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, and 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.
Our 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, ISO 10993 is used as a basis for developing a biological test program.
Each device should be examined on its 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.
NOTE: This list provides an overview of tests that should be considered for urologic devices—our technical specialists and scientists will partner with you to develop specific, cost-effective test programs that minimize your time to market.