Designing for Medical or Food Applications? Here's What You Need to Know:
When creating products for medical devices, packaging systems, or any application that involves human or veterinary use, it's crucial to understand FDA regulations. These regulations govern the materials used in your design, ensuring they are safe and suitable for their intended use.
At MPC, we specialize in helping product designers select and manufacture with FDA complaint thermoset polyurethanes, which are versatile and customizable materials for a wide range of applications. Below, we break down the essentials for identifying FDA compliant plastics and getting your design off to the right start.
Key Points:
The Food and Drug Administration (FDA) is a U.S. government agency that is responsible for protecting the public’s health and safety. Because of this, the FDA regulates a variety of products, including but not limited to, medical devices, electronics that emit radiation, along with food & drugs. For a complete list of FDA regulations, click here.
Whether or not your product needs to comply with FDA regulations depends on its function and intended use. Often, FDA compliance is required for a full system or assembly, not just individual components. For instance, a mobile medical device, similar to the item described in our latest case study, may not require FDA-approved materials unless it interacts with users or the environment in a critical way. Products that contact the human body or food, however, typically do require FDA compliant materials.
The best way to determine compliance is to consult the FDA or your manufacturing partner early in the design process.
Once you know the FDA compliance requirements for your product, you can begin exploring manufacturing processes and materials. Thermoset polyurethanes, for example, offer flexible formulation options that can be customized to meet FDA standards. Unlike metals, rubber, and many plastics, polyurethanes allow for the adjustment of properties like hardness and surface finish, making them an excellent choice for compliant designs
Work closely with your manufacturing partner to ensure the materials selected meet all necessary FDA documentation and certifications. Early communication is key to ensuring compliant formulation for your product or component.
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