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

FDA Law Blog

Section IV, Additional Resources, provides links to previously-issued guidance documents and other educational materials geared to traditional device manufacturers, with no additional commentary on how to apply these requirements to the very different clinical laboratory environment. 803), Reporting of Corrections and Removals (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. educational records (diplomas, degrees, transcripts, etc.), notarial attestations, and more. Contact us today to get your project started.