Colorants in Devices: Integrated Strategies Toward Regulatory Approval

A challenge common to all medical device manufacturers is conducting a regulatory submission which is both effective and efficient. Successful submissions with devices that utilize colorants are less likely to go off without a hitch. What exactly is the perspective of the FDA with regard to Colorants in Medical Devices? What testing is a Medical Device Manufacturer expected to conduct to support the use of a colorant in a medical device? What about the Colorant Manufacture’s Master File with the FDA… will that address testing requirements?

This presentation will provide answers to many of these inquiries and more. John Iannone from Toxikon Corporation will discuss the regulation of colorants in medical devices and present solutions to many of these challenges, therefore preparing you for the attainment of a successful regulatory submission. Discussion topics will include:

• What you need to know about USP Class VI(6) vs. ISO 10993
• Biocompatibility Testing considerations of colorized devices
• What information a Device Manufacture can obtain from the colorant manufacturer?
• Chemical Characterization of Materials as it applies to proprietary colorants
• Toxicology Risk Assessments of Colorized Devices
• FDA approved color additives for Medical Devices

Speakers

Mark Thomson, MBA, NA Sales & Marketing Manager, Arazy Group Consultants Inc.

Mark is a business consultant and sales & marketing expert with an extensive record of achievement within the global medical technology and healthcare services industry. Since 2013, Mark has been acting as North American Sales & Marketing Manager for Arazy Group Consultants Inc., helping medical and IVD device manufacturers around the world to successfully launch their products in multiple markets through Arazy Group’s flagship service LICENSALE.COM™.

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John Iannone, Program Manager – Extractables/Leachables & Special Studies, Toxikon

Since joining Toxikon in 2004, John has assisted several drug and medical device developers with the development of product safety testing strategies. His areas of expertise include biocompatibility testing of combination devices, material characterization, and study design for custom microbiological and extractable/leachable studies. His responsibilities focus on providing technical support in client interface regarding unique testing requirements and facilitating the attainment of sound technical risk assessments of medical devices.

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