Medical Devices:

The Public Health at Risk

T-PEMD-90-2: Published: Nov 6, 1989. Publicly Released: Nov 6, 1989.

Additional Materials:


Office of Public Affairs
(202) 512-4800

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supporting their safety and effectiveness; (2) the FDA comparison base for determining substantial equivalence was outdated; (3) a statutory definition for substantial equivalence was needed; and (4) FDA had neither developed the mandated performance standards for medium-risk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.

Mar 23, 2018

Mar 19, 2018

Mar 8, 2018

Feb 20, 2018

Feb 8, 2018

Feb 5, 2018

Jan 30, 2018

Jan 23, 2018

Jan 17, 2018

Looking for more? Browse all our products here