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# Enforcement Guide on PMA/HDE Modifications
- URL: https://www.fdaweb.com/enforcement-guide-on-pma-hde-modifications/
- Published: 2023-11-02T12:00:00.000Z
- Updated: 2026-09-14T14:15:09.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155709

*Federal Register* notice: FDA is making available a final guidance entitled “Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions.” The document outlines FDA’s policies and regulatory review expectations after the Covid–19 public health emergency for certain limited modifications of a device required to have an approved PMA or HDE. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-11-02/pdf/2023-24213.pdf?ref=fdaweb.com).