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# Revised Guide on PMA/HDE Supplements During Covid
- URL: https://www.fdaweb.com/revised-guide-on-pma-hde-supplements-during-covid/
- Published: 2022-05-04T12:00:00.000Z
- Updated: 2026-09-14T17:43:12.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151745

FDA has released a revised[ final guidance](https://www.fda.gov/media/138265/download?ref=fdaweb.com) entitled *Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency*. The document outlines the agency’s policy to help address current manufacturing limitations or supply chain issues due to disruptions caused by Covid-19.

The guidance says the agency is continuing for the duration of the public health emergency to not object to limited modifications to the manufacturing of devices approved through the PMA or HDE programs “where the modification does not create an undue risk in light of the public health emergency, and is necessary to address current manufacturing limitations or supply chain issues due to Covid-19-related disruptions.”

The policy also applies to limited modifications that result in changes to the performance or design specifications, circuits, components, ingredients, or physical layout of the device which would trigger the requirement to submit a 180-day or real-time PMA supplement or a 75-day HDE supplement.

Additionally, the guidance provides examples where FDA currently believes a modification would generally not create an undue risk, such as changes made to microchips or other associated circuitry that meet or exceed existing performance specifications and testing plans, and device material changes due to changes in manufacturing methods or supply interruption, among others.