Regulatory Expert Weighs in on Impact of the LDT Final Rule
Manufacturers of laboratory-developed tests (LDT) are concerned that the FDA will lack the resources to deal with a flood of premarket approval applications as the agency implements its recent final rule asserting oversight of LDTs as medical devices.
The FDA has historically considered LDTs to be a subset of in vitro diagnostics that are designed, manufactured and used within a single laboratory and the agency has generally exercised “enforcement discretion” for such tests. But the FDA now believes increased oversight is needed because large, nationwide clinical laboratories are using LDTs in high volumes.
“One of the biggest concerns from labs and other stakeholders is the burden of complying with premarket review requirements,” said Joshua Oyster, a partner at the law firm Ropes & Gray.
“That’s really where the rubber meets the road in terms of the burden on labs, [including] the resources that FDA has or doesn’t have to review all the submissions that are going to be coming,” he said, in a recent webinar hosted by FDAnews, a WCG company.
Access the full webinar, “FDA Oversight of Laboratory Developed Tests — The Impact of the Final Rule,” here.
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