June 1, 2020
On April 23, 2020, The U.S. 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. 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.
FDA'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:
- Fetal ultrasonic monitor (i.e., fetal doppler).
- Fetal cardiac monitor.
- Fetal phonocardiographic monitor.
- Ultrasonic fetal heart rate monitor.
- External (for use in clinic) uterine contraction monitor.
- Uterine electromyographic monitor.
- Perinatal monitoring system.
- Obstetric ultrasonic transducer.
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. All remaining devices are intended for use by a health care provider in a home setting, with a prescription.
For 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. 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.
The guidance does not aim to make such devices available to patients over the counter (OTC). 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. A key element to allowing clinical devices to be used at home is proper labeling modification. New labeling must reduce risk by including information that allows a lay user to safely operate the device. 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.
Verification and validation requirements for device modifications remain the same. 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. FDA recommends that all modifications to hardware or software be performed in accordance with FDA-recognized standards, such as ANSI 60601-1, ANSI 60601-1-2, IEC 60601-1-11, and ANSI 62304. In addition to conducting the recommended testing, manufacturers are also required to document changes to the devices per design controls (21 CFR 820.30) and general requirements (21 CFR 820.180).
Examples of modifications manufacturers may make include:
- Change to instructions for use (IFU) or device display to facilitate use at home by a lay person (in the case of the fetal doppler).
- Change to hardware or software to allow for increase remote monitoring capability.
- Modifications to make the devices more mobile and easier to transport to a patient's home.
Allowing the use of monitoring devices at home can have implications on pregnancy management. Manufacturers of these monitoring systems must evaluate the proposed modifications to their devices to minimize potential risk to the patient.
A recent study on the use of wearable at-home health monitoring devices during pregnancy highlights the importance of clear indications for use, interpretations of the data presented by the device, and reliability of the data especially if generated by a lay user. It also highlights the importance of facilitating effective communication and data transfer between patients and providers.
How Exponent Can Help
Exponent's team of biomedical engineering consultants supports clients with technical, regulatory, safety assessment, epidemiological, and health economics issues involving diagnostics and wearables. We can assist with modification verification and validation testing, user study design and management, labelling modification, and documentation of modifications per regulatory guidelines.