Foster introduces FDA approved colour concentrates for medical devices

Foster Corporation, a provider of custom polymers for medical devices, has introduced a new line of colour concentrates using FDA 21CFR 73 subpart D pigments for medical device applications

In support of medical customers in early stages of product development, Foster said its MediBatch colour concentrates will be available in quantities as low as a single pound.

Colour concentrates, blended with unpigmented polymers are widely used as an economical alternative to pre-coloured formulations for injection molded or extruded plastic components in medical devices, according to Foster.

Pigments used for device components that contact the human body, such as catheter tubing, require documentation to be submitted as part of device approval by the FDA. 

Foster said that use of pigments that have been previously evaluated for use in medical devices may reduce the FDA review time for a new device and expedite the approval process.

MediBatch colour concentrates are formulated using FDA 21CFR 73 Subpart D listed pigments and a polymer carrier that is compatible with a wide range of base resins, including nylons and polyurethanes.

Twelve standard concentrates, including green, red, yellow, blue, violet, black and white, are available from stock in one, five and ten pound quantities and Foster said that custom coloured concentrates are also available on a made to order basis.

Alicia Bergeron, regulatory, safety and environmental manager, Foster, said: “MediBatch colour concentrates were specifically created with medical device product development in mind.

“By using FDA 21CFR 73 Subpart D pigments and packaging in small quantities they are ideal for use in early stage development and prototyping operations.

“Single pound quantities available from stock can pigment up to 25 pounds of natural polymer and allow for engineers to rapidly prototype new components without the need to purchase large amounts of material.”