May 04, 2022 at 03:56PM Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)

This policy allows certain modifications to the design and manufacturing of previously approved PMA and HDE devices during the COVID-19 pandemic.

via Whats New Vaccines Blood Biologics RSS Feed https://ift.tt/0Y9TXak