Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight
FDA Law
JULY 7, 2024
Labeling We note that while labeling requirements are not being phased in until stage 2 (May 6, 2026), the regulatory requirements in stage 1 appear to assume that at least some labeling requirements – such as UDI, which must be included in complaint files – will already be implemented).
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