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# Enforcement Discretion on Infusion Pump Modifications
- URL: https://www.fdaweb.com/enforcement-discretion-on-infusion-pump-modifications/
- Published: 2020-04-06T12:00:00.000Z
- Updated: 2026-09-14T16:10:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146501

FDA has posted a [final guidance](https://www.fda.gov/media/136701/download?ref=fdaweb.com) entitled “Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency.” The policy applies to large volume parenteral infusion pumps, syringe infusion pumps, patient-controlled analgesia infusion pumps, and ambulatory infusion pump devices, and their accessories, in order to support patients who require sustained infusion therapy during the Covid-19 public health emergency. Recognizing that such devices may not always be available, the guidance says that the agency does not intend to object to limited modifications to the indications, functionality, hardware, software, design, or materials of FDA-cleared devices used to support patients who require continuous infusion therapy, without prior submission of a premarket notification (510(k)).

The policy applies where a modification is made to the device that triggers the requirement that a manufacturer submit a new 510(k), FDA says. It provides examples of such changes, such as a change or modification in design, intended use, material, chemical composition, energy source, or manufacturing process. More specifically, the policy-covered examples include:

- Changes to the infusion pump motor to allow an alternate supplier to meet the required design specifications, or
- Enabling an alternate supplier of infusion pump accessories to meet the established performance of the FDA-cleared device.