ABSTRACT
Safe and effective Statutory criteria for a new drug a New Drug Application sponsor must meet before the application can be approved by the FDA.
Safe Medical Devices Act of 1990 US. law enacted in November, 1990 in which Congress gave the FDA additional powers to enforce the medical device laws, directing and enabling the agency to streamline procedures, obtain earlier and more comprehensive knowledge of serious device problems, remove defective devices from the market more quickly, exercise more options for product evaluation and classification, and provide greater assurance of the safety and effectiveness of new medical devices.
