The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to soft (hydrophilic) daily wear contact lenses.
The document further outlines specific criteria related to the safety and performance medical device manufacturers should take into consideration when placing their products on the market. The guidance also describes specific tests to be completed in order to assess compliance with the respective regulatory requirements. In particular, the document describes the tests addressing such aspects as:
- Physicochemical and optical properties
- Mechanical properties
- Packaging solution
- Sterilization
- Biocompatibility
Due to contact lenses being medical devices intended to be in contact with a patient’s tissue, and also due to the extent and duration of such contact, the authority pays special attention to the aspects related to biocompatibility.
According to the guidance, medical devices described therein are considered “surface devices with a limited mucosal membrane contact duration of up to 24 hours”.
For more information, please refer to the link below.
If you have any questions about medical device certification,
Please contact us with the below.
info@jnmglobal.net
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