Analysis of variability in regulatory requirements for product approval, manufacturing, and post-market surveillance of human and veterinary medical devices in the United States

Clear differences in the way FDA regulates human and veterinary medical devices were noticed by the researcher during tenure as a Quality Assurance professional in the animal health industry. This prompted research which examined the differences in regulation of human and veterinary medical device pre-market clearance, manufacturing control, and post-market surveillance through the review of data describing the development of federal laws, authorized agencies, and regulatory methodologies applied to device regulation. The research methodology included the evaluation of identifiable gaps in regulation and qualitatively assessed risk to veterinary medical device safety and effectiveness relative to identifiable gaps. Multiple gaps were identified and the magnitude of risk to veterinary medical device safety and effectiveness, and impact to human safety, was established.