Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight
FDA Law Blog
JULY 7, 2024
A “correction” means “the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other location.” [15] Records of corrections and removals must be retained for a “period of 2 years beyond the expected life of the device.” [19]
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