FDA Law Blog

SEPTEMBER 22, 2024

MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCF : LDT, unmet need within an integrated healthcare system. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule.

Manufacturing 64

Manufacturing Electronics Provider Management 64

FDA Law Blog

JULY 7, 2024

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.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

FDA Law Blog

MAY 21, 2024

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 61; NPRM at 44,615. at 44,617, 44,619. Basis at 64-65.

Physicals 69

Physicals Medical Clinic Emergency Room 69