Foley & Lardner LLP partner Kyle Faget discussed the U.S. Food and Drug Administration’s (FDA) classification of laboratory-developed tests (LDTs) as medical devices in the Medical Device Network article, “Explainer: Why paediatric healthcare is furious with the FDA’s LDT final ruling.”
“I think what the FDA was really trying to get at is because in the old days, LDTs were tests that were developed in a single hospital system and used in a single hospital system,” said Faget, who is co-chair of Foley’s Health Care Practice and of the Medical Device and Equipment Area of Focus within the firm’s Health Care & Life Sciences Sector. “That’s just not how LDTs in the modern day are functioning. They are being developed by highly sophisticated laboratories and being sold across the US and across the world in many cases for diagnostic purposes.”
“So, from the FDA’s perspective, that’s a whole different commercial activity than what it was when the FDA was choosing to exercise its enforcement discretion,” Faget continued. “In other words, the FDA’s position is that they always could have regulated LDTs but have chosen not to because they were low risk.”
“The last thing the FDA wants is for there to be a test out on the market for something like Down’s syndrome that is not actually effective and is out in the marketplace,” Faget added. “That is exactly the FDA’s concern – that there are diagnostic tests that don’t work correctly or are giving erroneous results.”
