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:20200911T161334Z DESCRIPTION:Summary: \nOn October 15\, 2020\, the FDA will host a webinar f or the medical device industry and other stakeholders to discuss and answe r questions about the final guidance Recognition and Withdrawal of Volunta ry Consensus Standards . \nBackground:\nOn September 14\, 2020\, the FDA issued the fina l guidance: Recognition and Withdrawal of Voluntary Consensus Standards. T his final guidance explains the updated procedures the FDA intends to foll ow when the FDA receives requests for recognition of consensus standards a nd withdraws recognition of a consensus standard.\nIn summary\, the FDA:\n * Will publish its justification for recognition and non-recognition decis ions\n* May\, when appropriate\, determine a transition time for revised s tandards\n* Intends to respond to all recognition requests within 60 days\ n* Will periodically update the Recognized Standards Database with pend ing recognitions. As soon as FDA makes a determination to recognize a stan dard and it appears in the recognition database\, manufacturers may cite t hem in premarket submissions\; manufacturers will no longer have to wait f or the publication of a Federal Register notice\n \nWebinar Details:\nRegi stration is not necessary.\nDate: October 15\, 2020\nTime: 1:00 PM-2:30 PM Eastern Time\n\n\nTo ensure you are connected\, please dial-in 15 minutes before the start of the webinar\nNOTE: You must dial-in to hear the prese ntation and ask questions:\nU.S. Callers Dial: 888-455-1392\nCONFERENCE NU MBER: PWXW1679449\nPASSCODE: 5230025\nInternational Callers Dial: 1-773-7 99-3847 \nCONFERENCE NUMBER: PWXW1679449\nPASSCODE: 5230025\nTo view the slide presentation during the webinar: \nhttps://www.mymeetings.c om/nc/join.php?i=PWXW1679449&p=5230025&t=c\n \nFollowing the webinar\, a t ranscript\, recording and slides will be available at: http://www.fda.gov/ CDRHWebinar \nWe appreciate your feedback on our webinar program. After th e webinar\, we will provide a link to a short survey about your experience \, which should take no more than 5-10 minutes to complete. Your responses are confidential and will be used to improve the quality of our webinar p rogram.\nNOTE: The FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendance.\n \n \n DTEND;TZID="Eastern Standard Time":20201015T143000 DTSTAMP:20200911T161334Z DTSTART;TZID="Eastern Standard Time":20201015T130000 LAST-MODIFIED:20200911T161334Z LOCATION:WebEx PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:FDA Webinar: Recognition and Withdrawal of Voluntary Consensus Standards Final Guidance TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E00800000000706E634C3488D601000000000000000 01000000034F0BBD7801F88429164919C72025919 X-ALT-DESC;FMTTYPE=text/html:

Summa ry:

On October 15\, 2020\, the FDA w ill host a webinar for the medical device industry and other stakeholders to discuss and answer questions about the final guidance Rec ognition and Withdrawal of Voluntary Consensus Standards .  \; \;

Background:

On September 14\, 202 0\, the FDA issued the final guidance: Recognition and Withdrawal of Volun tary Consensus Standards. This final guidance explains the updated procedu res the FDA intends to follow when the FDA receives requests for recogniti on of consensus standards and withdraws recognition of a consensus standar d.

In summary\, the FDA:

  • Will publish its justification for recognition a nd non-recognition decisions
  • May\, when appropriate\, determine a transition time for revised standards
  • Intends to respond to all recognition requests within 60 days
  • Will periodically update the Recognized Standards Database with pending recognitions. As soon as FDA makes a d etermination to recognize a standard and it appears in the recognition dat abase\, manufacturers may cite them in premarket submissions\; manufacture rs will no longer have to wait for the publication of a Federal Register notice

 \;

Webinar Details:< /b>

Registration is not necessary.

Date: October 15\, 2020
Time: 1:00 PM-2:30 PM Eastern Time

To ensure you are connected\, please dial-in 15 minutes before the star t of the webinar

< p class=MsoNormal>NOTE: You must dial-in to hear the presentation and ask questions:

U.S. Callers Dial: \;888-455-1392
CONFERENC E NUMBER: PWXW1679449
PASSCODE: 5230025

International Callers Dial: \; 1-773-799-3847 \; \; \;  \; \; \; \; \; \; \;
CONFERENCE NU MBER: PWXW1679449
PASSCODE: 5230025

To view the slide presentation during the webinar: \;

https://www.mymeetings.com/nc/join.php?i=PWXW1 679449&\;p=5230025&\;t=c

& nbsp\;

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

We appreciate your feedback on our webinar program. After the w ebinar\, we will provide a link to a short survey about your experience\, which should take no more than 5-10 minutes to complete. Your responses ar e confidential and will be used to improve the quality of our webinar prog ram.

NOTE: The FDA does not provi de Continuing Education Credits (CEU) or Certificates of Attendance.< /o:p>

 \;

 \;

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