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:20230322T203120Z DESCRIPTION:Date: Thursday\, April 13\, 2023 \nTime: 1 – 2:30 PM ET\n \nB ackground:\nThe U.S. Food and Drug Administration (FDA)\, Center for Devic es and Radiological Health (CDRH)\, will host a public webinar to share in formation and answer questions about the draft guidance\, Marketing Submis sion Recommendations for a Predetermined Change Control Plan for Artificia l Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions\ , that provides recommendations for content that should be included in a P redetermined Change Control Plan as part of a marketing submission for mac hine learning-enabled device software functions.\n \nWebinar Connection In structions\n* We encourage you to join at least 15 minutes prior to the st art of the webinar.\n* You do not need to register to attend.\n* We recomm end you join via the Zoom app using the Zoom link provided below. Listen t hrough your computer speakers and speak through your computer microphone/h eadset to ask a question. \n \n* Webinar Link: https://fda.zoomgov.com/j/1 617679339?pwd=bDJkbHVRY0NtRmlVSko5SkdpL3ZpUT09\n* Passcode: cC2Y@y\n \nIf you join by phone only without the Zoom link:\n* U.S. Callers Dial: 833-5 68-8864 (Toll Free)\n* International Callers Dial: Please check the intern ational numbers available \n \n* We binar ID: 161 767 9339\n* Passcode: 152020\n DTEND;TZID="Eastern Standard Time":20230413T143000 DTSTAMP:20230322T203120Z DTSTART;TZID="Eastern Standard Time":20230413T130000 LAST-MODIFIED:20230322T203120Z LOCATION:Zoom PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:CDRH Webinar - PCCP for AI/ML Enabled Medical Device s\, Draft Guidance TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E0080000000060A15F8BA047D901000000000000000 01000000013F3724478B4024E94684CED718FE19B X-ALT-DESC;FMTTYPE=text/html:

Date: Thursday\, April 13\, 2023

Time: 1 –\; 2:30 PM ET

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Background:

The U.S. Food and Drug Administration (F DA)\, Center for Devices and Radiological Health (CDRH)\, will host a publ ic webinar to share information and answer questions about the draft guida nce\, Marketing Submission Recommendations for a Predetermined Change Cont rol Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Devi ce Software Functions\, that provides recommendations for content that sho uld be included in a Predetermined Change Control Plan as part of a market ing submission for machine learning-enabled device software functions.< o:p>

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< span lang=EN style='mso-bidi-font-family:Calibri\;color:black\;mso-ansi-la nguage:EN'>Webinar Connection Instructions

  • W e encourage you to join at least 15 minutes prior to the start of the webi nar.
  • You do not need to register to attend.
  • We recommend you join via the Zoom app using the Zoom link provided below. Listen through your computer spea kers and speak through your computer microphone/headset to ask a question.

 \;

  • Passcode: cC2Y@y

 \;

If you join by phone only without the Zoom link:

 \;

  • Webinar ID: 161 767 9339
  • Passcode: 152020
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