U.S. Food and Drug Administration (FDA) issued this immediately in effect guidance: Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID- 19) Public Health Emergency. FDA believes the policy set forth in this guidance may help address these urgent public health concerns by helping to expand the availability and remote capabilities of infusion pumps and their accessories during COVID-19 for patients requiring continuous infusion therapy.
SoftwareCPR Comments on FDA Emergency Guidance for Infusion Pumps
This emergency use infusion pump guidance temporarily exempts a wide range of changes to infusion pump hardware and software from premarket review. It applies to four Class II product codes (FRN, MEA, MRZ, and PHC), and three of which likely could involve software. The guidance also addresses 22 product codes for accessories to infusion pumps.
Specific areas where FDA believes modifications present low risk include:
- Software and/or design modifications implementing the capability for remote monitoring and remote manual adjustment of infusion parameters (i.e., manual adjustment of parameters by trained health care providers from outside an isolation unit to avoid unnecessary exposure). These modifications might include implementing the capability for remote monitoring and remote manual adjustment of infusion parameters via wired or wireless methods.
- Modifications to the software to implement remote monitoring and adjustment of infusion parameters for multiple infusion pumps in a central location. This includes new hardware or software accessories for remote monitoring and remote manual adjustment of infusion parameters.
- Modifications or additions to the hardware/software architectures to allow for increased remote monitoring and manual setting adjustment capability and availability to support additional indications described above. One example is the addition of wireless and/or Bluetooth capability.
- Additional hardware, software, design and material changes to an FDA-cleared infusion pump system accessory or component (e.g., material change to internal tubing) that enables an alternate accessory or component supplier to meet the established performance of the FDA-cleared system.
Note that cybersecurity controls are still expected.
Obviously manufacturers should still ensure adequate (for the current public health emergency) validation to ensure safety for critical changes. While FDA has suspended all routine inspections, we also recommend that manufacturers that use this emergency exemption to later plan for actions to deal with an eventual return to normalcy in clearance requirements and return to use within normal intended use.
Download the guidance here: Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff April 2020