Module 16 2024

23/10/2024

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

Guidance

Directive

When?

When?

● Serious public health threat:

● Immediately

2 days

● Death or unanticipated serious deterioration in state of health: 10 days

● Other:

30 days

Causality?

Causality? ● Implied

● Explicit

Worldwide Incidents? ● Yes

Worldwide Incidents

● No – only if FSCA

No trends/signals?

Trends/signals

Recalls

FSCAs

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