The US Food and Drug Administration (US FDA) has proposed to amend the medical devices Quality System Regulations (QSR) under 21 CFR 820. The current QSR regulations date to 1978 and have been amended only once in 1996. This action, if implemented, will align 21 CFR 820 more closely with ISO 13485:2016, the international consensus standard for devices widely accepted by global Regulatory Authorities. The FDA believes that globally harmonizing the device regulation will help provide consistent, safe, and effective devices, contributing to public health through timely access for patients.

With the evolution of technology, the healthcare industry has become keen on integrating software with medical devices to incorporate automation and accuracy in the prediction, diagnosis, prevention, treatment, and management of health conditions. The US FDA had long recognized the role software can play to benefit the functioning of medical devices but was yet to come up with any concrete guidance or rules that could have facilitated the industry researchers in making advancements towards digital health.