This bill expands the scope of required notifications about medical device shortages beyond public health emergencies.
Currently, manufacturers of medical devices that are critical during a public health emergency (e.g., devices that are life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery), or for which the Department of Health and Human Services (HHS) determines information about the supply chain is necessary during a public health emergency, must notify HHS of expected shortages of such devices. Manufacturers may voluntarily provide information on expected shortages of other critical medical devices, whether or not there is a public health emergency.
The bill expands these provisions so as to generally require manufacturers to notify HHS of expected shortages of critical medical devices, whether or not there is a public health emergency. It also requires manufacturers to develop risk management plans that identify potential risks to the supply chain of such devices.
