On April 22, 2020, the U.S. FDA provided updated instructions to the import community regarding the submission of entry information for personal protective equipment (PPE) and certain other medical devices with the aim of facilitating the import process for products related to the COVID-19 public health emergency. Due to the rapidly evolving COVID-19 situation, we expect that these instructions will be updated periodically, particularly as the FDA issues new Emergency Use Authorizations (EUAs) for imports of PPE and revises existing EUAs. As a result, importers of PPE should closely monitor these instructions and the FDA’s listing of EUAs for updates. McGinnis Lochridge is working closely with foreign manufacturers and importers of PPE, and we are available to provide an array of legal and regulatory services to companies entering the U.S. PPE and medical device market in response to the COVID-19 crisis.
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