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:20190906T122359Z DESCRIPTION:On Monday\, October 21\, 2019\, the FDA will host a webinar for device manufacturers and industry to discuss and answer questions about t he Humanitarian Device Exemption Program Final Guidance published on September 5\, 2019. \n \nThis final guidance describes how the FDA determines whether to approve a humanitari an device exemption application for a device that is meant to treat or dia gnose populations with uncommon medical conditions.\n* This final guidance supersedes “Guidance for HDE Holders\, Institutional Review Boards (IRB s)\, Clinical Investigators\, and Food and Drug Administration Staff\, Hum anitarian Device Exemptions (HDE) Regulation: Questions and Answers” iss ued July 8\, 2010.\n* This guidance provides clarity to industry and FDA s taff about current review practices for the Humanitarian Device Exemption (HDE) Program. \n* This guidance explains updates to the size of the patie nt population and the changes in review committee requirements.\n \nWebina r Details:\nRegistration is not necessary.\nDate: October 21\, 2019\nTime: 12:00 PM – 1:30 PM\, EDT\n\n\nTo ensure you are connected\, please dial -in 15 minutes prior to the start of the webinar.\n \nU.S. Callers Dial:\n * 800-369-3163\n* Conference Number: PWXW9442225 \n* Passcode: 3000516\nIn ternational Callers Dial:\n* 1-773-756-4627\n* Conference Number: PWXW9442 225\n* Passcode: 3000516\n \nTo view the slide presentation during the web inar: \ n\n\nFollowing the webinar\, a transcript\, recording and slides will be a vailable at:\n\n \n \nWe appreciate your fee dback on our webinar program. Following the webinar\, we will provide a li nk to a short survey about your FDA CDRH 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 webinar program. \n \nNote: The FDA does not provide Continuing Education Credits (CEU) or Cer tificates of Attendance for webinar attendance.\n \nTarget Audiences: Indu stry\, technology manufacturers (including start-up companies or labs)\, a cademic and research institutions\, health care facilities\, professional societies\, foundations and other non-profits \nIf you have any questions about this guidance document\, please contact CDRH’s Division of Industr y and Consumer Education (DICE) at \, 1-800-638-2041\, or 301-796-7100.\n \n DTEND;TZID="Eastern Standard Time":20191021T133000 DTSTAMP:20190905T213000Z DTSTART;TZID="Eastern Standard Time":20191021T120000 LAST-MODIFIED:20190906T122359Z LOCATION:FDA PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:FDA Webinar- Humanitarian Device Exemption Program F inal Guidance TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E00800000000C0EFDF2CA84BD501000000000000000 01000000063176D8878A8C64995D1CB63E4501230 X-ALT-DESC;FMTTYPE=text/html: