Final Rule Clarifies Liability for Off-Label Uses and Lab’s Right to Create LDTs
On Aug. 2, 2021, the FDA published the long-awaited final rule updating its “intended use” regulations for medical devices and drugs. Here’s a quick briefing of the new rules, which took effect on Sept. 1. The “Intended Use” Regulations In 2015, FDA proposed to eliminate a regulatory requirement that a manufacturer “provide adequate labeling” to […]
On Aug. 2, 2021, the FDA published the long-awaited final rule updating its “intended use” regulations for medical devices and drugs. Here’s a quick briefing of the new rules, which took effect on Sept. 1. The “Intended Use” Regulations In 2015, FDA proposed to eliminate a regulatory requirement that a manufacturer “provide adequate labeling” to […]
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