If you are designing products for medical devices, packaging systems, or anything else that may encounter human or veterinary use, you should be informed of the regulations set forth by the FDA. While the realm of regulations is exceptionally vast, this post is solely intended to focus on a general overview and ways to identify FDA-compliant plastics for your next product design.

But first, what does the FDA do?

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.

Does your product need to meet FDA regulations?

Compliance with FDA regulations will depend on the type of product being developed and it's function. As a result, FDA compliance is most often required of a full system or assembly, rather than individual subcomponents or raw materials. For example, if you were designing an enclosure for a mobile medical device, similar to the item described in our latest case study, you may not require FDA-approved materials as the enclosures may not play a key role in the product's function or interact with users. On the other hand, products that are introduced into the human body or come in contact with food may require varying levels of compliance, including of subcomponents. The best way to identify FDA compliance requirements for your products is to check with the FDAs. 

How to identify FDA-Compliant plastics

Once you understand the regulatory environment your product must comply with, you can begin to explore manufacturing processes and materials to bring your product to life. The world of plastics includes a wide range of materials and chemistries that may be FDA-compliant for your application. The best way to identify if a plastic or material is FDA-compliant is by discussing with your manufacturing partner or material vendor. Your manufacturing partner should be able to discuss any documentation or certification you may require for your products. 

In the case of thermoset polyurethanes, there are a wide range of chemical formulations that may be FDA-compliant. Unlike metals, rubber, and plastics - polyurethane's chemistry allows for the customization of the materials chemistry and physical properties, such as hardnesses, and surface finishes. This allows product engineers to design what they envision without compromise. Communicating your FDA-compliance needs in the early stages of product development is key to assure that your manufacturing partner provides a compliant formulation.

If you are seeking material assistance for your next product design, complete our design tool, here, or click the banner below to complete 5 key design questions to start your custom polyurethane product today!