Zdrowie i gospodarka · 19/05/1997

FDA Establishes Procedures for Reporting Corrections and Removals of Medical Devices

The FDA is issuing a final rule to require manufacturers, importers, and distributors to report promptly any corrections or removals of medical devices to reduce health risks or remedy violations of the Federal Food, Drug, and Cosmetic Act, aiming to protect public health and improve the agency's ability to evaluate device-related problems.