S. 3477

Planning, Reporting, and Enabling Voluntary Expansion of Notifications Targeting Medical Device Shortages Act of 2022 or the PREVENT Medical Device Shortages Act of 2022

This bill expands existing requirements for manufacturers of certain medical devices to alert the Food and Drug Administration (FDA) of supply disruptions and addresses related issues.

Under this bill, a manufacturer of a medical device that is critical to public health during a declared public health emergency must notify the FDA as soon as practicable of any circumstance that is likely to lead to a meaningful disruption to the supply of the device in the United States. Currently, the manufacturer is only required to notify the FDA of supply disruptions stemming from manufacturing issues.

The bill also authorizes the FDA to receive notifications from manufacturers of medical devices that are critical to public health about manufacturing issues that are likely to lead to a meaningful disruption to the U.S. supply of the device.

Each manufacturer of a medical device that is critical to the public health must develop and implement a redundancy risk management plan in each manufacturing facility for the device. Such a plan shall be subject to FDA inspection.