In the USA, the FDA has specific requirements for medical device labels, instructions for use (IFU), and packaging. Here’s a detailed overview:
General Requirements: Labels must be legible, in English, and prominently placed. They must include the following elements:
Special Requirements:
Content Requirements: The IFU must provide comprehensive instructions on how to use the device safely and effectively:
Format and Accessibility:
General Requirements: Packaging must ensure that the device remains sterile and undamaged until use. Requirements include:
Special Considerations:
Ensure to review the FDA’s specific guidelines and regulations for your device type, as additional requirements may apply based on the device's classification and intended use.
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