Module 14 2022

21/03/2022

Identify leachable substance

Evaluate exposure, duration and route

Collect and evaluate toxicity data

Do adequate data exist?

NO

YES

Obtain data, conduct evaluation

Determine acceptable levels

The Organisation for Professionals in Regulatory Affairs

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Biological Evaluation Report - 1

 No specific guidance

Introduction

• Categorisation of Medical Device

ABC Cream is categorized as a surface-contacting device to be used exclusively on the skin. The duration of contact is most likely to be that defined by limited exposure (total not exceeding 24 hours).

The Organisation for Professionals in Regulatory Affairs

20

10

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