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:20190919T153757Z DESCRIPTION:On October 28\, 2019\, the FDA will host a webinar for industry \, accreditation bodies\, testing laboratories and standards developing or ganizations to discuss and answer questions about the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program Draft Guidance published on Septembe r 20\, 2019. \n \nBackground: The ASCA Pilot is intended to support the FD A’s public health mission by providing increased confidence in testing f rom ASCA-accredited testing laboratories\, as well as potentially decreasi ng the burden of individual premarket submissions when manufacturers rely on testing completed by ASCA-accredited testing laboratories. \nThe overar ching goals of the ASCA Pilot are to:\n* Enhance confidence in medical dev ice testing\n* Promote consistency and predictability in the premarket rev iew process\n* Encourage effective use of the FDA’s resources\n* Enhance regulatory efficiency\n* Support international harmonization\n \nThis web inar will provide details about the draft guidance and offer an opportunit y for webinar participants to ask questions about the draft guidance. \n \nWebinar Details:\n \nRegistration is not necessary.\n \nDate: Monday\, O ctober 28\, 2019\nTime: 12:00 PM ET – 1:30 PM ET\nTo ensure you are conn ected\, please dial-in 15 minutes prior to the start of the webinar.\n \nU .S. Callers Dial:\n* 800-779-1636\n* Conference Number: PWXW9431166 \n* Pa sscode: 4106490\n \nInternational Callers Dial:\n* 1-773-756-0108\n* Confe rence Number: PWXW9431166\n* Passcode: 4106490\n \nTo view the slide prese ntation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW9 431166&p=4106490&t=c\n \nFollowing the webinar\, a transcript\, recording and slides will be available at:\nhttp://www.fda.gov/CDRHWebinar\n \nWe ap preciate your feedback on our webinar program. Following the webinar\, we will provide a link to a short survey about your FDA CDRH webinar experien ce\, which should take no more than 5-10 minutes to complete. Your respons es are confidential and will be used to help ensure the quality of our web inar program. \n \nNote: The FDA does not provide Continuing Education Cre dits (CEU) or Certificates of Attendance for webinar attendance.\n \nTarge t Audiences: Industry (technology manufacturers (including start-up compan ies or labs)\, accreditation bodies\, testing laboratories\, FDA staff\, s tandards organizations\, academic and research institutions\, health care facilities\, professional societies\, foundations and other non-profits.\n \nIf you have any questions regarding this draft guidance document\, plea se contact us at ASCA@fda.hhs.gov . \n \n DTEND;TZID="Eastern Standard Time":20191028T133000 DTSTAMP:20190919T153757Z DTSTART;TZID="Eastern Standard Time":20191028T120000 LAST-MODIFIED:20190919T153757Z LOCATION:FDA PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:FDA Webinar- Accreditation Scheme for Conformity Ass essment (ASCA) Pilot Program: Draft Guidance TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E00800000000701B75DB3F49D501000000000000000 01000000099D24BF5E5F7814F91BF9AF07D685164 X-ALT-DESC;FMTTYPE=text/html:

On October 28\, 2019\, the FDA will host a webinar for industr y\, accreditation bodies\, testing laboratories and standards developing organizations to discuss and answer questions about the Accreditation Scheme for Conformity Assessm ent (ASCA) Pilot Program Draft Guidance published on September 20\, 2019.

 \;

Background: The ASCA Pilot is intended to supp ort the FDA’\;s public health mission by providing increased confiden ce in testing from ASCA-accredited testing laboratories\, as well as poten tially decreasing the burden of individual premarket submissions when manu facturers rely on testing completed by ASCA-accredited testing laboratorie s.

The overarching goals of the ASCA Pilot are to:

  • Enhance confidence in medical device testi ng
  • Promote consistency and predictability in the premarket review process
  • En courage effective use of the FDA’\;s resources
  • Enhance regulatory effi ciency
  • Support international harmonization

&n bsp\;

This webinar will provide details about the draft guid ance and offer an opportunity for webinar participants to ask questions ab out the draft guidance. \;

 \;< /b>

Webinar Details:

 \;< /p>

Registration is not necessary.

&n bsp\;

Date: \;Monday\, Oct ober 28\, 2019
Time: 12:00 PM ET –\; 1:30 PM ET
To ensure you a re connected\, please dial-in 15 minutes prior to the start of the webinar .

 \;

U.S. Callers Dial:< span lang=EN style='mso-bidi-font-family:"Times New Roman"\;mso-ansi-langu age:EN'>

  • 800-779-1636
  • Conference Number: PWXW9431166
  • Passcode: 41064 90

 \;< /o:p>

International Callers D ial:

  • 1-773-756-0108
  • Conference N umber: PWXW9431166
  • Passcode: 4106490

 \;

To view the slide presentatio n during the webinar: https://www.mymeetings.com/nc/join.p hp?i=PWXW9431166&\;p=4106490&\;t=c

 \;

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

 \;

< b>We appreciate your feedback on our webinar program. Followin g the webinar\, we will provide a link to a short survey about your FDA CD RH webinar experience\, which should take no more than 5-10 minutes to com plete. Your responses are confidential and will be used to help ensure the quality of our webinar program.

 \;

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

 \;

Target Audiences: Industry (technology manufacturers ( including start-up companies or labs)\, accreditation bodies\ , testing laboratories\, FDA staff\, standards organizations\, academic and research institutions\, health care facilities\, profess ional societies\, foundations and other non-profits.

 \;

If you have any questions regarding this draft guidance documen t\, please contact us at ASCA@fda.hhs .gov.

 \;

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