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Number 4
​Data REview

The starting material, formulation, processing variations, sterilization, packaging, shipping, and aging all have effects on the biocompatibility of the device.
During the data review the characterization of toxicological hazards as well as other biological reactions to medical devices.
General review of literature on toxicology data of materials  and test data from biological tests.
Testing should not be done if the risks are acceptable.  Testing should not be done if the risks are unacceptable.  Therefore testing should be done to answer the unanswered questions left by the chemical characterization and literature review.
A review of the testing results should be conducted.  Is the data sufficient.  It should document how the conclusion of acceptable risk was determined in a transparent, focused and precise manner and fully discussed.
Compounds that leach out of medical devices are rarely single entities and the  combination of compounds that exist could increase or decrease the toxicity of an individual chemical constituent.  Very rarely is there data available for chemical mixtures.
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  • Home
  • Suppliers
    • Contract Laboratories >
      • Toxikon
      • Nelson Labs
      • Eurofins
    • Material Suppliers
    • Contract Manufacturers
    • Consultants >
      • Intrinsic Medical Group
  • Library
    • Which Endpoints Should I Consider?
    • Test Method Summaries
    • White Papers, Articles and Presentations >
      • FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires
      • FDA Recognized Consensus Standards Update
      • The Ten Steps of a Biological Evaluation whtin a Risk Management Process
      • Post-Approval Biocompatibility
      • The Failed Cytotoxicity Test
      • Biocompatibility Deficiency Letters Part 2
      • ISO 18562-1 (2017) Biocompatibility Evaluation of Breathing Gas Pathways
      • In-Vivo Thrombogenicity 101
      • Technical Considerations for Additive Manufactured (3D Printed) Devices
      • How to Pick a Biocompatibility CRO
      • Mitigating Risk in Biocompatibility
      • Biocompatibility Deficiency Letters
      • The First Steps in Biocompatibility
  • Contact
    • About
  • Search