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:20230719T160147Z DESCRIPTION:Date: Thursday\, October 12\, 2023 \nTime: 1 – 2:30 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\, Use of International Standard ISO 10993-1\, “Biological evaluation of medica l devices – Part 1: Evaluation and testing within a risk management proc ess.”\n \nWebinar Connection Instructions\n* We encourage you to join at least 15 minutes prior to the start of the webinar.\n* You do not need to register to attend.\n* We recommend you join via the Zoom app using the Z oom link provided below. Listen through your computer speakers and speak t hrough your computer microphone/headset to ask a question. \n \n* Webinar Link: https://fda.zoomgov.com/j/1604587100?pwd=RFVjVjhqRmRuQm1uZmd6aDhGb0t PQT09 \n* Passcode: fp.4Q!\n \nIf you join by phone only without the Zoom link:\n* U.S. Callers Dial: 833-568-8864 (Toll Free)\n * For higher qual ity\, dial a number based on your current location:\n * +1 669 254 525 2 US (San Jose)\n * +1 646 964 1167 US (US Spanish Line)\n * +1 64 6 828 7666 US (New York)\n * +1 551 285 1373 US\n * +1 669 216 159 0 US (San Jose)\n * +1 415 449 4000 US (US Spanish Line)\n* Internatio nal Callers Dial: Please check the international numbers available \n \n* Webinar ID: 160 458 7100\n* Passcod e: 930120\n \n DTEND;TZID="Eastern Standard Time":20231012T143000 DTSTAMP:20230719T160147Z DTSTART;TZID="Eastern Standard Time":20231012T130000 LAST-MODIFIED:20230719T160147Z LOCATION:Zoom PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:FDA/CDRH Webinar - Use of International Standard ISO 10993-1\, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"\, Final Guidance TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E00800000000F06C592638BAD901000000000000000 010000000B877F3B62D874A43AA2FEADB640E7311 X-ALT-DESC;FMTTYPE=text/html:

Dat e: Thursday\, October 12\, 2023 < o:p>

Time: 1  211\; 2:30 PM ET

 \;

Bac kground:

The U.S. Food and Drug Administration (FDA) \, Center for Devices and Radiological Health (CDRH)\, will host a public webinar for industry and other interested stakeholders to discuss the fina l guidance\, Use of International Standard ISO 10993-1\, “\;Biologica l evaluation of medical devices –\; Part 1: Evaluation and testing wi thin a risk management process.”\;

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Webinar Connection Instruct ions

  • We encourage you to join at least 15 mi nutes prior to the 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 belo w. Listen through your computer speakers and speak through your computer m icrophone/headset to ask a question.

 \;

  • Passcode : fp.4Q!
  •  \;

    If you join by phone only with out the Zoom link:

    • U.S. Callers Dial: \; 833 -568-8864 (Toll Free)
      • For higher quality\, dia l a number based on your current location:
      •  \;&nbs p\; \; +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 1590 US (San Jose)
      •  \; \; \; +1 415 449 4000 US (US Spanish Line )
    • International Callers Dial: Please c heck the international numbers available

     \;

    • Webinar ID: 160 458 7100< o:p>
    • Passcode: 930120< o:p>

     \;

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