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Medical Device Guardian’s Act Expands Adverse Event Reporting Requirement

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

Starting in 2019, under the newly introduced “Medical Device Guardian’s Act”, healthcare facilities, such as hospitals, nursing homes and outpatient treatment facilities will be required to report problems concerning medical devices to the FDA.

This bill which is co-sponsored by Congressman Mike Fitzpatrick and Congresswoman Louise Slaughter, representatives of Pennsylvania and New York respectively, will allow patients to become more aware of the potential risks associated with the medical devices they use, as well as help device manufacturers to understand some previously undiscovered side effects of the devices they develop.

The Medical Devices Guardian’s Act amends the Food, Drug & Cosmetic Act, which only required hospitals and medical device manufacturers to report adverse events, an occurrence that does not necessarily have a causal relationship with a particular treatment, to the Manufacturer & User Facility Device Experience Database, known as MAUDE. The amended act expands this requirement to other facilities that administer medical devices, allowing more information to be passed on to MAUDE concerning new adverse effects.

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