Lexology May 26, 2023
Welcome to FDA Regulatory News and Trends, designed to help you identify significant legal developments and navigate the evolving business, legal and regulatory world.
Updated FAQ on medical device shortages to reflect the end of the COVID-19 public health emergency.
- On May 12, 2023, FDA/CDRH updated its Supply and Shortages of Medical Devices: Frequently Asked Questions to address changes to requirements created during the COVID-19 pandemic, now that the public health emergency (PHE) has ended.
- During the pandemic, CDRH implemented several policy changes to help navigate medical device shortages – for example, the acceptance of Emergency Use Authorizations for COVID-19-related products.
- The recent update to the shortages FAQ revises several existing answers to reflect that the PHE and related...
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