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:20240510T172602Z DESCRIPTION:Date: Wednesday\, June 5 \nTime: 1:00 PM – 2:00 PM ET\n \nBac kground:\nThe U.S. Food and Drug Administration (FDA) will host a webinar to provide an overview of the two draft guidances: Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response i n the Absence of a Declaration under Section 564  and Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency .\n \nWebinar Connection Instructions\n* We enco urage 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 Zoom link provided below. Listen through your computer speakers and speak through your computer microphone/headset to ask a quest ion. \n \n* Webinar Link: https://fda.zoomgov.com/j/1616994355?pwd=cWZhS2R ucTU4ZUNLbGF5ZFN5Wlo5dz09 \n* Passcode: %KeTf9\n \nIf you join by phone on ly without the Zoom link:\n* U.S. Callers Dial: 833-568-8864 (Toll Free)\ n * For higher quality\, dial a number based on your current location:\n * +1 669 254 5252 US (San Jose)\n * +1 646 964 1167 US (US Spanish Line)\ n * +1 646 828 7666 US (New York)\n * +1 669 216 1590 US (San Jose)\n * +1 415 449 4000 US (US Spanish Line)\n * +1 551 285 1373 US (New Jersey) \n* International Callers Dial: Please check the international numbers ava ilable \n \n* Webinar ID: 161 699 4 355\n* Passcode: 066992\n \n DTEND;TZID="Eastern Standard Time":20240605T140000 DTSTAMP:20240510T172602Z DTSTART;TZID="Eastern Standard Time":20240605T130000 LAST-MODIFIED:20240510T172602Z LOCATION:Zoom PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:FDA/CDRH Webinar - Enforcement Policies for Tests – Draft Guidances TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E00800000000604BDE28DDA2DA01000000000000000 010000000FF9868175F94F44B832E5D5D366AD50C X-ALT-DESC;FMTTYPE=text/html:\n

Date: Wednesd ay\, June 5

Time: 1:00 PM – 2:00 PM ET

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Background:

The U.S . Food and Drug Administration (FDA) will host a webinar to provide an ove rview of the two draft guidances: \;Enforcement Policy for Certain In Vitro Diagnostic Devices fo r Immediate Public Health Response in the Absence of a Declaration under S ection 564  \;and Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency.

&nbs p\;

Webinar Connection Instructions< /b>

  • We encourage you to join at least 15 minutes prior to the star t of the webinar.
  • You do not need to register to attend.
  • We recommend you join via the Zoom ap p using the Zoom link provided below. Listen through your computer speaker s and speak through your computer microphone/headset to ask a question.

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