FDA relaxes infusion pumps and thermometers guidelines
The Food and Drug Administration (FDA) has released relaxed guidelines for infusion pumps and clinical thermometers due to the COVID-19 pandemic.
The relaxed guidance hopes to increase the availability of these devices which are currently in high demand, and adds to other guidelines recently released by the organisation for medical devices such as ventilators.
The document states that the FDA’s enforcement policy for infusion pumps applies to devices under four different product codes, and more than 20 different types of accessories that are used with infusion pumps.
The FDA says: “Wherever possible, healthcare facilities should use FDA-cleared infusion pumps and accessories to provide infusion therapy, or a device authorised by an Emergency Use Authorisation (EUA).” However, the organisation acknowledges that: “Such devices may not always be available, and to help ensure the availability of the greatest possible number of devices for this purpose, as described in more detail below, FDA does not intend to object to limited modifications to the indications, functionality, hardware, software, design, or materials of FDA-cleared devices used to support patients who require continuous infusion therapy, without prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81,12 for the duration of the public health emergency.”
Under the policy, FDA explains that it will not object to companies making these modifications to already cleared infusion pumps or accessories, so long as the modifications would not “create an undue risk.” The FDA lists examples of these within the document.
Additionally, the FDA will also allow infusion pump accessories to be used outside their indicated shelf life and duration of use due to the need for these devices during the Coronavirus pandemic.
Emergency Use Authorisations (EUAs) will be granted by the FDA for infusion pumps that are not currently legally marketed in the US, and to non-medical device manufacturers who may be able to assist in increasing the supply of the devices.
The new guidelines only apply to certain thermometers: “The enforcement policy in this guidance applies to clinical electronic thermometers, which are regulated as class II devices under 21 CFR 880.2910, product code FLL.”
In an attempt to ensure supply is able to meet demand, the document also states that the: “FDA does not intend to object to the distribution and use of clinical electronic thermometers that are not currently 510(k) cleared without compliance with the following regulatory requirements where such devices do not create an undue risk in light of the public health emergency.”
The documents can be viewed in full using the links below:
Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019
Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019