Study Clinical Trials of Medical Device by FDA Bioresearch Monitoring (“BIMO”) program

FDA Bioresearch Monitoring (“BIMO”) program are to protect the rights, safety, and welfare of human research subjects and to assure the quality, reliability, and integrity of data collected. It is a good source to learn good clinical practice, responsibilities of sponsors, clinical investigators, contract research organizations, monitors, institutional review boards in clinical trials of medical devices and preparing for FDA inspections. 

FDA Launches Online National Medical Device Curriculum

FDA has launched a new learning tool for academic institutions and science and technology innovators called the National Medical Device Curriculum, to advance their understanding of FDA's medical device regulatory processes. The curriculum offers students FDA-endorsed knowledge about navigating the regulatory process, including how to design, test, and clinically evaluate devices; identify the root causes of adverse events and device malfunctions; and develop iterative device designs. The curriculum includes a series of four fictional case studies based on real-world medical device scenarios in a format similar to Harvard Business School Case Studies. 

By understanding FDA's regulatory process, innovators can accelerate the delivery of innovative medical products to patients.