Work with our team of color experts today to achieve the desired color for your device!
Our team has a lengthy reputation for providing accurate colormatches for a wide range of medical device applications. From existing parts to the Pantone Matching System, color concentrates to
pre-colored compounds, our team of experts develops custom formulations that provide consistency and compliance.
Color selection in the product design process is often decided by the marketing team but it is a key part for the design, especially within the medical device industry. In recent years, the FDA has imposed more strict standards and approvals on colorants used in medical devices, which can also limit the final color options available for medical devices depending on final end use.
In the medical device industry, colorants fall into two main areas of FDA approvals. Colorants approved under FDA 21 CFR 173-178 are considered to be “Food Grade”. The FDA has moved, in recent years, to expand the 21 CFR 73 Subpart D listings to include any device that has blood or body fluid contact. This list of colorants for use in medical devices are exempt from batch certification. The selection of initial pigments can greatly impact the FDA approval process for medical devices. Without proper selection rejection of the device is possible
Contact us today to discuss your desired color and help ensure a smooth FDA approval process.
For a list of colors that can be achieved utilizing FDA 21 CFR 73 Subpart D approved colorants, visit our EZ Med Color Selector!