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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
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.