On November 3, 2021 the FDA issued draft guidance titled “Content of Premarket Submissions for Device Software Functions.” The final version will eventually replace the FDA’s “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” originally released in May 2005.

In a press release Bakul Patel, director of the FDA’s Digital Health center, stated:

 “As technology continues to advance all facets of health care, software has become an important part of many products and is integrated widely into medical devices. The FDA recognizes this evolving landscape and seeks to provide our latest thinking on regulatory considerations for device software functions that is aligned with current standards and best practices.”

The draft guidance pertains to software in a medical device (“SiMD”) and software as a medical device (“SaMD”). The Regulatory Affairs Professional Society (RAPS) describes SiMD as “software that is a part of a medical device or controls it” and SaMD as “software that meets the definition of a device but is not part of the overall device’s hardware.” According to the FDA, both SiMD and SaMD are “device software functions.”

The draft guidance is intended to cover: firmware and other means for software-based control of medical devices, stand-alone software applications, software intended to be operated on general-purpose computing platforms, dedicated hardware/software medical devices, and accessories to medical devices when those accessories contain or are composed of the software.

Portions of the draft guidance to consider include the software device documentation and software risk management requirements. Software may require a basic or enhanced level of documentation, depending on risk to a patient, user, other individual, or environment.  A risk assessment and risk management plan may be required.

The draft guidance can be found here.