In today’s episode, we’re diving into a pretty big shift in how lab-developed tests are regulated in the United States. If you’re up on FDA developments, you may have heard that there’s an effort to regulate these tests as medical devices. But a recent federal court ruling in Texas just flipped the script.
Instead of agreeing with the FDA, the court basically said, “Nope, lab-developed tests aren’t devices—they’re services.” And services aren’t under the FDA’s jurisdiction.
Read the full article:
About the authors:
