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:20230824T183322Z DESCRIPTION:Date: Thursday\, October 26\, 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 devic e manufacturers and other interested stakeholders to describe the FDA’s ongoing efforts to modernize the premarket notification [510(k)] Program\, and to provide an overview of three new draft guidances that the FDA beli eves will enhance the predictability\, consistency\, and transparency of 5 10(k) review. \n \nWebinar Connection Instructions\n* We encourage you t o join at least 15 minutes prior to the start of the webinar.\n* You do no t need to register to attend.\n* We recommend you join via the Zoom app us ing the Zoom link provided below. Listen through your computer speakers an d speak through your computer microphone/headset to ask a question. \n \n* Webinar Link: https://fda.zoomgov.com/j/1600235723?pwd=UXRXb2J6cHg2Tk5BL2 FsVUhheDZmdz09 \n* Passcode: TX1s&d\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 * +1 551 285 1373 US\n * +1 66 9 216 1590 US (San Jose)\n * +1 415 449 4000 US (US Spanish Line)\n* I nternational Callers Dial: Please check the international numbers availabl e \n \n* Webinar ID: 160 023 5723\n * Passcode: 214522\n \n DTEND;TZID="Eastern Standard Time":20231026T143000 DTSTAMP:20230824T183322Z DTSTART;TZID="Eastern Standard Time":20231026T130000 LAST-MODIFIED:20230824T183322Z LOCATION:Zoom PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:FDA/CDRH Webinar - CDRH’s Efforts to Continue to M odernize the 510(k) Program\, and New Draft Guidances TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E00800000000B0592FE33CC1D901000000000000000 010000000B683D19BEEA54A41BCF3BE38845B0BE1 X-ALT-DESC;FMTTYPE=text/html:< /head>

Date: Thursday\, October 26\, 2023

Time: 1 –\; 2:30 PM ET

 \;

Background:

The U.S. Food and Drug Administration (FDA)\, Center for Devic es and Radiological Health (CDRH)\, will host a public webinar for device manufacturers and other interested stakeh olders to describe the FDA’\;s ongoing efforts to modernize the prema rket notification [510(k)] Program\, and to provide an overview of three n ew draft guidances that the FDA believes will enhance the predictability\, consistency\, and transparency of 510(k) review.  \; \;

 \;

Webinar Connection Instructions

  • We encour age you to join at least 15 minutes prior to the start of the webinar.
  • You do not need to register to attend.< o:p>
  • We recommend you join via the Zoom app usi ng the Zoom link provided below. Listen through your computer speakers and speak through your computer microphone/headset to ask a question.

 \;

  • < span style='mso-bidi-font-family:Calibri'>Passcode: TX1s&\;d

 \;

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 locati on:
    •  \; \; \; +1 669 254 5252 US (S an Jose)
    •  \; \; \; +1 646 964 1167 US (US Spanish Line)
    •  \; \; \; +1 6 46 828 7666 US (New York)
    •  \; \; \; +1 551 285 1373 US
    •  \; \; \; +1 66 9 216 1590 US (San Jose)
    •  \; \; \; +1 415 449 4000 US (US Spanish Line)
  • International Callers Dial: Please check the international numbers availabl e

 \;

  • Webinar ID: 160 023 5723
  • Passcod e: 214522

 \;

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