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:20190918T160330Z DESCRIPTION:On Thursday\, November 7\, 2019\, the U.S. Food and Drug Admini stration (FDA) will host a webinar on the Safety and Performance Based Pat hway guidances.\nBackground: On September 19\, 2019\, the FDA issued four draft guidances and updated a final guidance related to the Safety and Per formance Based Pathway as part of our commitment to strengthening and mode rnizing the 510(k) program\, as described in the FDA’s Medical Device Sa fety Action Plan. \nAs a first step towards implementation of the Safety a nd Performance Based Pathway\, the FDA issued four draft guidances that id entify performance criteria and testing methodologies for certain devices within four class II device types:\n* Conventional Foley Catheters \n* Cutaneous Electrodes for Recording Purposes \n* Orthopedic Non-Spinal Metallic Bone Screws and Washers \n* Spinal Plating Systems \n\nThe FDA also up dated the Safety and Performance Based Pathway final guidance.\n\nWebinar Details:\n\nRegistration is not nec essary.\nDate: November 7\, 2019\nTime: 1:00 PM – 2:30 PM\, EDT\nTo ens ure you are connected\, please dial-in 15 minutes prior to the start of th e webinar.\nU.S. Callers Dial: \n* 888-945-5893\n* Conference Number: PWX W9528798\n* Passcode: 5705130\nInternational Callers Dial:\n* 1-212-547-01 52\n* Conference Number: PWXW9528798\n* Passcode: 5705130\nTo view the sl ide presentation during the webinar:\nhttps://www.mymeetings.com/nc/join.p hp?i=PWXW9528798&p=5705130&t=c\nFollowing the webinar a transcript\, recor ding and slides will be available at: http://www.fda.gov/CDRHWebinar \nWe appreciate your feedback on our webinar program. Following the webinar\, w e will provide a link to a short survey about your FDA CDRH webinar experi ence\, which should take no more than 5-10 minutes to complete. Your respo nses are confidential and will be used to help ensure the quality of our w ebinar program.\nNote: The FDA does not provide Continuing Education Credi ts (CEU) or Certificates of Attendance for webinar attendance.\nTarget Aud iences: Industry (medical device companies or distributors\, technology ma nufacturers (including start-up companies or labs)\, academic and research institutions\, healthcare facilities\, professional societies\, foundatio ns and other non-profits\nIf you have any questions regarding this guidanc e document\, please contact CDRH’s Division of Industry and Consumer Edu cation (DICE) at dice@fda.hhs.gov \, 1-800-638-2 041\, or 301-796-7100.\nFood and Drug Administration\nCenter for Devices a nd Radiological Health\n \n DTEND;TZID="Eastern Standard Time":20191107T143000 DTSTAMP:20190918T160330Z DTSTART;TZID="Eastern Standard Time":20191107T130000 LAST-MODIFIED:20190918T160330Z LOCATION:FDA PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:FDA Webinar- Safety and Performance Based Pathway Pe rformance Criteria TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E00800000000E0AC2752186ED501000000000000000 010000000460ACDD03966EB4983652122DCA8AE56 X-ALT-DESC;FMTTYPE=text/html:

On Thursday\, November 7\, 2019\, the U.S. Food and Drug Administration (FDA) will host a webinar on the Safety and Performance Based Pathway guidances.< /p>

Background: On September 19\ , 2019\, the FDA issued four draft guidances and updated a final guidance related to the Safety and Performance Based Pathway as part of our commitm ent to strengthening and modernizing the 510(k) program\, as described in the FDA’\;s Medical Device Safety Action Plan.

As a first step towards implementation of the Safety and Performance Based Pathway\, the FDA issued four draft guid ances that identify performance criteria and testing methodologies for&nbs p\; certain devices within four class II device types:


Th e FDA also updated the Safety and Performance Based Pathway final guidance.

Webinar Details:

Registration is n ot necessary.

Date: \; Novemb er 7\, 2019
Time: \;1:00 PM –\; 2:30 PM\, EDT
To ensure you are connected\, please dial-in 15 minutes prior to the start of the webin ar.

U.S. Callers Dial: \;

  • 888-945-5893
  • Conference Number: \; PWXW9528798< /span>
  • Passcode: 5705130

International Callers Dial:

  • 1-212-547-0152
  • Conference Number: \; PWXW9528798
  • Passcode: 5705130

To view the slide presentation during the webinar:
https://www.mymeetings.com/nc/join.php?i=PWXW95 28798&\;p=5705130&\;t=c

Following the webinar a transcr ipt\, recording and slides will be available at: http://www.fda.gov/CDRHWebinar

We appreci ate your feedback on our webinar program. Following the webinar\, we will provide a link to a short survey about your FDA CDRH webinar experience\, which should take no more than 5-10 minutes to complete. Your responses ar e confidential and will be used to help ensure the quality of our webinar program.

Note: The FDA does not provide Continui ng Education Credits (CEU) or Certificates of Attendance for webinar atten dance.

Target Audiences: Industry (medical device companies or dis tributors\, technology manufacturers (including start-up companies or labs )\, academic and research institutions\, healthcare facilities\, professio nal societies\, foundations and other non-profits

If you have any questions regarding this guidance document\, please contact CDRH’\;s Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov\, 1-800-638-2041\, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological He alth

 \;

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