In a MedTech Dive article, life sciences regulatory & compliance partner Greg Levine discussed how the recent U.S. Supreme Court decision to overturn the Chevron doctrine could impact the medical device industry and lead to more challenges of Food and Drug Administration regulations, including the agency’s rule on laboratory developed tests.
The Supreme Court ruling made clear that on questions of ambiguous statutory interpretation, there is no deference due to federal agencies.
“Industry players, manufacturers and other stakeholders will be less reticent to challenge FDA. That inevitably will slow down some FDA policymaking or publication of rules,” said Greg.
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