How do the GLPs apply to the testing of electromechanical medical devices (non-animal work)?
It is presumed that the question refers to engineering tests and in vitro tests of such devices conducted to assess functionality. In these cases, the GLPs do not apply. 14. Please elaborate on the preamble statement (43 FR 59989) that studies involving “diagnostic products” and “medical devices, which do not come in contact with or are implanted in man” are not within the scope of the GLPs. Failure of diagnostic products or medical devices, which do not come in contact with man or are not implanted does pose a safety hazard. This is also true for implantable devices. Tests to establish the reliability of these articles are functionality tests, not safety tests. The GLPs cover implantable devices, which may cause adverse tissue reactions or may have components, which leach into the tissues and cause a toxic response. 15. Is an in vitro study to quantitate the amounts of residual proteolytic enzyme on a soft contact lens (the enzyme is used to clean the lens) a safety study which is cov
