Date(s) - 23 Aug 2022
8:00 AM - 9:00 AM
The VALID Act: What is it? How might it impact the diagnostics industry?
How would the pending VALID Act impact your institution and the diagnostics and healthcare industries?
Please join us on Tuesday, August 23 at 8:00 am Pacific (11:00 am Eastern) for a webinar 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 health care policy and legislation.
Please register using the button below. You will receive a calendar invite and Zoom link ahead of the event. We are excited for what is sure to be a robust discussion and look forward to your questions and insights as engaged members of the diagnostics community.
What Is the VALID Act?
The Verifying Accurate Leading-edge IVCT Development (VALID Act) is a complex bill that has been under discussion for many years in Congress. Recently it was included in a larger legislative package focused on Food and Drug Administration (FDA) user fees. User fees are akin to application fees levied on for-profit commercial entities 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.”
The VALID Act would establish a new category to include in vitro clinical tests (IVCTs) comprised of both commercial test kits and laboratory developed tests (LDTs). Using a risk-based framework, tests would also require pre-market review. If enacted, this legislation could have a significant impact on clinical microbiology laboratories that use LDTs routinely for infectious disease diagnostic testing and surveillance.