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# Covid PMA or HDE Supplement Guidance
- URL: https://www.fdaweb.com/covid-pma-or-hde-supplement-guidance/
- Published: 2020-05-21T12:00:00.000Z
- Updated: 2026-09-14T16:15:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146843

FDA has issued an immediately-in-effect guidance, *Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency*, to provide a policy to help address current manufacturing limitations or supply chain issues due to disruptions caused by the Covid-19 public health emergency. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/supplements-approved-premarket-approval-pma-or-humanitarian-device-exemption-hde-submissions-during?ref=fdaweb.com) applies to limited modifications affecting the safety or effectiveness of a device approved through the PMA programs that would trigger the requirement that a manufacturer submit a PMA supplement or 30-day notice to FDA under the regulations.

The policy also applies to limited modifications affecting the safety or probable benefit of a device approved through the HDE program that would trigger the requirement that a manufacturer submit an HDE supplement or 30-day notice to FDA.

The guidance says examples of such modifications may include, but not be limited to: 

- design and manufacturing changes to address component unavailability due to supply chain disruptions;
- manufacturing changes to allow the establishment to maintain operations and accommodate social distancing practices;
- changes in manufacturing facility or establishment; and
- changes to packaging procedures.

The policy does not apply to design or manufacturing changes made for reasons other than addressing manufacturing limitations or supply chain issues resulting from the Covid-19 emergency or any proposed changes described in a regulatory submission already received by FDA.