FDA issues Guidance on Approved Premarket Approval or Humanitarian Device Exemption Submissions

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/supplements-approved-premarket-approval-pma-or-humanitarian-device-exemption-hde-submissions-during?utm_campaign=2020-05-26%20FDA%20issues%20Guidance%20on%20Approved%20Premarket%20Approval%20or%20HDE%20Submissions&utm_medium=email&utm_source=Eloqua

Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyGuidance for Industry and Food and Drug Administration StaffMAY 2020