Standards used in meeting requirements for a model pre-market approval (PMA) of a neural guidance conduit

A hypothetical neural guidance conduit, 'InnervTube,' employing autologous denatured muscle is presented in the form of a PMA as an example of how existing standards for tissue engineered medical products are used in product testing and evaluation. The performance requirements that determine the specific device characteristics are defined, along with a proposed method of manufacture, use, and control. Alternatives, contraindications, and preliminary in-situ and in-vitro results garnered from the literature are presented.