Stacy Cline Amin spoke to Bloomberg Law about a diagnostics reform bill known as the VALID Act, which the Food and Drug Administration (FDA) has long supported and for which it provided technical assistance. The VALID Act moves away from device standards that focus on whether a test is equivalent to an existing diagnostic, instead shifting the mindset to whether the test works.
Stacy cautioned that the industry should be ready for FDA to move ahead, and pushed back on arguments that rulemaking will take years at FDA and that the agency is afraid of litigation.
"FDA is ready for litigation," Stacy said. "Yes, there are legal challenges, but I think the industry should be paying attention."
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