Colorants in Devices: Successfully Integrated Strategies towards Regulatory Approval

Life Sciences, Pharmaceutical Regulation, Pharmaceutical, Medical Device, Medical Device Safety and Regulation,
  • Tuesday, October 06, 2015

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


John Iannone, Program Manager/Technical Specialist, Extractables/Leachables & Special Studies, Toxikon Corporation

John Iannone has a Background in Biomedical Engineering from Boston University, where he later became a research engineer. In 2004, he joined Toxikon and has assisted numerous drug and medical device manufacturers with the development of product safety testing strategies. His areas of expertise include biocompatibility testing of combination devices, drug delivery systems, chemical characterization, and study design for customized extractable/leachable studies to ensure the attainment of sound technical risk assessments for medical devices and Pharmaceutical container systems. John has given numerous technical presentations and has lead several workshops on the topic of Extractables & Leachables, Biocompatiblity, HAIs, Biomaterials, and regulatory testing requirements for Combination Products. John also participates in the development of regulatory guidances, such as the ISO 10993 guidelines and USP chapters pertaining to Biological Reactivity/Biocompatibilty. Additional responsibilities include providing technical support to clients regarding unique and global testing requirements to meet the US, Canadian, European, and Asian regulatory expectations and requirements.

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Who Should Attend?

Senior level executives involved in regulatory affairs for medical device companies, including those from manufacturing services providers, consulting companies, product development, and financial/investment companies and government.

Relevant job functions include:

  • Engineering – Biomedical, Design, Manufacturing/Production, Packaging, Process, Project, Quality, R&D
  • Manufacturing (Packaging, Process)
  • Project Management
  • Research & Development
  • Regulatory / Compliance / Quality Assurance
  • Sales / Business Development / Marketing
  • Purchasing

The session will also benefit pharmaceutical, biotechnology and dental product manufacturers.

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Toxikon is a Contract Research Organization (CRO), with ISO/IEC 17025 accreditation that is registered with the US FDA and Japanese MHLW for drug and medical device testing. The Company provides in-vivo, in-vitro, and analytical testing services for the Pharmaceutical, biotechnology, and medical device sectors. Toxikon’s safety services include biocompatibility, toxicology (acute, subchronic, and chronic toxicity, reproductive toxicity, genetic toxicology, carcinogenicity, and risk assessment), pharmacokinetics, toxicokinetics, bioavailability, ADME, chemical characterization, Extractables/Leachables Testing, impurities analysis and synthesis, bioanalytical, and microbiology.

Toxikon was founded in 1982. The Company has two primary locations: headquartered in Bedford, MA within a multi building campus comprised of 117,000 square feet of state-of-the art facilities and an additional 20,000 (confirm this number with Lax and/or Tim) square feet European lab operation in Leuven, Belgium. Toxikon’s laboratory facilities are fully accredited including GLP/GMP registrations, and the Bedford facilities have full USDA, OLAW, and AAALAC animal testing credentials. In addition, both facilities are ISO accredited, enabling GLP and non-GLP work across both facilities. The company currently has approximately 80 animal rooms, and has impressive and extensive surgical suites that are fully equipped to provide efficacy and surgical research, along with in-house support with histology and clinical pathology activities and assessment. Toxikon currently serves over 1,000 active customers across the Pharmaceutical, biotechnology and medical device sectors through-out the world.

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