FDA recommends that all modifications to hardware or software be performed in accordance with FDA-recognized standards, such as ANSI 60601-1, ANSI 6, IEC 6, and ANSI 62304. Per 21 CFR 820.30 (f) and (g), design outputs must meet design inputs, and the modified devices must conform to defined user needs and intended uses. Verification and validation requirements for device modifications remain the same. In its guidance, FDA provides clear expectations of what should be included in the labeling so that users can understand the impact of device modifications. New labeling must reduce risk by including information that allows a lay user to safely operate the device. A key element to allowing clinical devices to be used at home is proper labeling modification. On the contrary, FDA clearly states that use of fetal/maternal monitoring devices shall only be permitted with a prescription and that it will object to labelling changes intended to allow OTC sale. The guidance does not aim to make such devices available to patients over the counter (OTC). Manufacturers may make these modifications without submitting a new 510(k) as long as the modifications do not create unnecessary risk and manufacturers comply with performance and labeling requirements. All remaining devices are intended for use by a health care provider in a home setting, with a prescription.įor the duration of the COVID-19 Public Health Emergency, FDA will not object to limited modifications to indications, functionality, hardware, or software of previously cleared fetal/maternal monitoring devices. The fetal doppler is suggested for use by lay users in a home setting, with a prescription and under direction of a health care provider. External (for use in clinic) uterine contraction monitor.Fetal ultrasonic monitor (i.e., fetal doppler).FDA's GuidanceįDA's Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency is applicable to the following Class II medical devices classified as fetal dopplers and fetal and maternal monitoring devices: The enforcement policy outlined in the guidance, which goes into effect immediately, allows for modified use of devices previously only employed in a clinical setting to facilitate patient monitoring at home and increase access to important prenatal data while also reducing patient-provider contact during the COVID-19 pandemic. Food and Drug Administration (FDA) issued guidance to expand the availability and capability of non-invasive fetal and maternal monitoring devices designed to measure or detect fetal heart rate, maternal heart rate, or uterine activity.
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