Resilient Supply Chain Program for Medical Devices
The mission of the Resilient Supply Chain Program (RSCP) for medical devices is to strengthen public health supply chains by proactively monitoring, assessing, and communicating risks and vulnerabilities to prevent shortages of medical devices.
Preventing and Mitigating Supply Chain Interruptions
The RSCP has been established to enhance the FDA’s capacity to prevent and mitigate supply chain interruptions and promote resiliency in the U.S. medical device supply chain to promote availability of safe and effective medical devices for patients by:
- Developing strategies, analyses, and informational products to prevent and, when appropriate, mitigate medical device supply chain disruptions and shortages
- Identifying supply chain risks and providing actionable information on those risks to medical device manufacturers, medical device distributors, health care delivery organizations, patients, health care workers, and government partners
- Developing communication channels across the medical device ecosystem to enhance collaborations for development of prevention and risk reduction strategies
- Collaborating with government partners and medical device stakeholders to triage supply chain disruption and/or shortage signals, determine potential impacts, and provide public health information to support an informed response
COVID-19 Public Health Emergency
Throughout the COVID-19 public health emergency, the FDA has taken many actions to help ensure that patients and health care providers have timely and continued access to safe and high-quality medical devices, including:
- Implementing new shortage authorities granted under the Coronavirus Aid, Relief, and Economic Security Act (CARES) Act.
- Maintaining a public medical device shortage list.
- Performing shortage assessments on signals from manufacturers, distributors, and other governmental partners, for medical devices such as:
- Personal protective equipment (PPE),
- COVID-19 testing supplies and equipment,
- Ventilators and other related devices.
- Reaching out to device manufacturers, health care delivery organizations, health care providers and distributors to assess supply chain vulnerabilities.
- Collaborating with government partners to inform the Federal government response to supply chain challenges and inform U.S. government decisions to promote domestic production of medical devices.
- Serving as a clearinghouse for testing supply alternatives to help increase the availability of tests for COVID-19.
- Fact Sheet: Mitigating and Preventing Medical Device Shortages and Prioritizing Public Health
- Medical Device Supply Chain Notifications During the COVID-19 Pandemic
- Medical Device Shortages During the COVID-19 Public Health Emergency
- Contact the FDA About a Medical Device Supply Chain Issue
- Virtual Public Workshop - Building Medical Device Supply Chain Resilience: A Healthcare and Public Health Ecosystem-Wide Collaboration - June 7-9, 2022