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:20190711T152027Z DESCRIPTION:On Tuesday\, August 13\, 2019\, the U.S. Food and Drug Administ ration (FDA) will host a webinar on two FDA Innovation Challenges to spur the development of new approaches to device sterilization.\nIn response to the March 2019 closure of a large device sterilization facility\, the FDA is taking steps to ensure that hospitals\, health care providers\, and patients have access to medical devices that are safely and effectively s terilized.\nOn July 15\, 2019\, the FDA announced the launch of two public innovations challenges to encourage innovation in medical device steriliz ation.\n· Challenge 1 is focused on identifying alternatives to ethylene oxide (EtO) sterilization methods.\n\n * Challenge 2 is focused on devel oping strategies to reduce ethylene oxide (EtO) emissions.\nThe FDA’s Ce nter for Devices and Radiological Health will accept applications for this challenge from July 15\, 2019 through October 15\, 2019.\nThe FDA encoura ges participation in this challenge from organizations such as:\n• Medical device companies or distributors\n• Technology manufact urers (including start-up companies or labs)\n• Academic and rese arch institutions\n• Healthcare facilities\n• Profession al societies\n• Foundations and other non-profits\n\nWebinar Deta ils:\nRegistration is not necessary.\n\nDate: August 13\, 2019\nTime: 03: 00 PM – 04:30 PM\, EDT\nTo ensure you are connected\, please dial-in 15 minutes prior to the start of the webinar.\n\nU.S. Callers Dial:\n\n * 800-857-5152\n * Conference Number: PWXW9315475\n * Passcode: 12736 30\n\nInternational Callers Dial:\n\n * 1-212-547-0162\n * Conferenc e Number: PWXW9315475\n * Passcode: 1273630\n\nTo view the slide prese ntation during the webinar:\nhttps://www.mymeetings.com/nc/join.php?i=PWXW 9315475&p=1273630&t=c\n\nFollowing the webinar a transcript\, recording an d slides will be available at:\n\nhttp://www.fda.gov/CDRHWebinar\n\nWe app reciate your feedback on our webinar program. Following the webinar\, we w ill provide a link to a short survey about your FDA CDRH webinar experienc e\, which should take no more than 5-10 minutes to complete. Your response s are confidential and will be used to help ensure the quality of our webi nar program.\n\nNote: The FDA does not provide Continuing Education Credit s (CEU) or Certificates of Attendance for webinar attendance.\n\nTarget Au diences: Industry (medical device companies or distributors\, technology m anufacturers (including start-up companies or labs)\, academic and researc h institutions\, healthcare facilities\, professional societies\, foundati ons and other non-profits\n\nIf you have any questions regarding this guid ance 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.\n\nFood and Drug Administration\nCenter for Device s and Radiological Health\n DTEND;TZID="Eastern Standard Time":20190813T163000 DTSTAMP:20190711T152028Z DTSTART;TZID="Eastern Standard Time":20190813T150000 LAST-MODIFIED:20190711T152027Z LOCATION:FDA PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:FDA Webinar-FDA Innovation Challenges: Identifying S terilization Alternatives and Reducing Ethylene Oxide Emissions TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E00800000000E0AB1E491737D501000000000000000 010000000F22E0BBE2A2FFB408DA0B36243C013E5 X-ALT-DESC;FMTTYPE=text/html:\n\n110\nClean\nDocumentEmail\n\n\n\n\n\nfalse\nfalse\nfalse\n\nEN-US\nX-NONE\nX-NONE\n\n\n \n\n\n\n \n\n\n\n\n\nMicrosoftInternetExplorer4\n\n\n\n\n\n\n\n\n\n\n\n\n\n

On Tues day\, August 13\, 2019\, the U.S. Food and Drug Administration (FDA) will host a webinar on two FDA Innovation Challenges to spur the development of new approaches to device sterilization.

In response to the March 2019 closure of a large device sterilization fac ility\, the FDA is taking steps to ensure that hospitals\, heal th care providers\, and patients have access to medical devices that are s afely and effectively sterilized. \;

On July 15\, 2019\, the FDA announced the launch of two pub lic innovations challenges to encourage innovation in medical device steri lization.

·\; \; \; \; \; \; \; \; Challenge 1 is focused on identifying alternatives to et hylene oxide (EtO) sterilization methods. \;

  • Challenge 2 is focused on developing strategies to reduce ethyl ene oxide (EtO) emissions.

The FDA’\;s Center for Devices and Radiological Hea lth will accept applications for this challenge from July 15\, 2019 throug h October 15\, 2019.

The FDA encourages participation in this chall enge from organizations such as:

•\;&nb sp\; \; \; \; \; \; \; Medical device companies or distributors

•\; \; \; \; \; \; \; \; Technology manufacturers (including start-up companies or labs)< /o:p>

•\; \; \;  \; \; \; \; \; Academic and research i nstitutions

•\; \; \; \; \; \; \; \; Healt hcare facilities

•\; \; \; \; \; \; \; \; < /span> Professional societies

•\; \; \; \; \; \; \; \; Foundations and other non-profits

 \;< /p>

Webinar Details:

Regis tration is not necessary.

Date: \; August 13\, 2019
Tim e: \;03:00 PM –\; 04:30 PM\, EDT
To ensure you are connected\, please dial-in 15 minutes prior to the start of the webinar.

U.S. Callers Dial: \;

  • 800-857-5152
  • Conference Number: \; PWXW9315475
  • Passcode: 1273630

International Callers Dial:

  • 1-212-547-0162
  • C onference Number: \; PWXW9315475 < /o:p>
  • Passcode: 1273630

To view the slide presentation during the webinar:
https://www.mymeetings.com/nc/join.php?i=P WXW9315475&\;p=1273630&\;t=c

Following the webi nar a transcript\, recording and slides will be available at:

http:/ /www.fda.gov/CDRHWebinar

We appreciate your feedback on our webinar program. Following the web inar\, we will provide a link to a short survey about your FDA CDRH webina r experience\, which should take no more than 5-10 minutes to complete. Yo ur responses are confidential and will be used to help ensure the quality of our webinar program.

Note: The FDA does not provide Continuing Education Credits (CEU) or Cer tificates of Attendance for webinar attendance.

Target Audiences: Industry (med ical device companies or distributors\, technology manufacturers (includin g start-up companies or labs)\, academic and research institutions\, healt hcare facilities\, professional societies\, foundations and other non-prof its

I f 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 Health

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