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:20200406T175333Z DESCRIPTION:On April 16\, 2020\, the U.S. Food and Drug Administration (FDA ) will host a webinar for device manufacturers\, 3P510K Review Organizatio ns\, and industry to discuss and answer questions about the 510(k) Third P arty Review Program final guidance.\n \n \nBackground\nOn March 11\, 2020\ , the FDA issued final guidance: 510(k) Third Party Review Program . In addition\, the FDA is updating the list of devices eligible for review under the 510(k) Third Party Review Progr am. Through these actions\, the FDA has enhanced and strengthened the 510( k) Third Party Review Program for the benefit of the patient while the sta ndard for FDA's medical device review has been maintained.\n \nWebinar Det ails\nRegistration is not necessary.\nDate: April 16\, 2020\nTime: 1:00 PM - 2:30 PM\, ET\n\nTo ensure you are connected\, please dial-in 15 minutes prior to the start of the webinar.\nU.S. Callers Dial: \n* 888-233-1204 \ n* Conference number: PWXW1175627\n* Audience passcode: 7278970\n \nIntern ational Callers Dial:\n* 1-773-799-3794 \n* Conference number: P WXW1175627\n* Audience passcode: 7278970\n \nTo view the slide presentatio n during the webinar:\nhttps://www.mymeetings.com/nc/join.php?i=PWXW117562 7&p=7278970&t=c \n \nFollowing the webinar a transcript\, recording and sl ides will be available at: http://www.fda.gov/CDRHWebinar\n \nWe appreciat e your feedback on our webinar program. Following the webinar\, we will pr ovide a link to a short survey about your FDA CDRH webinar experience\, wh ich should take no more than 5-10 minutes to complete. Your responses are confidential and will be used to help ensure the quality of our webinar pr ogram.\n \nNote: The FDA does not provide Continuing Education Credits (CE U) or Certificates of Attendance for webinar attendance.\n \nTarget Audien ces: Industry (medical device companies or distributors\, technology manuf acturers (including start-up companies or labs)\, academic and research in stitutions\, healthcare facilities\, professional societies\, foundations and other non-profits\n \nIf you have any questions regarding this guidanc e document\, please contact CDRH's Division of Industry and Consumer Educa tion (DICE) at dice@fda.hhs.gov \, 1-800-638-204 1\, or 301-796-7100.\nFood and Drug Administration\nCenter for Devices and Radiological Health\n \n \n DTEND;TZID="Eastern Standard Time":20200416T143000 DTSTAMP:20200406T171404Z DTSTART;TZID="Eastern Standard Time":20200416T130000 LAST-MODIFIED:20200406T175333Z LOCATION:WebEx PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:FDA Webinar - 510(k) Third Party Review Program: Fin al Guidance TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E0080000000000FC310B150CD601000000000000000 01000000088A8BCD61150EA4E9EBEAA5A2D523282 X-ALT-DESC;FMTTYPE=text/html:

On April 16\, 2020\, the U.S. Food and Drug Administration (FDA) will host a webinar for device manufacturers\, 3P510K Review Organizations\, and in dustry to discuss and answer questions about the 510(k) Third Party Review Program final guidance.

 \;< /o:p>

 \;

Background

On March 11\, 202 0\, the FDA issued final guidance: 510(k) Third Party Review Prog ram. In addition\, the FDA is updating the list of devices eligible for review under the 510(k) Third Party Review Program. Thro ugh these actions\, the FDA has enhanced and strengthened the 510(k) Third Party Review Program for the benefit of the patient while the standard fo r FDA's medical device review has been maintained.

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Webinar Details

Registration is not necessary.
Date : \;April 16\, 2020
Time: \;1:00 PM - 2:30 PM\, ET
To ensure you are connected\, please dial-in 15 minutes prior to the start of the webinar.

U.S. Callers Di al: \;

  • 888-233-1 204
  • Conference number: PWXW1175627
  • Audience p asscode: 7278970

 \;

International Callers Dial:

  • 1-773-799-3794 \; \; \; \; \; \; \; \; \; \ ;
  • Conference number: PWXW1175627
  • Audie nce passcode: 7278970
  •  \;< /o:p>

    To view the slide presentation during the webi nar:
    https://www.mymeetings.com/nc/join.php?i=PWXW1175627& amp\;p=7278970&\;t=c

     \;

    Following the webinar a transcript\, recordin g and slides will be available at: http://www.fda.gov/CDRHWebinar

     \;

    We appreciate your feedback on our we binar program. Following the webinar\, we will provide a link to a short s urvey about your FDA CDRH webinar experience\, which should take no more t han 5-10 minutes to complete. Your responses are confidential and will be used to help ensure the quality of our webinar program.

     \;

    Note: The FDA does not provide Continuing Education Credits (CEU) or Certificates of Attenda nce for webinar attendance.

     \;< /o:p>

    Target Audiences: Industry (medical device com panies or distributors\, technology manufacturers (including start-up comp anies or labs)\, academic and research institutions\, healthcare facilitie s\, professional societies\, foundations and other non-profits< /p>

     \;

    If you have any questions regarding this guidance document\, please contact CDRH's Di vision of Industry and Consumer Education (DICE) at dice@fda.hhs.gov\, 1-800-638-2041\, or 301-796-7100.< /o:p>

    Food and Drug Administration
    Center for Dev ices and Radiological Health

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