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Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

FDA Law Blog

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

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Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law Blog

and its abuse may lead to only moderate or low physical dependence or high psychological dependence. Public comments must be submitted electronically or postmarked on or before July 22, 2024, 60 days after publication in the Federal Register. 21 U.S.C. § 21 U.S.C. § Basis at 24. NPRM at 44,607. Basis at 61; NPRM at 44,615.