USA – FDA issues guidance on PMA, HDE supplements amid COVID-19

The US Food and Drug Administration (FDA) on Thursday issued an immediately effective guidance allowing medical device makers to make “limited modifications” to their devices without submitting a premarket approval (PMA) or humanitarian device exemption (HDE) supplement or a 30-day notice during the coronavirus disease (COVID-19) public health emergency.

FDA says the policy is meant to give device makers additional flexibility to address supply chain issues stemming from material or component shortages or facility closures due to COVID-19-related disruptions.

“Due to these and other COVID-19 related developments, numerous manufacturers may need to make immediate changes such as adjusting manufacturing processes to allow for social distancing, adapting their manufacturing or design due to supply chain disruption, or to moving device production to a region that is less impacted by COVID-19,” FDA writes…