Infusion Pumps & Accessories Guidance
Navigating the Regulatory Pathway during a Global Pandemic
What are the motivations for the COVID-19 Infusion Pumps and Accessories guidance?
- COVID-19 patients may require continuous infusion of medications, nutrition, and/or other fluids.
- It is necessary to increase access to an adequate supply of devices to treat these patients.
- New technologies help protect providers by maintaining the physical distance from the patient.
What medical device types are covered by the guidance?
What type of modifications to indications or functionality are permitted?
- Remote infusion pump monitoring/control without provider entering patient’s room.
- Wireless transfer of electronic drug library information.
- Infusion pump use for ground/air transport not indicated in original labeling.
- Infusion pump use for patient populations not explicitly reference in original labeling.
What type of modifications to indications or functionality are not permitted?
- Change labeling for device’s use in a magnetic resonance (MR) environment;
- Implementation of physiological closed loop control systems.
What type of hardware, software and materials changes are permitted?
- Hardware/software changes for remote/centralized infusion parameter monitoring/adjustment.
- Changes to increase battery capacity of the device.
- Increase distance between patient and provider through administration set changes.
- Hardware/software/material changes accommodating alternate accessory/component supplier.
What permitted changes around shelf life and duration of use?
- The devices are used according to healthcare institutional protocols.
- The device is not distributed or used if there is evidence of malfunction or visible soiling.
What is envisioned validation of COVID-19 changes?
- Designing, evaluating, and validating changes made to hardware, software, materials or duration of use should be done according to FDA recognized standards.
What COVID-19 labeling updates does the FDA recommend for modified devices?
- Describe device, performance and potential risks for new indications or functions.
- Provide adequate instructions for use by intended user in indicated environment(s), including mitigation of any known risks associated with differences from FDA-cleared operation.
- Distinctly delineate FDA-cleared indications and claims from those that are not FDA-cleared.
What needs to be submitted for Emergency Use Authorization of international devices?
- Manufacturer contact information and copy of the product labeling.
- Whether the device currently has marketing authorization in another regulatory jurisdiction.
- A summary of performance data available for long term use of the device.
- Whether the device is designed, evaluated, and validated by FDA recognized standards.
- Whether the device is designed with a U.S. compatible power supply.
- Whether device manufacture complies with FDA Medical Devices Quality Management Systems.
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