FDA premarket review processes for high-risk medical devices

Medical devices: FDA should take steps to ensure that high -Risk device types are approved through the most stringent premarket review process.

Medical Device Reporting (MDR)

Medical Device Reporting (MDR) is the name of the Act that allocates control to the Food and Drug Administration to monitor results of medical devices in order to make sure that no adverse effects results to society. The FDA receives information on this account from all manufacturers, users, and importers of medical devices who, if they experience a problem, are obligated to report this problem to the FDA so that these problems can be treated directly. User Facilities (e.g., hospitals, nursing homes), moreover, are required to report these problems to both the FDA and the manufacturer. Even if the user facility only suspects a serious result to have occurred because of the device but is not certain, nonetheless, the suspicions should still be reported to both FDA and manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to the FDA.

The FDA urges that:

If you are a consumer or health professional you should use the MEDWATCH program for reporting significant adverse events or product problems with medical products (Medical Device Reporting - General Information www.rcb.ca.gov/forms_pubs/attach6.pdf)

History of Medical Device Reporting (MDR)

Manufacturers and importers of medical devices have been required since 1984 to report suspected shortfalls of medical devise to the relevant organizations but this has never seriously been followed through. A 1986 General Accounting Office (GAO) study showed that less than one percent of device problems occurring in hospitals were being reported to FDA, and that the more serious the problem with a device, the less likely it was to be reported. In 1989, a GAO follow-up study showed that serious lapses of reporting to FDA still existed. Incidents that involved device-related deaths, serious injuries, and certain malfunctions were still being seriously under-reported.

The Safe Medical Devices Act of 1990 (SMDA) obligated device user facilities to report device-related deaths to the FDA and to the manufacturer. On November 28, 1991, SMDA also required that device user facilities submit to FDA, every six months, a summary of all reports submitted during that time period. This Amendment became law on June 16, 1992, when the President signed the Medical Devices Amendments of 1992 (Public Law 102-300; the Amendments of 1992), amending certain provisions (section 519 of the Food, Drug, and Cosmetic Act) relating to reporting of adverse events. The Act was intended to clarify and reinforce certain earlier terms and to establish a single reporting standard for device user facilities, manufacturers, importers, and distributors. This Act was followed by a final follow-up in Federal Register on December 11, 1995 that addressed comments received in the interim by the FDA and the changes mandated by the Amendments of 1992.

The latest Changes on MDR

The Food and Drug Administration Modernization Act (FDAMA) that was signed on 11/21/97 introduced four changes that affected MDR. These are the following:

Manufacturers and distributors/importers do not need to submit annual certification.

Domestic distributors are no longer required to file MDR reports, but must continue to keep complaint files. [Importers (initial distributors for devices manufactured overseas and imported into the U.S.A.) must continue to file MDR reports.]

User facilities must now file an annual report instead of semiannual reports to summarize their adverse event reports.

Sentinel reporting by user facilities was proposed. (FDA - Medical Device Reporting (MDR) http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm).

These amendments came about due to the comments that the FDA invited in the interim of the amount of time between when the Bill was proposed to when it was actually passed.