USFDA BIOLOGICAL EVALUATION AND SAFETY ASSESSMENT OF MEDICAL DEVICES

Abstract

In this paper, I will give an extensive account of the regulatory process governing the food and Drug administration (FDA) of United States; dealing with the safety, efficacy, and quality control of the medical devices. It draws the reader’s attention to the history of the regulation of using medical devices with references to such legislations as Medical Device Amendments of 1976 and the FDA Safety and Innovation Act of 2012. The division of the devices according to the level of risks into Classes I, II, and III is mentioned, and the biocompatibility and safety testing with detailed description as provided in ISO 10993 portrays. The similarity between ISO 14971 corresponded to risk management procedures and ISO 13485 and cGMP to quality management systems in order to demonstrate regulatory stringency. Post-market surveillance processes are also discussed such as the MAUDE database and the 510 (k) / 522 pathways. In general, this paper supports the necessity of effective and changing regulation system to find the balance between medical innovations and the safety of population.