Devices that contact the reproductive organs, urethra, urinary bladder, ureter, rectum or kidney may be either externally communicating or implants. Typical devices in this category are dialyzers, catheters, condoms, stents, diapers or various types of implants to the bladder, uterus or Fallopian tube. Depending upon the end use of the device, it may be classified as mucosal contact, externally communicating tissue contact or an implant device. These devices are usually constructed of polymer or rubber materials, metal alloys, fabric or biological tissue.
NAMSA Technical Specialists and Scientists are adept at developing non-clinical testing programs based on international requirements. Veterinary surgeons on staff are available to plan and conduct biocompatibility and functionality studies that require surgical intervention.
Standards and Regulation
First consideration should be given to FDA guidance documents or ISO procedures already in place. For example, significant guidance exists for dialyzer reuse evaluations. In the absence of guidance or requirements, use ISO 10993 as a basis for developing a biological test program.
Each device should be examined on it's own merits. In some cases, prior data may be available from suppliers or in the literature, or there may be efficacy or functionality testing in progress that can be used to satisfy a portion of the safety requirements.
