COVID-Era Requirements for Changes to a Device Under PMA or HDE Extended by FDA

A new FDA guidance set to take effect immediately extends the agency’s COVID-era policies requiring supplementary submissions for certain modifications to a device approved under the premarket approval (PMA) or humanitarian device exemption (HDE) pathways.

The 8-page guidance, “Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions,” replaces “Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency,” which was issued to help address manufacturing limitations or supply chain disruptions during the pandemic.

The FDA, the new guidance says, “has continued to observe supply chain challenges and shortages of medical devices remain widespread.” Although this guidance has been revised to remove any expiration date for the enforcement policy, FDA intends to continue to monitor the situation and may make further revisions to the guidance, withdraw the guidance, or pursue other regulatory actions, as appropriate.”

Read the full guidance here.

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