§356j Discontinuance or Interruption in the Production of Medical Devices

Summary

Manufacturers of medical devices that are critical in a public health emergency—like life-support, life-sustaining, or devices used in emergency care or surgery—or any device the Secretary says needs monitoring, must tell the Secretary if they plan to stop making the device permanently (unless it’s because of an approved change) or if they expect a manufacturing interruption that is likely to cause a meaningful drop in supply in the United States. They must give this notice at least 6 months before the stoppage or interruption, or as soon as they can if 6 months is not possible. The Secretary will share reported information with doctors, hospitals, patient groups, and supply partners when appropriate, but can withhold details if sharing would harm public health (for example, by causing hoarding). Trade secrets and legally protected confidential information cannot be disclosed. If a manufacturer fails to notify, the Secretary will send a letter. The manufacturer then has 30 calendar days to explain and provide the required information. The Secretary will post the letter and response online within 45 calendar days, with confidential parts redacted, unless the Secretary finds the notice was issued in error or the manufacturer had a reasonable excuse. If a shortage is likely, the Secretary may fast-track reviews or inspections for devices or manufacturers that could help fix the shortage. The Secretary must keep a current public list of devices in shortage. Each listing will show the device name or category, makers, the reason for the shortage (one of eight types, such as manufacturing practice problems, regulatory delays, part shortages, discontinuance, shipping or sterilization delays, demand increases, or facility closure), and the Secretary’s estimate of how long the shortage will last. The Secretary can accept voluntary notices from manufacturers about planned stoppages or interruptions for critical devices. This summary does not change the Secretary’s authority, as of March 27, 2020, to speed device reviews or use emergency authorization powers. Definitions: “meaningful disruption” = a production change likely to cause more than a small reduction in supply and affect the maker’s ability to fill orders (does not include brief routine maintenance or short pauses expected to end within 6 months, certain component interruptions that do not cause a device shortage, or interruptions that don’t reduce procedures for multi-use devices); “shortage” = when demand or projected demand in the U.S. is greater than supply.