In light of the widely reported shortage of personal protective equipment (PPE), ventilators, and other medical devices, the U.S. Food and Drug Administration (FDA) is working around the clock to authorize medical supplies for the US healthcare system, including relaxing its rules for importing and distributing PPE and ventilators and their accessories (e.g., vent splitters for multiple patient ventilation). FDA’s policies on permitting uncleared medical devices shift daily toward greater relaxation of regulatory hurdles for suppliers and manufacturers. The most recent policies on PPE importation and use in healthcare settings create more options for healthcare providers and patients in need of ventilatory support and help alleviate bottlenecks of necessary medical supplies in the supply chain.
Continue Reading Personal Protective Equipment & Ventilators: How FDA Is Increasing Supply for the US Healthcare System
Reid Whitten
Reid is the Managing Partner of Sheppard Mullin's London office, practicing in international trade regulations and investigations.
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