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Colorants in Devices: Successfully Integrated Strategies Towards Regulatory Approval
October 6, 2015 @ 11:00 am - 12:00 pm
Sign up below for our Colorants webinar. 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