USA – US FDA to temporarily accept changes to devices approved through PMA or HDE

The US Food and Drug Administration (FDA) published a noteworthy new guidance document this month, “Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus 2019 (COVID-19) Public Health Emergency.” This reveals a temporary loosening of rules intended to assist medical device and IVD manufacturers confronting problems related to the COVID-19 pandemic, such as social distancing protocols in the workplace, supply chain disruptions, and decisions to move operations to regions with less exposure to the disease…