H.R. 3807: Medical Device Shortage Reduction Act of 2023

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.

Written by the Congressional Research Service, Library of Congress.