BEGIN:VCALENDAR VERSION:2.0 PRODID:-//wp-events-plugin.com//7.2.3.1//EN TZID:America/Phoenix X-WR-TIMEZONE:America/Phoenix BEGIN:VEVENT UID:1737@azbio.org DTSTART;TZID=America/Phoenix:20220823T080000 DTEND;TZID=America/Phoenix:20220823T090000 DTSTAMP:20220817T034829Z URL:https://www.azbio.org/events/the-valid-act-what-is-it-how-might-it-imp act-the-diagnostics-industry SUMMARY:The VALID Act: What is it? How might it impact the diagnostics in dustry?  - - 23 Aug 22 08:00 DESCRIPTION:The VALID Act: What is it? How might it impact the \;diagno stics \;industry? \;\nHow would the pending VALID Act impact your institution and the diagnostics and healthcare industries?\n\nPlease join us on Tuesday\, August 23 at 8:00 am Pacific (11:00 am Eastern) for a webi nar on the VALID Act – the first major change to diagnostics regulation in the last 20 years. You will hear from Ralph Hall\, principal at Leavitt Partners and expert in FDA regulations\, regulatory compliance\, and heal th care policy and legislation. \;\n\nPlease register using the button below. You will receive a calendar invite and Zoom link ahead of the even t. We are excited for what is sure to be a robust discussion and look forw ard to your questions and insights as engaged members of the diagnostics c ommunity.\n\n\nWhat Is the VALID Act?\nThe Verifying Accurate Leading-edge IVCT Development (VALID Act) is a complex bill that has been under discus sion for many years in Congress. Recently it was included in a larger legi slative package focused on Food and Drug Administration (FDA) user fees. U ser fees are akin to application fees levied on for-profit commercial enti ties for medical devices and drugs that are reviewed by the FDA. User fee agreements help to fund FDA operations and are reauthorized every 5 years\ , making it “must pass legislation.”  \;\n\nThe VALID Act would es tablish a new category to include in vitro clinical tests (IVCTs) comprise d of both commercial test kits and laboratory developed tests (LDTs). Usin g a risk-based framework\, tests would also require pre-market review. If enacted\, this legislation could have a significant impact on clinical mic robiology laboratories that use LDTs routinely for infectious disease diag nostic testing and surveillance.\n\nLearn more at https://asm.org/Articles /Policy/2022/May-2022/Explaining-the-VALID-Act END:VEVENT BEGIN:VTIMEZONE TZID:America/Phoenix X-LIC-LOCATION:America/Phoenix BEGIN:STANDARD DTSTART:20210823T080000 TZOFFSETFROM:-0700 TZOFFSETTO:-0700 TZNAME:MST END:STANDARD END:VTIMEZONE END:VCALENDAR