Infusion Pumps & Accessories Guidance

Navigating the Regulatory Pathway during a Global Pandemic

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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?

• • Four Infusion pumps and their accessories. Some infusion pumps have the potential to wireless connect and transmit a patient’s data directly to their health care provider.
  • Eleven infusion pump accessories when use with covered infusion pumps.

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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