How Will the FDA Regulate Medical Device Software?

The FDA wants to be crystal clear about how it will regulate medical device software that help doctors make decisions about patient care. Device software functions may include “Software as a Medical Device (SaMD)” and “Software in a Medical Device (SiMD).”

The 21st Century Cures Act removed certain software functions from the definition of a medical device. But the Act gave the FDA the power to decide the definition.

There was uncertainty by makers of device software, so the FDA issued new guidelines on September 26, 2019 to clarify where the agency intends to focus its oversight over software and products that use artificial intelligence to guide treatment of serious or critical conditions.

The agency said it was issuing the guidance “to clarify the subset of software functions to which the FDA intends to apply its authority.”

The guideline states the FDA intends to apply its regulatory authorities “to select software applications intended for use on mobile platforms (mobile applications or “mobile apps”) or on general-purpose computing platforms.”

The agency added it intends to apply its regulatory oversight to only those software functions that are medical devices and whose functionality could pose a risk to a patient’s safety if the device were to not function as intended.

The 45-page guidance document offers the example of a clinical decision support (CDS) tool that identifies hospitalized, type 1 diabetic patients at increased risk of postoperative cardiovascular events and which does not explain why the software made that identification to the health care professional.

The “nonbinding recommendations” guidance is titled “Policy for Device Software Functions and Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff.”