Module 16 2024

22/10/2024

Practical Effects of Failures to Act

Withdraw/recall product or warn

Adequate warnings render unsafe devices safe

Most product liability actions are based on failures to warn

What constitutes an adequate warning? ● Question of fact in each case ● An ethical, regulatory and business decision ● There is no easy answer

Differences is professional or patient use

The Organisation for Professionals in Regulatory Affairs

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Reducing Liability

Best practices in design, production and QA

Define and update risk management procedures

Contractual steps ● Standard terms and conditions ● Exclusion clauses and indemnities FSCA, crisis management and recall plans

Insurance

Timely regulatory interactions

Write defensive documents

International harmonization of labelling

Device vigilance and corrective actions

The Organisation for Professionals in Regulatory Affairs

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