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:20200923T180511Z DESCRIPTION:Summary: \nOn October 22\, 2020\, the FDA will host a webinar f or the medical device industry and other stakeholders to discuss and answe r questions about three final guidance documents related to the Accreditat ion Scheme for Conformity Assessment Pilot Program (ASCA Pilot): Program G uidance\, Basic Safety and Essential Performance Standard-specific Guidanc e\, and Biocompatibility Standard-specific Guidance\n \nBackground:\nThe U .S. Food and Drug Administration (FDA) issued three final guidance documen ts related to the Accreditation Scheme for Conformity Assessment Pilot Pro gram (ASCA Pilot). These guidance documents outline the goals and implemen tation of the voluntary ASCA Pilot\, intended to increase confidence in te sting results from ASCA-accredited testing laboratories for certain FDA-re cognized standards and help the FDA ensure safe\, effective\, and high-qua lity medical devices are available to patients without unnecessary delay.\ nThe three guidances are:\n* Program Guidance: The Accreditation Scheme fo r Conformity Assessment (ASCA) Pilot Program\n \n* Basic Safety and Essent ial Performance Standard-specific Guidance: Basic Safety and Essential Per formance of Medical Electrical Equipment\, Medical Electrical Systems\, an d Laboratory Medical Equipment- Standards Specific Information for the Acc reditation Scheme for Conformity Assessment (ASCA) Pilot Program\n* Biocom patibility Standard-specific Guidance: Biocompatibility Testing of Medical Devices- Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program\n \nWebinar Details:\nRegistrat ion is not necessary.\nDate: October 22\, 2020\nTime: 1:00 PM-2:30 PM East ern Time\n\n\nTo ensure you are connected\, please dial-in 15 minutes befo re the start of the webinar\nNOTE: You must dial-in to hear the presentati on and ask questions:\nU.S. Callers Dial: 888-455-1392\nCONFERENCE NUMBER: PWXW1710003\nPASSCODE: 5276135\nInternational Callers Dial: 1-773-799-38 47 \nCONFERENCE NUMBER: PWXW1710003\nPASSCODE: 5276135\nTo view the slide presentation during the webinar:\nhttps://www.mymeetings.com/nc/ join.php?i=PWXW1710003&p=5276135&t=c \nFollowing the webinar\, a transcript\, audio recording and slides will be posted below. \nWe appreciate your fee dback on our webinar program. After the webinar\, we will provide a link t o a short survey about your experience\, which should take no more than 5- 10 minutes to complete. Your responses are confidential and will be used t o improve the quality of our webinar program.\nNOTE: The FDA does not prov ide Continuing Education Credits (CEU) or Certificates of Attendance.\n \n DTEND;TZID="Eastern Standard Time":20201022T143000 DTSTAMP:20200923T180511Z DTSTART;TZID="Eastern Standard Time":20201022T130000 LAST-MODIFIED:20200923T180511Z LOCATION:WebEx PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:FDA Webinar – Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program – Final Guidances TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E008000000009077C1CFB191D601000000000000000 01000000071F7ADF855CA7640874D89EAB7A07568 X-ALT-DESC;FMTTYPE=text/html:< body lang=EN-US link=blue vlink=purple style='tab-interval:.5in'>

Summary:

On October 22\, 2020\, the FDA will host a webinar for the medical devi ce industry and other stakeholders to discuss and answer questions about t hree final guidance documents related to the Accreditation Scheme for Conf ormity Assessment Pilot Program (ASCA Pilot): Program Guidance\, Basic Saf ety and Essential Performance Standard-specific Guidance\, and Biocompatib ility Standard-specific Guidance

&nb sp\;

Background:

The U.S. Food and Drug Administration (FDA) issued three final guidan ce documents related to the Accreditation Scheme for Conformity Assessment Pilot Program (ASCA Pilot). These guidance documents outline the goals an d implementation of the voluntary ASCA Pilot\, intended to increase confid ence in testing results from ASCA-accredited testing laboratories for cert ain FDA-recognized standards and help the FDA ensure safe\, effective\, an d high-quality medical devices are available to patients without unnecessa ry delay.

The three guidances are:< o:p>

  • Program Guidance: The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
  • Basic Safety and Essential Perfor mance Standard-specific Guidance: Basic Safety and Essential Performance of Medical Electrical Equipment\, Medical Electrical Systems\, and Labora tory Medical Equipment- Standards Specific Information for the Accreditati on Scheme for Conformity Assessment (ASCA) Pilot Program
  • Biocompatibility Standard-specific Guidance: Biocompatibility Testing of Medical Devices- Standards Specific Informat ion for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Pr ogram

 \;

Webinar D etails:

Regis tration is not necessary.

Date: October 22\, 2020
Time:
1:00 PM-2:30 PM Eastern Time

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

NOTE: You must dial-in to hear the presentation and ask quest ions:

U.S. Callers Dial: \;888-455-1392
CONFERENCE NUMBER: PWXW1710003
PASSCOD E: 5276135

International Callers Dial: \; 1-773-799-3847 \; \; \; \; \;  \; \; \; \; \;
CONFERENCE NUMBER: PW XW1710003
PASSCODE: 5276135

To view the slide presentation during the webinar:

h ttps://www.mymeetings.com/nc/join.php?i=PWXW1710003&\;p=5276135&\;t= c \;

Fol lowing the webinar\, a transcript\, audio recording and slides will be pos ted below.

We appreciate your feedback on our webinar p rogram. After the webinar\, we will provide a link to a short survey about your experience\, which should take no more than 5-10 minutes to complete . Your responses are confidential and will be used to improve the quality of our webinar program.

NOTE: The FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendance.< o:p>

 \;

X-MICROSOFT-CDO-BUSYSTATUS:BUSY X-MICROSOFT-CDO-IMPORTANCE:1 X-MICROSOFT-DISALLOW-COUNTER:FALSE X-MS-OLK-AUTOFILLLOCATION:FALSE X-MS-OLK-CONFTYPE:0 BEGIN:VALARM TRIGGER:-PT15M ACTION:DISPLAY DESCRIPTION:Reminder END:VALARM END:VEVENT END:VCALENDAR