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FDA Issues Guidance on Medical/Dental Device Supply Chain Vulnerabilities
Per the notice below, the United States Food and Drug Administration (FDA) has issued guidance on medical/dental device supply chain vulnerabilities and their impact on patients.
Medical Device Supply Chain Vulnerabilities and the Public Health Impact They Have on Our Most Vulnerable Patients
A critical focus of the U.S. Food and Drug Administration (FDA) is preventing and mitigating potential medical device shortages. From ventilators and neonatal breathing tubes to hemodialysis catheters, the scarcity of these critical devices poses a growing threat to patient care—especially for our youngest and most vulnerable populations. For pediatric patients, medical device shortages are uniquely challenging. From premature infants in neonatal intensive care units to children with chronic illnesses requiring long-term medical interventions, the need for appropriately sized, high-quality devices is paramount. Today the FDA’s Center for Devices and Radiological Health issued a statement on medical device supply chain vulnerabilities, the public health impact they have on patient care, the FDA’s actions to prevent and mitigate potential shortages, and solutions to strengthen the domestic supply chain and address these vulnerabilities.
Questions?
If you have questions about this statement, contact the Division of Industry and Consumer Education. The FDA is interested in hearing from health care facilities and providers that may be having difficulty obtaining medical devices, as well as from other interested parties who may be impacted by potential shortages. Please e-mail the FDA at: deviceshortages@fda.hhs.gov.
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