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:20210104T211605Z DESCRIPTION:Summary: On Monday\, Feburary 1\, 2021\, the FDA will host a we binar on the Safer Technologies Program for industry and other stakeholder s interested in learning more about the Program and final guidance .\nBackground: : The U.S. Fo od and Drug Administration (FDA) issued a final guidance outlining the Safer Technologies Prog ram for Medical Devices . This program is a voluntary pathway for certain medical devices and device-led combination products that are reasonably expected to significan tly improve the safety of currently available treatments or diagnostics fo r diseases or conditions that are less serious than those eligible for the Breakthrough Devices Program .\nWe rec ognize and anticipate that the FDA may need up to 60 days to operationaliz e the Safer Technologies Program following issuance of the final guidance. The FDA does not intend to accept requests for inclusion in the program w ithin this time period. We anticipate accepting program entrance requests beginning on March 8\, 2021.\n\nWebinar Details:\n\nRegistration is not ne cessary.\nDate: February 1\, 2021\nTime: 12:00 PM - 1:30 PM\, ET\n\nTo ens ure you are connected\, please dial-in 15 minutes prior to the start of th e webinar.\nU.S. Callers Dial:\n* 888-455-1392\n* Conference Number: PWXW1 929130\n* Passcode: 5640600\nInternational Callers Dial:\n* 1-773-799-3847 \n* Conference Number: PWXW1929130\n* Passcode: 5640600\nTo view the slide presentation during the webinar:\nhttps://www.mymeetings.com/nc/join.php? i=PWXW1929130&p=5640600&t=c\nFollowing the webinar\, a transcript\, record ing\, and slides will be posted below.\nWe appreciate your feedback on our webinar program. Following the webinar\, we will provide a link to a shor t survey about the webinar experience. The survey should take no more tha n 5-10 minutes to complete. Your responses are confidential and will be us ed to help ensure the quality of our webinar program.\nNote: The FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendan ce for webinar attendance.\n \n DTEND;TZID="Eastern Standard Time":20210201T133000 DTSTAMP:20210104T211605Z DTSTART;TZID="Eastern Standard Time":20210201T120000 LAST-MODIFIED:20210104T211605Z LOCATION:Webinar PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:Webinar: Safer Technologies Program for Medical Dev ices TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E00800000000802CA999B4E2D601000000000000000 010000000672175912905FE4C861ECA2E4ADDE989 X-ALT-DESC;FMTTYPE=text/html:

Summary: On Monday\, Feburary 1\, 2021\, the FDA will host a webinar on the Safer Technologies Program for industry an d other stakeholders interested in learning more about the Program and final guidance.

Background: : The U.S. Food and Drug Administration (FDA) issued a final guidance outlining the Safer T echnologies Program for Medical Devices. This program is a voluntary p athway for certain medical devices and device-led combination products tha t are reasonably expected to significantly improve the safety of currently available treatments or diagnostics for diseases or conditions that are l ess serious than those eligible for the Breakthrough Devices Program .

We recognize and anticipate that the FDA m ay need up to 60 days to operationalize the Safer Technologies Program fol lowing issuance of the final guidance. The FDA does not intend to accept r equests for inclusion in the program within this time period. We anticipat e accepting program entrance requests beginning on March 8\, 2021.

Webinar Details:< span lang=EN style='mso-fareast-font-family:"Times New Roman"\;color:#3333 33\;mso-ansi-language:EN'>

Registration is not necessa ry.

Date: February 1\, 2021
Time: 12:00 PM - 1:30 PM\, ET

To ensure you are connected\, please dial-in 15 minutes prior to the start of the webinar.

U.S. Callers Dial:

    < li class=MsoNormal style='color:#333333\;mso-margin-top-alt:auto\;mso-marg in-bottom-alt:auto\;mso-list:l1 level1 lfo1\;tab-stops:list .5in'>888-455-1392
  • Conferen ce Number: PWXW1929130
  • Passcode: 5640600

Intern ational Callers Dial:

  • 1-773-799-3847< /o:p>
  • Conf erence Number: PWXW1929130
  • Passcode: 5640600
< p style='margin-bottom:0in\;margin-bottom:.0001pt'>To view the slide pre sentation during the webinar:
https://www.mymeetings.com/n c/join.php?i=PWXW1929130&\;p=5640600&\;t=c

Following the webinar\, a transcript\, recording\, and slides will be posted below.

We appreciate your feedback on our webin ar program. Following the webinar\, we will provide a link to a short surv ey about the webinar experience. \; The survey should take no more tha n 5-10 minutes to complete. Your responses are confidential and will be us ed to help ensure the quality of our webinar program.

Note: The FDA does not provide Continuing Educatio n Credits (CEU) or Certificates of Attendance for webinar attendance.

 \;

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