Helping the FDA expedite regulatory review
FDA approval processes comprise numerous steps to ensure the safety and efficacy of new drugs, devices, and therapies. Navigating the process can be complex and time-consuming, and as a result, the FDA is proactively looking for methods to accelerate the pace of review.
Initiated in 2021 by the FDA’s OCET office through a contract to SGT, the
program is a collaboration with the Center for Devices and Radiological Health (CDRH) to provide the FDA with access to Siemens’ Xcelerator portfolio, including advanced integrated software capabilities for design control and risk management, product lifecycle management, product, plant, and process design modeling and simulation, manufacturing execution, closed loop quality management, Industrial Internet of Things (IIoT), and much more.
The opportunity at hand is to truly explore the “art of the possible” and evaluate smart design and manufacturing processes of medical devices, such as ventilators and personal protection equipment, to improve performance, speed regulatory review, reduce supply shortages and increase supply chain resilience.
“The FDA is focused on developing standards, metrics and data needs for the use of advanced digital design and manufacturing technologies,” said FDA Chief Scientist Rear Adm. Denise Hinton. “Furthering the adoption of these new technologies can help increase U.S. manufacturing capacity, increase supply chain resilience, decrease time to market for medical diagnostics, therapies and vaccines that are needed for public health emergency response.”
The contract between Siemens and the FDA will last for several years as new use cases are developed and implemented. In addition to showcasing the potential of advanced digitalization and factory automation within life sciences, the contract will help the FDA better understand the processes and technologies that inform industry guidance, develop new regulatory frameworks, and prepare for potentially disruptive changes to design and production norms, such as those experienced with the SARS-CoV-2 virus.