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Medical Devices: FDA's Implementation of the Medical Device Reporting Regulation

PEMD-89-10 Published: Feb 17, 1989. Publicly Released: Mar 20, 1989.
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Highlights

In response to a congressional request, GAO examined the Food and Drug Administration's (FDA) implementation of the medical device reporting (MDR) regulation to: (1) determine the level of information the regulation generated; (2) describe and assess the principal organizational structures and procedures that FDA used to process MDR reports; (3) evaluate FDA analysis and use of MDR data; and (4) review FDA efforts to assess the degree to which medical device firms complied with the MDR requirements.

Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Department of Health and Human Services The Secretary of Health and Human Services should require all firms that manufacture or import medical devices to submit an annual statement indicating either that they filed no MDR reports during the calendar year because they did not receive or otherwise become aware of information concerning MDR-reportable events, or that they filed a specific number of reports on each type of reportable event and that the firm received or became aware of information concerning only these events.
Closed – Implemented
P.L. 101-629 legislated this recommendation on November 28, 1991.
Department of Health and Human Services The Secretary of Health and Human Services should ensure that FDA completes a methodologically sound program of MDR compliance inspections that would permit valid generalization of the results to the population of device manufacturers and importers.
Closed – Not Implemented
According to the agency contact, HHS did not concur with this recommendation and, therefore, plans no action.
Department of Health and Human Services The Secretary of Health and Human Services should encourage FDA to continue to strengthen its documentation of the use of MDR data in taking corrective actions on device problems, especially by ensuring that such actions are recorded in the MDR database.
Closed – Implemented
P.L. 101-629 contained a provision that gives FDA the authority to promulgate new regulations to address this recommendation.

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Topics

Consumer protectionFood and drug lawManagement information systemsMedical equipmentMedical information systemsMedical suppliesNoncomplianceProduct safetyReporting requirementsSafety standards