5/21/2024 3:30:26 PM FDA LDT Rule Begins Enforcement Discretion Phaseout, But Some Discretion Remains By Rebecca Jones McKnight Kevin Madagan Sarah Thompson Schick Akosua Tuffuor +1 more... Show less On May 14, 2024, FDA hosted a webinar to provide an overview of its final rule “Medical Devices; Laboratory Developed Tests” as well as...
1/26/2023 8:51:12 PM Health Provisions of the Consolidated Appropriations Act, 2023: Part 2 The PIE Act By Rebecca Jones McKnight Nancy Halstead Sarah Thompson Schick Tamra Harris Matthew Loughran +2 more... Show less [Note, this is Part 2 in an ongoing series of posts exploring substantive aspects of the Consolidated Appropriations Act, 2023 (P.L....
10/14/2021 1:24:04 PM FDA codifies requirements for the medical device De Novo classification process By Andrew Lu On October 5, 2021, the U.S. Food and Drug Administration (“FDA”) published a final rule to establish requirements for the medical device...