BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//Ignite II - ECPv6.15.20//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:Ignite II
X-ORIGINAL-URL:https://gmkb.org
X-WR-CALDESC:Events for Ignite II
REFRESH-INTERVAL;VALUE=DURATION:PT1H
X-Robots-Tag:noindex
X-PUBLISHED-TTL:PT1H
BEGIN:VTIMEZONE
TZID:America/New_York
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:20220313T070000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:20221106T060000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:20230312T070000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:20231105T060000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:20240310T070000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:20241103T060000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20231031T130000
DTEND;TZID=America/New_York:20231031T140000
DTSTAMP:20260426T032835
CREATED:20231029T203025Z
LAST-MODIFIED:20231029T205222Z
UID:3580-1698757200-1698760800@gmkb.org
SUMMARY:FDA Webinar | Proposed Rule: Medical Devices; Laboratory Developed Tests
DESCRIPTION:Proposed Rule: Medical Devices; Laboratory Developed Tests \nTuesday\, October 31 | 1 p.m. ET | Online \nThe U.S. Food and Drug Administration (FDA) will host a public webinar to provide information on the proposed rule regarding Laboratory Developed Tests (LDTs). During the webinar\, the FDA will: \n\nProvide an overview of the rulemaking proposal to amend the FDA’s regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food\, Drug\, and Cosmetic Act including when the manufacturer of the IVD is a laboratory.\nDescribe the proposed phaseout of FDA’s general enforcement discretion approach to LDTs.\nHost a Q&A session based on questions that have been submitted prior to the webinar at CDRHWebinars@fda.hhs.gov. Questions will not be taken during the live webinar. All questions are due by October 23\, 2023\, to be considered for the discussion.\n\nRegistration is not required. To learn more and access the Zoom webinar details\, visit the event page.
URL:https://gmkb.org/event/fda-webinar-proposed-rule-medical-devices-laboratory-developed-tests/
LOCATION:Virtual
END:VEVENT
END:VCALENDAR