Updated Final Guidance on PMA and HDE Supplements During the COVID-19 Pandemic

U.S. Food and Drug Administration sent this bulletin at 05/04/2022 10:10 AM EDT

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FDA - Center for Devices and Radiological Health

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FDA Updates Final Guidance on PMA and HDE Supplements During COVID-19 Pandemic

Today, the U.S. Food and Drug Administration (FDA) updated this final guidance: Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.

This updated version clarifies the examples of circumstances—including changes made to microchips or other associated circuitry and/or software changes—where the FDA currently believes a modification would generally not create an undue risk in light of the public health emergency, and that may be needed to address current manufacturing limitations or supply chain issues due to COVID-10 related disruptions.

Read the Guidance

Questions?

If you have questions about this updated final guidance, contact the Division of Industry and Consumer Education.