ARTICLE SUMMARY:
FDA recently revised its guidance allowing more digital health and noninvasive remote monitoring devices to be modified without pre-market review during the COVID-19 pandemic. Device regulatory expert Allison Komiyama offers valuable advice for companies in this paradigm-shifting space that are working with FDA.
The COVID-19 pandemic continues to take a global toll, costing lives and bringing upheaval to societies and economies. Digital health and remote patient monitoring technologies have emerged as critical tools for mitigating disease spread, preserving personal protective equipment, and collecting and analyzing patient health data rapidly and easily, among other benefits. Recognizing the critical role that these technologies play, on June 5, FDA issued expanded guidance on the use of noninvasive remote monitoring devices for patient care during the COVID-19 public health emergency. The goal of the revised guidance, originally issued in March, is to foster the continued availability of safe and effective medical devices while being flexible regarding modifications made to these devices in response to COVID-19. This important guidance allows modifications that “may increase access to important patient physiological data without the need for in-clinic visits,” as well as facilitating both in- and outpatient management, without FDA premarket review. “Home-based monitoring for COVID-19 symptom escalation has been particularly valuable to help ease burdens on hospitals and other healthcare facilities and reduce the risk of exposure for patients and healthcare providers,” says FDA in the new documentation.
