Fetal & Maternal Monitoring Guidance

Navigating the Regulatory Pathway during a Global Pandemic

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What are the motivations for the COVID-19 Fetal & Maternal Monitoring guidance?

• • 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?

• • 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??

• • 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?

• • 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?

• • 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?

• • 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?

• • 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?

• • 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?

• • Designing, evaluating, and validating changes made to hardware or software should be done according to FDA recognized standards (Table 3).

 

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