Fetal & Maternal Monitoring Guidance
Navigating the Regulatory Pathway during a Global Pandemic
What are the motivations for the COVID-19 Fetal & Maternal Monitoring guidance?
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- Expand capability of currently marketed non-invasive fetal and maternal monitoring devices.
- Enable remote monitoring outside healthcare facilities to reduce COVID-19 exposure risk.
What medical device types are covered by this guidance?
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- One fetal doppler type (Table 1) that lay users (e.g., patient, caregiver) could be instructed to use in a home setting under the direction of a health care provider via prescription.
- Seven fetal and maternal monitoring device types (Table 2) that could be used by a health care provider via prescription in a home setting.
What Table 1 device changes to indications, functionality, hardware and/or software are permitted??
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- Change indications and instructions if device usage is expanding to include home settings.
- Hardware/software device changes to allow for increased remote monitoring capability; and,
- Mobile device changes facilitating transfer into and out of a vehicle and into a patient’s home.
What Table 1 device modifications are not permitted?
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- The fetal doppler is labeled or modified for use at a lower gestational age than the FDA clearance.
- The fetal doppler is labeled for over-the-counter sale directly to lay users.
- The fetal doppler provides information beyond real time or average fetal heart rate output
- The fetal doppler provides a pulsed output.
What labeling updates does the FDA recommend for modified Table 1 devices?
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- Highlight the differences in design compared to the unmodified, FDA-cleared product along with instructions for mitigating any known risks associated with the modifications.
- Distinctly delineate FDA-cleared indications and claims from those that are not FDA-cleared.
- Provide adequate instructions for lay user in intend (home) environment including gestational age, step-by-step instructions, appropriate warnings, mitigating misinterpretation and troubleshooting.
What Table 2 device changes to indications, functionality, hardware and/or software are permitted?
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- Software/hardware changes to facilitate remote access where the modification does not directly affect the fetal heart rate, maternal heart rate, or uterine activity measurement algorithms.
- Mobile device changes facilitating transfer into and out of a vehicle and into a patient’s home.
What Table 2 device modifications are not permitted?
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- The device is labeled or modified for use at a lower gestational age than the FDA clearance.
- The device is labeled for over-the-counter sale directly to lay users.
- The device is labeled for use by lay users under the direction of a healthcare provider.
- The device applies an algorithm to transform a physiological parameter into a novel index or alarm that may aid a health care professional diagnosis of an obstetric condition.
What labeling updates does the FDA recommend for modified Table 2 devices?
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- Highlight the differences in design compared to the unmodified, FDA-cleared product along with instructions for mitigating any known risks associated with the modifications.
- Distinctly delineate FDA-cleared indications and claims from those that are not FDA-cleared.
- Provide adequate lay instructions if device usage is expanding to include home settings.
- Includes reprocessing instructions for health care providers between multi-patient use.
What is the envisioned validation of COVID-19 changes?
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- Designing, evaluating, and validating changes made to hardware or software should be done according to FDA recognized standards (Table 3).
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