Recently, the US Food and Drug Administration (“FDA”) Center for Devices and Radiological Health (“CDRH”) published guidance describing how medical device manufacturers should notify CDRH of shortages during the pandemic. This is a new reporting requirement for medical device manufacturers, as they are generally not required to report shortages. However, the Coronavirus Aid, Relief and Economic Security (“CARES”) Act included a provision requiring medical device manufacturers to report supply interruptions or permanent discontinuations for critical devices due to the ongoing public health emergency.
The guidance discusses the following topics:
Who Must Notify CDRH: Medical device manufacturers that are subject to the new reporting requirement are those that manufacture devices that are critical to public health, including those devices that are used in life-supporting or life-sustaining applications, or intended for use in emergency medical care or surgery. Examples of such medical devices are ventilators, hemodialysis equipment, automatic external defibrillators, cardiopulmonary bypass oxygenators, specimen collection kits, reagents for serological testing, and pulse oximeters and other monitoring equipment.
When to Notify FDA: Medical device manufacturers subject to this reporting requirement must notify CDRH 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 is practicable and not later than 7 days after the discontinuance or interruption in manufacturing.
What Information to Include in Notifications: Manufacturers are required to notify the CDRH of the permanent discontinuance or interruption in manufacturing, as well as the reasons for such discontinuance or interruption. 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. Manufacturers are also encouraged to submit additional information that will enable CDRH to work effectively with other manufacturers and entities to mitigate the negative impact on patients and healthcare providers. This additional information includes, for example, whether the device is manufactured on multiple lines or in multiple facilities, the amount of device inventory on hand, whether the manufacturer has provided information to stakeholders and patients about the shortage, and whether the manufacturer has shortage mitigation plans.
How to Notify FDA: 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.
The notification requirement will continue for the duration of the COVID-19 public health emergency.