Do All Medical Devices Require Chemical Characterization?

The role of chemical characterization in biological evaluation:
1. Provide chemical information for comparing the device under application with marketed devices (determine equivalence).
2. Provide a chemical basis for comparing the device under application with relevant material standards (confirm compliance).
3. Serve as the chemical information basis for toxicological risk assessment (ensure feasibility of the assessment).
More in-depth and complex chemical characterization and data evaluation may be needed in the following situations:
1. The materials used lack a long history of clinical use.
2. Unexpected results occur in biological tests.
3. The device’s materials change upon application to the human body (e.g., in situ polymerization or resorbable materials).
4. The medical device contains known toxic materials.
5. New chemical substances are used in the material components or production process.
6. The medical device is made of new materials.