What Are The Key Focus Areas In The Evaluation Of Acute, Subacute, Subchronic, And Chronic Toxicity, And Can These Tests Replace One Another? If A Product Has Undergone Acute Systemic And Subchronic Systemic Toxicity Tests, Can Subacute Systemic Toxicity Tests Be Waived? Under What Circumstances Is It Not Possible To Waive Subacute Systemic Toxicity Testing?

1. The evaluation focus for acute, subacute, subchronic, and chronic toxicity is distinguished based on the definitions of each test. Consider factors such as the product’s contact duration (within 24 hours vs. more than 14 days to 12 months of repeated or prolonged contact), toxicity observation periods (within 72 hours vs. after 14 days to 12 months of repeated or prolonged contact), and observation technical indicators.
2. Select subacute, subchronic, and chronic toxicity tests reasonably based on the clinical use duration of the device.
3. Subchronic toxicity can generally replace subacute toxicity to obtain long-term toxicity data, but actual product usage conditions should be considered to avoid over-testing.