The Food and Drug Administration (FDA) issues Emergency Use Authorizations (EUAs) in order to expand the availability of vitally important medical devices during the outbreak of the Coronavirus Disease 2019 (COVID-19). The outbreak of the aforementioned disease, together with its complications and respiratory illnesses associated thereto resulted in a significant increase in demand on certain types of medical devices, including, inter alia, infusion pumps, and infusion pump accessories.
Infusion Pumps: Key points
Infusion pumps are initially intended to provide the patients with the controlled infusion of medicines or any other fluids. The scope of the present EUA also covers medical devices of the aforementioned type equipped with the remote monitoring and/or control features, as well as additional accessories used to maintain the safe distance between patients and healthcare professionals operating the device, that is important during the pandemic on order to reduce the risks associated with the infection.
In general, the application of the Emergency Use Authorization framework is based on the extraordinary and temporary measures to be introduced due to the Public Health Emergency announced earlier in February 2020 as a response to the COVID-19 outbreak. It is important to mention that earlier the FDA already issued the Emergency Use Authorization for SARS-CoV-2 antibody tests.
EUA Application Scope
According to the FDA, the infusion pumps and infusion pump accessories are admissible for the EUA framework providing they are being designed and manufactured in compliance with the appropriate safety, performance, and labeling requirements established by the present Authorization.
The FDA states that its decision to issue the Emergency Use Authorization for infusion pumps and accessories thereto is based on the following:
- The novel coronavirus leads to the outbreak of life-threatening diseases.
- In accordance with the information assessed by the FDA, infusion pumps could be used to treat patients with respiratory illnesses, and the potential benefit associated with the use of such devices exceeds the appropriate risk.
- The infusion pumps covered by the scope of the EUA have no alternative already available on the market among the FDA-approved medical devices.
The FDA emphasizes the importance of additional measures to be taken to address potential shortages in supply caused by COVID-related factors. As it is stated in the justification of the EUA, further spreading of the disease resulted in the interruptions to the normal operations of some of the medical device manufacturers that could potentially lead to shortages in the supply of the vitally important medical devices needed by the patients with respiratory illnesses.
Infusion Pumps EUA Eligibility Criteria
The document issued by the FDA also describes the particular criteria to be applied to determine whether the particular medical device is eligible for the Emergency Use Authorization framework. In particular, the present EUA could be applied to infusion pumps and accessories thereto that are not already FDA-approved, as well as ones that have been approved by the FDA earlier but incurred certain changes requiring additional approval (by submitting the 510(k) premarket notification) before being allowed to be marketed in the US.
The scope of the EUA issued by the FDA covers the following medical devices:
- Infusion Pump (product code FRN),
- Patient-controlled analgesia (PCA) Infusion Pump (product code MEA),
- Infusion Pump Accessories (product code MRZ),
- Infusion Pump Safety Management Software (product code PHC).
All the aforementioned devices could be determined as Class II medical devices under the risk-based classification and are regulated under 21 CFR 880.5725.
The scope of the present Emergency Use Authorization also covers the accessories to the infusion pumps including, inter alia, the following ones:
- I.V. containers and set stopcocks,
- Therapeutic intravascular and midline catheters,
- Administration sets with neuraxial connectors and securement devices,
- Electronic intravascular infusion controllers,
- Infusion stands and other device types.
The accessories covered by the scope of the EUA could be determined as either Class I or Class II medical devices under the risk-based classifications depending on their design, intended purpose, and risks associated with the use of such accessories.
The FDA also provides a list of medical devices failing outside the scope of the authorization. As it is explicitly stated in the EUA, enteral feeding pumps, elastomeric infusion pumps, and insulin pumps could not be placed on the market under the Emergency Use Authorization framework. The scope of the EUA also does not include medical devices intended to be used with the closed-loop systems.
Infusion Pump Authorization Process and Procedures
In order to be allowed to market infusion pumps and accessories associated, medical device manufacturers shall obtain the appropriate confirmation from the regulating authority explicitly stating that the medical device in question meets any and all safety, performance, and labeling requirements. Upon providing such a confirmation, the FDA will also add the device to the list of medical devices authorized under the EUA framework.
To apply for the authorization as described hereabove, the medical device manufacturer shall submit the appropriate request in the electronic form. The request should contain the most important information regarding the infusion pump in question, as well as about its manufacturer, namely:
- Details about the medical device manufacturer, including its name and principal place of business, contact details of the manufacturer itself, and also of its authorized representative in the US (in a case of foreign medical device manufacturer).
- A sample of medical device labeling.
- Information about the marketing approval granted in any other jurisdiction (e.g. certification number).
- Information concerning compliance with the international standards (e.g. ISO 13485: Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes), which should be demonstrated by providing the appropriate documentation.
- Information confirming that the device in question meets any and all eligibility criteria.
Emergency Use Authorization Eligibility Criteria
As stated above, in order to be allowed to be placed on the US market under the EUA framework, the infusion pumps and infusion pump accessories should meet the appropriate eligibility criteria set forth by the FDA.
The FDA makes its decision regarding the eligibility of the medical device in question based on a Declaration of Conformity to be provided by the medical device manufacturer in order to demonstrate that the infusion pump complies with the applicable international IEC and/or ISO standards following criteria and also on the information about:
- The risk management activities,
- The hazards associated with the use of the infusion pump subject to review,
- The hazards associated with the remote monitoring and control systems implemented to the medical device,
- The identified cybersecurity threats and hazards,
- The specifications of the infusion pumps and accessories thereto and the instructions for use accompanying the medical device,
- Reprocessing of the medical device and its shelf life.
In order to be allowed for distribution in the US, the infusion pumps and infusion pump accessories should also meet the appropriate labeling requirements. In particular, the information provided by the medical device manufacturer in the instructions for use should cover the following aspects:
- Specifications of the device,
- Description of the alarms,
- Details about reprocessing of the device and its shelf life,
- Additional instructions that are reasonably necessary.
Summarizing the information provided hereabove, the present Emergency Use Authorization covers infusion pumps and infusion pumps accessories allowed to be marketed in the US under the EUA framework during the pandemic, providing that they meet the appropriate safety, performance and labeling criteria set forth therein.
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