The Safe Medical Devices Act (SMDA) of 1990 requires healthcare facilities to report any medical device failures or malfunctions that result in serious injuries or death to the appropriate regulatory organization. Which organization is responsible for this act?

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FDA. Answer: FDA The FDA is responsible for the Safe Medical Devices Act (SMDA) of 1990, which mandates healthcare facilities to report device-related incidents that result in serious injury or death.

The Safe Medical Devices Act (SMDA) of 1990 requires healthcare facilities to report any medical device failures or malfunctions that result in serious injuries or death to the appropriate regulatory organization. Which organization is responsible for this act?

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