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:20240628T181146Z DESCRIPTION:Date: Thursday\, August 22 \nTime: 1:00 PM – 2:30 PM ET\n \nB ackground:\nOn April 29\, 2024\, the U.S. Food and Drug Administration (FD A) announced a final rule amending the FDA's regulations to make explicit that IVDs are devices under the Federal Food\, Drug\, and Cosmetic Act (FD &C Act) including when the manufacturer of the IVD is a laboratory. Along with this amendment\, the FDA outlined a policy to phase out\, over the co urse of four years\, its general enforcement discretion approach to LDTs. \n \nOn August 22\, 2024\, the U.S. FDA will host a webinar for laborator y manufacturers and other interested stakeholders to discuss to comply wit h medical device reporting (MDR) requirements\, correction and removal rep orting requirements\, and quality system (QS) requirements regarding compl aint files beginning May 6\, 2025 (Stage 1 of the phaseout policy). \n \n Webinar Connection Instructions\n* We encourage you to join at least 15 mi nutes 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 pro vided below. Listen through your computer speakers and speak through your computer microphone/headset to ask a question. \n \n* Webinar Link: https: //fda.zoomgov.com/j/1616994355?pwd=cWZhS2RucTU4ZUNLbGF5ZFN5Wlo5dz09 \n* Pa sscode: %KeTf9\n \nIf you join by phone only 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 Yor k)\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 available \n \n* Webinar ID: 161 699 4355\n* Passcode: 066992\n \n DTEND;TZID="Eastern Standard Time":20240822T143000 DTSTAMP:20240628T181146Z DTSTART;TZID="Eastern Standard Time":20240822T130000 LAST-MODIFIED:20240628T181146Z LOCATION:Zoom PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:FDA/CDRH Webinar - MDR Requirements\, Correction and Removal Reporting Requirements\, and Quality System Complaint Requirement s for In Vitro Diagnostic Products (IVD) TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E00800000000009A8E0F63C9DA01000000000000000 0100000009FDA1FD3A5DB734982E5EA4522A34017 X-ALT-DESC;FMTTYPE=text/html:

< span style='mso-fareast-font-family:"Times New Roman"\;color:#333333'>Date : Thursday\, August 22

Time: 1:00 PM –\; 2:30 PM ET

 \ ;

Backgrou nd:

On April 29\, 2024\, the U.S. Food and Drug Administratio n (FDA) announced a final rule amending the FDA's regulations to make expl icit that IVDs are devices under the Federal Food\, Drug\, and Cosmetic Ac t (FD&\;C Act) including when the manufacturer of the IVD is a laborato ry. Along with this amendment\, the FDA outlined a policy to phase out\, o ver the course of four years\, its general enforcement discretion approach to LDTs. \; < /p>

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On August 22\, 2024\, the U.S. FDA will host a webinar for laborat ory manufacturers and other interested stakeholders to discuss to comply w ith medical device reporting (MDR) requirements\, correction and removal r eporting requirements\, and quality system (QS) requirements regarding com plaint files beginning May 6\, 2025 (Stage 1 of the phaseout policy). \;

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Webinar Connection Instructions

  • We encourage you to join at least 15 minutes prior to th e start of the webinar.< o:p>
  • You do not need to register to attend.
  • We recommend you join via the Z oom app using the Zoom link provided below. Listen through your computer s peakers and speak through your computer microphone/headset to ask a questi on.

 \;

  • Passcode : %KeTf9< /li>

 \;

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:
      • < li class=MsoListParagraph style='margin-left:-.25in\;mso-list:l0 level3 lf o3'>+1 669 254 5252 US (San Jose)
      • +1 646 964 1167 US ( US Spanish Line)
      • +1 646 828 7666 US (New York)
      • +1 669 216 1590 US (San Jose)
      • +1 415 449 4000 US (US Spanish Line)
      • +1 551 285 1373 US (New Jers ey)
  • International Callers Dial: Please check the international numbers av ailable

 \;

  • Webinar ID: 161 699 4355
  • Passcode: 066992< o:p>

 \;

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