FDA Relaxes Rules for Infusion Pumps, Clinical Thermometers
Adding to a growing list of medical devices with eased regulatory requirements amid the coronavirus disease (COVID-19) pandemic, the US Food and Drug Administration (FDA) over the weekend released new guidances for infusion pumps and clinical thermometers in an effort to increase availability of the devices.
The two guidelines, which take effect immediately, follow similar guidelines released in recent weeks covering diagnostic tests, ventilators, surgical apparel, face masks and respirators.
FDA says its 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.
FDA stresses that health care facilities should continue to rely on FDA-cleared infusion pumps and accessories when possible but acknowledges that may not be possible due to heightened demand for the devices due to COVID-19.
Under the policy, FDA explains that it will not object to companies making certain modifications to already cleared infusion pumps or accessories, so long as the modifications would not “create an undue risk.”
The allowable modifications include adding remote monitoring, control and electronic drug library information transfer functionality; allowing use in new environments and patient populations; battery capacity increases; and modifications to increase the devices’ wireless range.
FDA will also allow for use of infusion pump accessories outside their indicated shelf life and duration of use.
The guidance provides a list of 20 FDA-recognized consensus standards that FDA says should be used in the design, evaluation and validation of modifications made under the policy.
In addition to easing requirements for modifications, FDA says it is interested in granting emergency use authorizations (EUAs) 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.
To increase the availability of clinical electronic thermometers, FDA says it will not object to the distribution or use of certain non-510(k) cleared devices.
FDA notes that the policy only applies to certain contact and contactless Class II clinical thermometers under product code FLL and directs companies with already cleared clinical electric thermometers to its enforcement policy on modifications to those and other remote patient monitoring devices.
FDA says the devices must be manufactured in accordance with 21 CFR Part 820, ISO 13485:2016 or an equivalent quality system. The devices must also be authorized in the EU, Australia, Canada or Japan or meet certain performance standards laid out in the guidance and include labeling that details the devices’ indications and functions.