The FDA’s https://www.fda.gov FY 2022 budget request includes $21.6 million to develop a new Resilient Supply Chain and Shortages Prevention Program (RSCSPP) in FDA’s Center for Devices and Radiological Health (CDRH).
For the first time, FY 2022 budget funding would provide, resources to establish a permanent program for U.S supply chain resilience for medical devices.
The importance for a robust supply chain has been very evident during the COVID-19 pandemic since the U.S response relied upon having devices available such as PPE, ventilators, invitro diagnostic test, and the components necessary to run them plus other critical devices.
The RSCSPP will establish a permanent device shortages program to ensure that U.S patients and healthcare providers have access to critical medical devices that are needed and also help reduce the U.S. dependence on devices from other nations.
The RSCSPP will enable CRRH’s capacity to enable rapid intervention to prevent supply chain interruptions by:
- Developing proactive regulatory measures and partnerships with industry, healthcare providers, patients, and others
- Developing and applying state of the art supply chain intelligence for predictive modeling
- Establishing early signal detection and continuous surveillance
- Fostering a more resilient domestic supply chain via investments in preventive measures to help avert shortages before they occur
Also, the need for a resilient supply chain and shortages prevention program is needed when situations such as hurricanes and other natural disasters occur that may not rise to the level of a public health emergency but yet may disrupt device availability which could significantly impact patient care.