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What type of surface contact will it have

Will it be on intact skin, on a mucosal membrane but not a route for fluids in or out of the body or in contact with a wound?
Is the device on healthy skin?  Will it be in contact with breached or compromised skin like a wound?  Or will it be in contact with a mucosal membrane?  This can be an area of contention.  Many products may appear to be mucosal membrane surface contacting products.  But their function is to deliver anesthesia or remove waste from the body.  In this function, they are externally communicating devices.
It will be on healthy skin
It will be in contact with a mucosal membrane
It will be in contact with a wound
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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