USER REPORTING UNDER THE SAFE MEDICAL DEVICES ACT OF 1990

The enactment of the Safe Medical Devices Act of 1990 will have an impact on clinical laboratory professionals. A section of the Act will require medical device user facilities to report serious medical device problems to the manufacturer and/or the Food and Drug Administration. In vitro kits, including immunoassays and associated instrumentation, are considered to be medical devices. Information on the user reporting sections and additional sections of the Act are described.