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.
Specifically, FDA says it does not intend to object to modifications made to address a manufacturing limitation or supply chain issue without prior submission of a PMA or HDE supplement or 30-day notice, so long as the modification does not create an undue risk. The policy also extends to certain modifications that that would normally require a 180-day or real-time PMA supplement or a 75-day HDE supplement, such as changes in performance or design specifications, circuits, components or the physical layout of a device.
FDA notes that the policy does not apply to changes made to PMA or HDE devices that are unrelated to manufacturing limitations or supply chain issues caused by COVID-19 and do not extend to changes that have already been included in submissions to the agency.
The guidance includes a list of modifications that would typically require a supplement or notice that would generally be allowable under the policy, as well as a list of changes it says would create an undue risk and would not be allowable without prior submission of a PMA or HDE supplement or notice.
FDA says that all manufacturing and design changes must comply with quality system regulations and that device makers must document changes in their device master record and change control records. FDA also recommends that device makers include a description of the modifications in their next report.
FDA