February 23, 2022
The US Food and Drug Administration has published new guidance on reporting and notification requirements to better mitigate supply disruptions when medical device manufacturers cease or suspend production during public health emergencies.
The new guidance stems from legislation signed into law in March 2020 granting new authority to FDA to prevent or mitigate medical device shortages preceding or during public health emergencies such as COVID-19. Manufacturers of devices identified in the guidance must notify the agency either when they permanently discontinue manufacturing those devices or when a manufacturing interruption occurs that could potentially cause supply disruptions of those devices in the US during a public health emergency. The guidance covers policies regarding these manufacturers’ notification requirements and obligations in the event of a discontinuation or disruption.
Which manufacturers must notify FDA?
FDA identifies two key types of devices for which manufacturers are required to submit notifications to the agency in case of permanent discontinuance or interruption:
- Devices that are life-supporting, life-sustaining or intended for use in emergency medical care settings
- Devices for which data is deemed necessary by FDA related to potential supply disruptions during or before a public health emergency
FDA will determine which specific device types fall under notification of discontinuance or disruption based on specific public health emergencies as they develop; devices identified as critical during the COVID-19 emergency, for example, may not be considered critical in other public health emergencies.
Key information to include in notifications to FDA
Medical device manufacturers affected by FDA notification requirements in the context of a public health emergencies will need to meet the following criteria and deadlines, according to the guidance:
- Manufacturers planning permanent discontinuance of devices must report to FDA six months in advance or as soon as practically possible, but no later than seven days following a decision to permanently discontinue a device.
- Manufacturers experiencing or anticipating interruptions should notify FDA no later than seven days after occurrence of an interruption.
Although notification of discontinuance or disruption will essentially mean a new reporting requirement for manufacturers whose devices are identified as crucial for specific public health emergencies, these new requirements should provide FDA a clearer view of device supply chains in order to address shortages and prioritize premarket reviews of similar products to protect public health.
Learn more about US FDA medical device regulations at Emergo by UL:
- US FDA 510(k) consulting for medical device and IVD companies
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