To Be (a Device) or Not To Be. That’s The Legal Question

Healthcare policy attorney Sarah Klock was quoted in a recent Medtech Insight article about the U.S. Food and Drug Administration's (FDA) final regulations regarding laboratory developed tests (LDTs). The FDA's rule treats LDTs as medical devices, which gives the agency regulatory authority, but opponents argue the regulations are an example of government overreach. The article cited the Federal Food, Drug and Cosmetic (FD&C) Act, which defined medical devices in Section 201(h). Ms. Klock said the legislation is open to interpretation as to whether LDTs should be considered medical devices.

"There are strong regulatory arguments from the FDA's perspective that they have the authority. I think they've always thought that an LDT was a medical device and now they're just acting on that authority, but I can also see that there may be other arguments that it is not a medical device,” Ms. Klock said. "Before all of this, an LDT was defined as an in vitro diagnostic that was performed at a single lab. So, in theory, an in vitro diagnostic test that was performed in multiple labs didn’t meet the definition of an LDT. It was a narrowly crafted exclusion.”

READ: To Be (a Device) or Not To Be. That’s The Legal Question