Summary

GAO discussed its work on the Food and Drug Administration's (FDA) premarket review and postmarket surveillance systems for medical devices. GAO noted that FDA premarket reviews remained inadequate because: (1) FDA judged most medical devices to be substantially equivalent to pre-1976 devices and approved them without direct evidence supporting their safety and effectiveness; (2) the FDA comparison base for determining substantial equivalence was outdated; (3) a statutory definition for substantial equivalence was needed; and (4) FDA had neither developed the mandated performance standards for medium-risk devices nor implemented premarket approval requirements for pre-1976 high-risk devices. GAO also noted that the FDA postmarket surveillance system needed improvement because: (1) a study involving 10 hospitals showed FDA was aware of less than 1 percent of device problem occurrences, because most reports went to manufacturers or intermediaries and were mostly oral reports; (2) the hospitals' compliance with new FDA reporting regulations could not be established; (3) FDA processing and analysis of device problem reports were inadequate; and (4) FDA had no control over the product recall process.