Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight
FDA Law Blog
JULY 7, 2024
2] The regulations require manufacturers to establish a “formally designated [complaint handling] unit,” [3] which can be accomplished by describing the unit in a procedure and/or including a diagram that identifies individuals, activities, and departments that are charged with “…receiving, reviewing, and evaluating” complaints. [4]
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