The US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) published a guidance describing how medical device manufacturers should notify CDRH of shortages during the COVID-19 emergency.

This is a new reporting requirement for medical device manufacturers, as they are generally not required to report shortages. The notification requirement will continue for the duration of the COVID-19 emergency.

Keypoints of the guidance:

•  Manufacturers of devices critical to the public health such as ventilators, hemodialysis equipment, automatic external defibrillators, cardiopulmonary bypass oxygenators, specimen collection kits, reagents for serological testing, and pulse oximeters and other monitoring equipment.
• CDRH must be notified at least six months in advance of a permanent discontinuance or interruption in manufacturing of a device that is likely to lead to a meaningful disruption in supply in the US. If that timeline is not realistic, that manufacturer should notify CDRH as soon as possible and not later than 7 days after the discontinuance or interruption in manufacturing.
• Permanent discontinuance or interruption in manufacturing, as well as the reasons for such discontinuance or interruption must be notified to the CDRH. Manufacturers should also include appropriate identifying information, including marketing submission holder name, marketing submission number, manufacturer name, FDA establishment identifier, device name, product code and contact information.
• Notification should be submitted via email to the CDRH. An initial notification may include a list of all affected devices. If an additional device is affected after the initial notification, and new notification should be submitted to the FDA.

For more details, please see the guideline from FDA.