Module 16 2022

02/09/2022

Field Safety Corrective Action (“FSCA”)

FSCA may include the following actions ● return of a medical device to supplier ● device modification

● device exchange ● device destruction ● retrofit by purchaser of manufacturer's modification or design change ● advice given by manufacturer regarding use of device

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Directives vs Guidance Directive When? ● Immediately

Guidance When? ● Serious public health threat: 2 days ● Death or unanticipated serious deterioration in state of health: 10 days ● Other: 30 days

Causality? ● Explicit

Causality? ● Implied

Worldwide Incidents? ● Yes

Worldwide Incidents ● No – only if FSCA

No trends/signals?

Trends/signals

Recalls

FSCAs

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