Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight
FDA Law Blog
JULY 7, 2024
The guidance restates the central premise of the final rule, i.e., that LDTs are medical devices and the clinical laboratories that design, manufacture and use them to test patient specimens are manufacturers. MDRs must be reported to FDA in electronic format. 803), Reporting of Corrections and Removals (21 C.F.R. § 820.198). .
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