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:20190927T152033Z DESCRIPTION:On November 14\, 2019\, the U.S. Food and Drug Administration ( FDA) will host a webinar for device manufacturers and industry to discuss and answer questions about the Changes to Existing Medical Software Polic ies Resulting from Section 3060 of the 21st Century Cures Act final guidance.\n \n \nBackground: Section 3060(a) of the 21st Centur y Cures Act (Cures Act) amended Section 520 of the Federal Food\, Drug\, a nd Cosmetic Act (FD&C Act) on December 13\, 2016\, removing certain softwa re functions from the definition of device in Section 201(h) of the FD&C A ct. This final guidance provides FDA's current thinking regarding the amen ded device definition and the resulting effect the amended definition has on the FDA's guidances related to medical device software. \n \nWebinar De tails: Registration is not necessary.\nDate: November 14\, 2019 \nTime: 2: 00 p.m. to 3:30 p.m. EST. To ensure you are connected\, please dial in 15 minutes prior to the start of the webinar.\nNOTE: You must dial-in to hea r the presentation and ask questions.\nU.S. Callers Dial:\n* 1- 888-780-96 49\n* Conference Number: PWXW9584733\n* Passcode: 2179630\nInternational C allers Dial:\n* 1-630-395-0306 \n* Conference Number: PWXW958473 3\n* Passcode: 2179630\n \nTo view the slide presentation during the webin ar: https://www.mymeetings.com/nc/join.php?i=PWXW9584733&p=2179630&t=c \nF ollowing the webinar\, a transcript\, recording and slides will be availab le at: http://www.fda.gov/CDRHWebinar\n \nWe appreciate your feedback on o ur webinar program. Following the webinar\, we will provide a link to a sh ort survey about your webinar experience\, which 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 CDRH webinar program.\n \nNOTE: The FDA does not provide Continuing Education (CEU) or Certificates of Attendance for webinar attendance.\nIf you have any questions\, please contact the D ivision of Industry and Consumer Education \n DTEND;TZID="Eastern Standard Time":20191114T153000 DTSTAMP:20190927T152033Z DTSTART;TZID="Eastern Standard Time":20191114T140000 LAST-MODIFIED:20190927T152033Z LOCATION:FDA PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:FDA Webinar- Changes to Existing Medical Software Po licies Resulting from Section 3060 of the 21st Century Cures Act: Final Gu idance TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E00800000000E0ACFF5B2575D501000000000000000 010000000E3478B65B5281D49A42045B2CB5C8E09 X-ALT-DESC;FMTTYPE=text/html:

On November 14\, 2019\, th e U.S. Food and Drug Administration (FDA) will host a webinar for device m anufacturers and industry to discuss \; and answer questions about the Changes to Existing Medical Software Policie s Resulting from Section 3060 of the 21st Century Cures Act fi nal guidance.

 \;

 \;

Background: Section 3060(a) of the 21s t Century Cures Act (Cures Act) amended Section 520 of the Federal Food\, Drug\, and Cosmetic Act (FD&\;C Act) on December 13\, 2016\, removing c ertain software functions from the definition of device in Section 201(h) of the FD&\;C Act. This final guidance provides FDA's current thinking regarding the amended device definition and the resulting effect the amend ed definition has on the FDA's guidances related to medical device softwar e.

 \;

Webinar Details:& nbsp\;Registration is not necessary.

Date: \;November 14\, 2019

Time: 2:00 p.m. to 3:30 p.m. EST.  \; To ensure you are connected\ , please dial in 15 minutes prior to the start of the webinar.< /p>

NOTE: You must dial-in to hear the presentation and ask questions.

U.S. Callers Dial:

  • 1- 888-780-9649
  • Conference Number: PWXW95 84733
  • Passcode: 2179630

International Callers Dial:

  • 1-630-395-0306 \; \;& nbsp\; \; \; \; \; \; \; \;
  • Conference Number: PWXW9584733
  • Passcode: 2179630

 \;

T o view the slide presentation during the webinar: https://www .mymeetings.com/nc/join.php?i=PWXW9584733&\;p=2179630&\;t=c

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

 \;< /p>

We appreciate your feedback on our webinar program. Following the webinar\, we will pro vide a link to a short survey about your webinar experience\, which should take no more than 5-10 minutes to complete. Your responses are confidenti al and will be used to help ensure the quality of our CDRH webinar program .

 \;

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

If you have any questions\, please \;contact th e Division of Industry and Consumer Education

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