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Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight
FDA Law Blog
JULY 7, 2024
12] Reporting under the MDR regulation is required within 30 calendar days of “becoming aware” of such an event, unless remedial action is necessary to prevent unreasonable risk of substantial harm to the public health, in which case reporting must occur within 5 work days. [13]
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