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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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.

GAO found that: (1) prior to implementation, FDA received about 2,500 problem reports annually through voluntary reporting; (2) during the first 3 years after MDR implementation, FDA received about 18,000 problem reports annually; (3) there was a significant increase in the proportion of deaths or serious injuries that were concentrated among relatively few medical specialities and devices within those specialities; and (4) 10 medical devices accounted for about 63 percent of all reported problems and cardiovascular devices accounted for about 50 percent of all reported problems. GAO also found that the: (1) MDR system lacked procedural guidelines for report analysts; (2) report analysts lacked automated data processing skills; (3) work-flow pattern for MDR processing was unnecessarily complicated; (4) system had a limited capacity to identify trends and anomalies in the device problems; (5) volume and types of reports submitted resulted in a constant backlog, including more than 10,000 malfunction reports for which FDA had not completed some portion of analysis; (6) FDA did not close about one-third of the MDR reports with one of the standard report dispositions and closed about 62 percent of the reports for use as baseline data; (7) FDA tentatively identified the cause of device problems in half of the reports it evaluated and found that the device was the cause in 77 percent of those reports; (8) FDA did not use the data for purposes other than to record and track device problems and had very little data on its corrective actions; and (9) one-third of the device firms FDA inspected were not aware of the MDR rule and 37 percent received no problem reports about their devices.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: P.L. 101-629 legislated this recommendation on November 28, 1991.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Not Implemented

    Comments: According to the agency contact, HHS did not concur with this recommendation and, therefore, plans no action.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  3. Status: Closed - Implemented

    Comments: P.L. 101-629 contained a provision that gives FDA the authority to promulgate new regulations to address this recommendation.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services


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