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
19
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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