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The FDA has issued a final rule to regulate laboratory-developed tests as medical devices, creating exceptions that are causing compliance concerns among industry members. Several law firms and publications have covered the details and implications of the new rule.
What’s in the FDA Final Rule Regulating Laboratory-Developed Tests as Medical Devices? https://t.co/kFhzMCz0mD
[VIDEO] FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law https://t.co/cVIz5yJoe8 | by @ebglaw
Discretion No More: FDA’s New Final Rule Regulating Laboratory Developed Tests https://t.co/5MyCOoqts5 | by @HuschBlackwell






