Safe Medical Devices

HEHS-94-86R: Published: Feb 10, 1994. Publicly Released: Feb 10, 1994.

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Pursuant to a legislative requirement, GAO reviewed medical device users' compliance with the Safe Medical Devices Act's reporting requirements. GAO noted that: (1) the Food and Drug Administration (FDA) had not published the final regulation on reporting medical device problems as of January 1994; (2) FDA is implementing a new device-reporting system to replace its existing device-reporting systems, but few users are aware of the new system; (3) FDA has attempted to educate medical device users on the act's reporting requirements by distributing information about the reporting requirements at health care conferences; and (4) many users are unaware of their reporting responsibilities.

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