The agency also wants notifications to include "production volume information to help facilitate conducting fuller oversight of supply chain disruptions," Woodcock said, and to have the power to make manufacturers develop and share risk management plans. experienced supply disruptions before facing its own public health emergency.įDA wants the power to obtain supply disruption notifications for critical devices whenever there is the potential for a shortage, regardless of whether the U.S. "The temporal limitation and tie to public health emergencies for manufacturers to submit device shortage notifications puts the FDA behind in responding to early signs of supply constraints or a potential shortage," she noted.ĬOVID-19 outbreaks abroad meant the U.S. The acting FDA commissioner cited differences between FDA’s powers related to drugs and devices to make the case for expanded authority. The FDA recognizes that this will take resources and expanded authority," Woodcock wrote in the blog post. is properly prepared now, and in the future, we must take action to secure our medical device supply chain, including related materials, parts, and components. "The pandemic has exposed great weaknesses in the medical device supply chain and its dependence on foreign medical devices. Yet, Woodcock also sees opportunities to improve the response to future crises. Woodcock hailed areas she thinks FDA did well, such as the awards of EUAs to 13 decontamination systems for personal protective equipment to ease supply constraints on face masks and other devices needed to protect healthcare professionals from the coronavirus.
The changes led FDA to prioritize devices that could help address significant shortages.
To help manage the workload, FDA revised its EUA review processes to "incorporate the latest information on device availability and shortages." The volume of COVID-19 emergency use authorization requests for medical devices quickly rose to "two orders of magnitude" higher than the peak of any previous public health emergency, Woodcock said in the hearing testimony. At that meeting, Woodcock described the work FDA did to ensure the supply of medical devices during the pandemic. America is running out of everything because Americans are buying so much stuff.Woodcock's statement setting out the need for more money and powers comes a day after giving testimony to the Senate Committee on Health, Education, Labor, and Pensions. America isn't running out of everything just because of a supply-chain crisis.After pumping $11 billion into e-commerce in 5 years, VCs are finally funding the risky warehousing startups they've been avoiding.The untold story of how Amazon siphoned FedEx talent, setting Amazon Logistics up to soar while FedEx flounders.She started her journalism career as a financial reporter in Beirut, Lebanon. She was a freelance food industry reporter for several years with bylines in The Atlantic, The Counter and Edible Manhattan Magazine. She previously covered supply chains and food and agriculture technology for Supply Chain Dive and AgFunder News. From warehouse technology to delivery labor, she tries to spread a deeper understanding of the people and systems that bring goods to our doorsteps with ever-increasing speed. She covers logistics with a focus on e-commerce. Emma Cosgrove is a senior reporter on Insider's transportation team.