| The U.S. Food and Drug Administration's Devices Program is responsible for the regulation and oversight of a wide range of medical devices that patients and their health care providers use every day. These devices range from simple tongue depressors to complex instruments that help save and sustain life, such as heart valves, the artificial pancreas, and programmable pacemakers with micro-chip technology. 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 high-quality medical devices. One such action was implementation of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which was signed into law on March 27, 2020, and gave the FDA, for the first time, statutory authority intended to help prevent or mitigate device shortages during, or in advance of, a public health emergency. However, the pandemic has exposed great weaknesses in the medical device supply chain and its dependence on foreign medical devices. To ensure the U.S. 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 FDA recognizes that this will take resources and expanded authority. The investments outlined in the FDA's FY 2022 budget include $21.6 million for a new Resilient Supply Chain and Shortages Prevention Program in the Center for Devices and Radiological Health. This funding will provide, for the first time, resources to establish a permanent program for U.S. supply chain resilience for medical devices. |
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