Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight
FDA Law Blog
JULY 7, 2024
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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