New FDA Supply Chain Program Aims To Prevent Device Shortages
The new program will be the focus of the agency’s June workshop
Executive Summary
The US Food and Drug Administration is building a new Resilient Supply Chain Program, which aims to bolster the nation’s supply of essential medical devices and prevent future shortages.
You may also be interested in...
FDA Introduces ‘Proactive‘ Resilient Supply Chain Program To Reduce Future Device Shortages
The US FDA’s Resilient Supply Chain Program (RSCP) will be housed in the agency’s Office of Strategic Partnerships and Technology Innovation and aims to reduce future supply chain shortages by applying lessons learned during the pandemic.
Medtronic Starts Planned Portfolio Simplification With DaVita Renal Care Spin Off
The new independent kidney-care company will be equally co-owned by both companies. It will include all of Medtronic’s renal care solutions business, including renal access, acute therapies, and chronic therapies.
FDA Publishes Final Guidance On Clinical Decision Support Software, Clarifies What Software Should Be Regulated As Medical Devices
In its final document, the US FDA outlines its interpretations of the four criteria for excluding clinical decision support software from being regulated as medical devices under federal law. Software must meet all four criteria to be excluded.