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

FDA Law Blog

The first phaseout milestone is less than a year away; by May 6, 2025 most laboratories will need to demonstrate compliance with Medical Device Reporting (21 C.F.R. § 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

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The Alert: October – December 2023

Parasec

One such publication is the Small Entity Compliance Guide , which aims to help small businesses comply with the beneficial ownership information (BOI) reporting rule. The Financial Crimes Enforcement Network (FinCEN) recently published several documents to assist with understanding the new requirements.