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:20190911T163252Z DESCRIPTION:On October 31\, 2019\, the U.S. Food and Drug Administration (F DA) will host a webinar for device manufacturers and industry to discuss a nd answer questions about the Special 510(k) Program Final Guidance . \n \nBackground: On September 12\, 2019\, the FDA issue d a final guidance document on the Special 510(k) Program. \n“The New 51 0(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalen ce in Premarket Notifications” guidance is superseded by this final guid ance document and The Abbreviated 510(k) Program \, which reflects the Abbreviated 510(k) information from the New 510(k) Paradigm guidance. \nThe FDA also updated the following final guidance doc uments to reflect the updated Special 510(k) Program\, improve alignment b etween the related 510(k) guidance\, and reflect current policies:\n* Form at for Traditional and Abbreviated (510(k)s) \n* Refuse to Accept Policy for 510(k)s \n \nTogether\, these guidance documents provide consistency\, cla rity and transparency to industry and the FDA and may conserve resources f or both\, while still protecting public health\, and not altering the stat utory criteria for substantial equivalence.\n \nWebinar Details:\n \nRegis tration is not necessary.\n \nDate: Thursday\, October 31\, 2019\nTime: 1: 00 PM – 2:30 PM\, EDT\nTo ensure you are connected\, please dial-in 15 m inutes prior to the start of the webinar.\n \nU.S. Callers Dial:\n* 888-39 0-1068\n* Conference Number: PWXW9502204 \n* Passcode: 6352340\nInternatio nal Callers Dial:\n* 1-212-547-0152\n* Conference Number: PWXW9502204\n* P asscode: 6352340\n \nTo view the slide presentation during the webinar: ht tps://www.mymeetings.com/nc/join.php?i=PWXW9502204&p=6352340&t=c\n\n\nFoll owing the webinar\, a transcript\, recording and slides will be available at:\nhttp://www.fda.gov/CDRHWebinar\n \nWe appreciate your feedback on our webinar program. Following the webinar\, we will provide a link to a shor t survey about your FDA CDRH webinar experience\, which should take no mor e than 5-10 minutes to complete. Your responses are confidential and will be used to help ensure the quality of our webinar program. \n \nNote: The FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendance for webinar attendance.\n \nTarget Audiences: Industry\, third party review organizations\, technology manufacturers (including start-up companies or labs)\, academic and research institutions\, health care fac ilities\, professional societies\, foundations and other non-profits. \n \ nIf you have any questions regarding this final guidance document\, please contact CDRH’s Division of Industry and Consumer Education (DICE) at di ce@fda.hhs.gov \, 1-800-638-2041\, or 301-796-71 00.\n \n DTEND;TZID="Eastern Standard Time":20191031T143000 DTSTAMP:20190911T163252Z DTSTART;TZID="Eastern Standard Time":20191031T130000 LAST-MODIFIED:20190911T163252Z LOCATION:FDA PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:FDA Webinar: Special 510 (K) Program TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E00800000000D0C68717C35CD501000000000000000 010000000BD808B4FEEAC6E439009851AD29DB1EF X-ALT-DESC;FMTTYPE=text/html:

< span lang=EN style='mso-ansi-language:EN'>On October 31\, 2019\, the U.S. Food and Drug Administration (FDA) will host a webinar for device manufacturers and industry to di scuss and answer questions about the Special 510(k) Program Final Guidance.  \;

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Background: On September 12\, 2019\, the FDA issued a final guidance docum ent on the Special 510(k) Program.

̶ 0\;The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substant ial Equivalence in Premarket Notifications”\; guidance is superseded by this final guidance document and T he Abbreviated 510(k) Program\, which reflects the Abbreviated 510 (k) information from the New 510(k) Paradigm guidance.

The FDA also updated the following final gu idance documents to reflect the updated Special 510(k) Program\, improve a lignment between the related 510(k) guidance\, and reflect current policie s:

 \;

Tog ether\, these guidance documents provide consistency\, clarity and transpa rency to industry and the FDA and may conserve resources for both\, while still protecting public health\, and not altering the statutory criteria f or substantial equivalence.

 \;

Webinar Details:< o:p>

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Registration is not nece ssary.

 \;

Date: \;Thursday\, October 31\, 2019
Time: 1:00 PM –\; 2:30 PM\, EDT
To ensure you are connected\, please dial-in 15 minutes prior to the start of the webinar.

 \;

U.S. Callers Dial:

  • 888-390-1068
  • Conference Number: PWXW9502204
  • Passcode: 6352340< o:p>

International Callers Dial:

  • 1-212-547-0152
  • Conference Number : PWXW9502204
  • Passcode: 6352340

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To view the slide presentation during t he webinar: https://www.mymeetings.com/nc/join.php?i=PWXW9 502204&\;p=6352340&\;t=c

Following the webinar\, a transcript\, recording and slides will be avail able at:
http://www.fda.gov/CD RHWebinar

 \;

We appreciate your feedback on our webinar program. Following the webinar\, we will prov ide a link to a short survey about your FDA CDRH webinar experience\, whic h should take no more than 5-10 minutes to complete. Your responses are co nfidential and will be used to help ensure the quality of our webinar prog ram.

< o:p> \;

Note: The FDA does not provide Continuing Education Credit s (CEU) or Certificates of Attendance for webinar attendance.

 \;

Target Audiences: Industry\, third party review organization s\, technology manufacturers (including start-up companies or labs)\, acad emic and research institutions\, health care facilities\, professional soc ieties\, foundations and other non-profits.

 \;

If you have any questions regarding this final guidance document\, please con tact CDRH’\;s Division of Industry and Consumer Education (DICE) at < a href="mailto:dice@fda.hhs.gov">dice@fda.hhs.gov\, 1-800-638-2041\, o r 301-796-7100.

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