Critics argue that the FDA’s plan to increase oversight of LDTs would slow development of cutting-edge diagnostics. Under the new rule, most LDTs would be regulated as medical devices, subject to pre-market review as other in vitro diagnostics are now, which can be a more expensive and longer process.
The FDA asserts the risks associated with LDTs have increased as the tests have become more complex and widely used, necessitating greater scrutiny to ensure their accuracy and safeguard patients.
