Shortages of medical devices can occur for many reasons, including manufacturing and quality problems, geopolitical issues, natural disasters, delays, public health emergencies (PHEs), and discontinuations.
The Office of Supply Chain Resilience (OSCR), in the CDRH Office of Strategic Partnerships & Technology Innovation (OST), is responsible for managing the FDA’s activities to anticipate and prevent disruptions to supply chains for medical devices. OSCR is also responsible for maintaining an up-to-date medical device shortage list.