD701000000000000000 010000000204807176AEF5F42BAEC456B917C640F X-ALT-DESC;FMTTYPE=text/html:

Date/Time : December 14\, 2021 (Tuesday)\, from 1 –\; 2 pm ET

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Background:

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

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During this webinar\, the FD A will provide highlights of these regulatory documents and will answer qu estions from webinar attendees.

 \;

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Webinar Connection Details

We encourage you to join at least 15 minutes prior to the start of the webinar. You do not need to register to attend. We recomm end you join using the Zoom link below\, if possible:

 \;

  • P asscode: \;h6RR@P

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If you join by phone only without the Zoom link:

 \;

  • Webinar ID: 161 396 7050
  • Pa sscode: \; 468552

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