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:20231107T193321Z DESCRIPTION:Date: Thursday\, January 11\, 2024 \nTime: 1 – 2:00 PM ET\n \ nBackground:\nThe U.S. Food and Drug Administration (FDA)\, Center for Dev ices and Radiological Health (CDRH)\, will host a public webinar for indus try and other interested stakeholders to discuss the final guidance\, Asse ssing the Credibility of Computational Modeling and Simulation in Medical Device Submissions. The guidance provides a general framework for how the FDA will assess computational modeling and simulation (CM&S) credibility i n medical device regulatory submissions. It also provides FDA recommendati ons on factors manufacturers should consider when providing CM&S in regula tory submissions.\n \nWebinar Connection Instructions\n* We encourage you to join at least 15 minutes prior to the start of the webinar.\n* You do n ot need to register to attend.\n* We recommend you join via the Zoom app u sing the Zoom link provided below. Listen through your computer speakers a nd speak through your computer microphone/headset to ask a question. \n \n * Webinar Link: https://fda.zoomgov.com/j/1609132203?pwd=bWJBc3JkR2dCNENhR mNGbTU5ZUEwUT09 \n* Passcode: Xc=5$R\n \nIf you join by phone only without the Zoom link:\n* U.S. Callers Dial: 833-568-8864 (Toll Free)\n * For hi gher quality\, dial a number based on your current location:\n * +1 66 9 254 5252 US (San Jose)\n * +1 646 964 1167 US (US Spanish Line)\n * +1 646 828 7666 US (New York)\n * +1 415 449 4000 US (US Spanish L ine)\n * +1 551 285 1373 US\n * +1 669 216 1590 US (San Jose)\n* I nternational Callers Dial: Please check the international numbers availabl e \n \n* Webinar ID: 160 913 2203\n* Passcode: 162533\n \n \n DTEND;TZID="Eastern Standard Time":20240111T140000 DTSTAMP:20231107T193321Z DTSTART;TZID="Eastern Standard Time":20240111T130000 LAST-MODIFIED:20231107T193321Z LOCATION:Zoom PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:FDA/CDRH Webinar - Assessing the Credibility of Comp utational Modeling and Simulation in Medical Device Submissions\, Final Gu idance TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E00800000000A03471024ABAD901000000000000000 0100000003CEE8F9B689B6F4CA96036AA413CA37B X-ALT-DESC;FMTTYPE=text/html:< !--[if gte mso 10]>

Date: Thursday\, January 11\, 2024

Time: 1 –\; 2:00 PM ET

 \ ;

Backgrou nd:

< span style='mso-fareast-font-family:"Times New Roman"\;color:#333333'>The U.S. Food and Drug Administration (FDA)\, Center for Devices and Radiologi cal Health (CDRH)\, will host a public webinar for industry and other inte rested stakeholders to discuss the final guidance\, Assessing the Credibil ity of Computational Modeling and Simulation in Medical Device Submissions . The guidance provides a general framework for how the FDA will assess co mputational modeling and simulation (CM&\;S) credibility in medical dev ice regulatory submissions. It also provides FDA recommendations on factor s manufacturers should consider when providing CM&\;S in regulatory sub missions.

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Webinar Connection Instructions< /span>

  • We encourage you to join at least 15 minutes prior to t he start of the webinar.
  • 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 speakers and speak through your computer microphone/headset to ask a quest ion.

 \;

  • Passcode: Xc=5$ R

 \;

If you join by phone only without the Zoom link:

  • U.S. Callers Dial: \; 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)
    •  \; \; \; +1 415 449 4000 US (US Spanish Line)
    •  \;&n bsp\; \; +1 551 285 1373 US
    •  \; \; \; +1 669 216 1590 US (San Jose)
  • International Caller s Dial: Please che ck the international numbers available

 \;

  • Webinar ID: 160 913 2203
  • P asscode: 162533

 \;

&nbs p\;

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