In a Bloomberg Law article, life sciences regulatory & compliance partner Joshua Oyster discussed the Food and Drug Administration final rule to regulate lab-developed tests.
A key question is whether the FDA possesses the legal authority to regulate LDTs. Expected lawsuits will challenge how the FDA will enforce the regulation as labs determine whether they are subject to a phaseout policy or face full or partial enforcement discretion.
“The enforcement discretion policies adopted in the final rule can help, but they don’t necessarily change the core legal issues. At some point, one or more entities are going to challenge the legality of the rule,” said Joshua.
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