On April 5, 2020, the U.S. Food and Drug Administration (FDA) issued guidance about its “Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” The enforcement policy is intended to help expand the availability and remote capabilities of infusion pumps and their accessories for patients requiring continuous infusion therapy. The policy is effective only for the duration of the COVID-19 public health emergency.
FDA does not intend to object to limited modifications to the indications, functionality, hardware, software, design or materials of certain FDA-cleared infusion pumps where the devices are used to support patients who require continuous infusion therapy, without prior submission of a 510(k), where the modification will not create an undue risk in light of the public health emergency. The enforcement policy applies to infusion pumps, as classified in 21 CFR 880.5725, in four listed product codes (FRN, MEA, MRZ, PHC), and becomes relevant where a modification is made that would typically require a manufacturer to submit a new 510(k) to FDA. The guidance also lists accessories associated with the infusion pumps in the identified product codes.
The policy is particularly targeted at device manufacturers, allowing more flexibility to make modifications that address manufacturing limitations or supply shortages related to the public health emergency. One example that FDA provides is changes to the infusion pump motor to allow an alternate supplier to meet the required design specifications.
For modifications to FDA-cleared indications or functionality and FDA-cleared hardware, software, design or materials of these devices, FDA provides examples where it currently believes a modification would or would not create such undue risk. With respect to remote capabilities of infusion pumps, FDA also does not intend to object to modifications or adding to the device hardware/software architectures to allow for increased remote monitoring and setting adjustment capability/availability to support the types of additional indications that FDA provides in its examples. FDA also cautions that manufacturers should develop and implement appropriate cybersecurity controls to assure device cybersecurity and maintain device functionality and safety.
For infusion pump system accessory devices labeled with specific durations of use and shelf life, FDA does not intend to object to the distribution and use of infusion pump accessories beyond their indicated shelf life and/or duration of use where this does not create an undue risk in light of the public health emergency. Part of FDA’s non-objection applies when devices do not comply with regulatory requirements for prior submission of a 510(k), Registration and Listing requirements, Quality System Regulation requirements, reports of corrections and removals, and Unique Device Identification requirements. FDA provides examples of circumstances where it currently believes a change would or would not create such an undue risk.
Manufacturers who design and make modifications as described above are still expected to evaluate and validate changes to hardware, software, design, materials or duration of use. FDA recommends that manufacturers consider a list of guidance documents and FDA-recognized standards when designing, evaluating and validating the modifications, as applicable. FDA also refers to performance testing and recommends that manufacturers address a list of examples of hazardous situations through risk control measures or mitigation strategies and verification and validation to avoid creating an undue risk. Additionally, manufacturers must document changes to their device in their device master record and change control records and make this information available to FDA, if requested.
With respect to labeling of the modified devices, FDA recommends using labeling that helps users better understand the device modifications, including a clear description of the device’s new indications or functions, and information on the device’s performance and potential risks; and adequate instructions for use for the intended user and indicated environment of use. Labeling also should highlight design differences compared to the unmodified, FDA-cleared version of the device, along with instructions for mitigating any known risks associated with these differences. Another recommendation to help users better understand the device modifications is to clearly delineate FDA-cleared indications from those that are not FDA cleared. FDA also recommends the labeling include a general statement about changes that have not been cleared by FDA.
FDA states that it is interested in interacting with manufacturers of infusion devices that are not currently legally marketed in the U.S. as well as manufacturers who have not previously been engaged in medical device manufacturing with capabilities to increase supply of these devices.
As with other recent Enforcement Policy guidance documents, FDA intends to work interactively with such manufacturers through its EUA process. Interested manufacturers should send FDA information specified in the guidance to CDRH-COVID19-InfusionPumps@fda.hhs.gov. Where appropriate under the circumstances, FDA will notify the manufacturer that it does not intend to object to the distribution and use of the device while the manufacturer is preparing, and FDA is reviewing, the EUA request.
As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.