The Safe Medical Devices Act is a federal act signed into law in 1990 that mandates health providers to report deaths or injuries suspected to have been caused by medical devices to the FDA and the product manufacturer. According to Congress.gov, the bill was sponsored by Representative Henry Waxman in 1989 as H.R. 3095, and it was enacted into law as Public Law No. 101-629.Continue Reading
The Safe Medical Devices Act of 1990 amended the Federal Food Drug and Safety Act by adding the reporting requirement. According to Congress.gov, it applies to "medical device user facilities," which are defined to include hospitals, nursing homes, surgical facilities and outpatient treatment facilities that are not physician's offices.
According to the National Institutes of Health, device tracking by the FDA went into effect in 1993. The Federal Drug Administration outlines the process and forms that must be used at its website, where the medical device reporting regulation, codified as 21 CFR 803, can also be found. While user facilities are not required to report device malfunctions, they can voluntarily do so using form 3500 and submitting it to the FDA.
According to the FDA, the reporting requirements as mandated by the regulations apply manufacturers and importers of medical devices in addition to medical device user facilities.Learn more about Law