On May 21, 2020, the U.S. Food and Drug Administration (FDA) issued a guidance to help foster continued availability of medical devices during the COVID-19 public health emergency.
Per the guidance, during the COVID-19 public health emergency:
- The FDA does not intend to object to limited modifications to the design and manufacturing of devices approved through either a PMA or HDE without prior submission of a PMA or HDE supplement or 30-day notice for the duration of the public health emergency.
- The policy applies to limited modifications to approved HDEs or PMAs that would trigger the requirement that a manufacturer submit a PMA or HDE supplement or 30-day notice to the FDA . Some examples of these limited modifications may include immediate changes adjusting manufacturing processes to allow for social distancing, adapting manufacturing or design due to supply chain disruption, or moving device production to a region that is less impacted by COVID-19.
