The Food and Drug Administration (FDA) published draft guidance on the content of premarket submissions for device software functions on November 4, 2021. The guidance is not binding, but represents the FDA's recommendations for what developers should include, so that the FDA can evaluate the safety and effectiveness of device software functions. The FDA will host a webinar to discuss the draft on December 16, 2021 at 1:00 ET. Comments should be submitted on the draft guidance by February 2, 2022. When the guidance is final, it will supersede existing guidance published in May 2005.

The guidance applies both to a device software function that controls or is part of a hardware device (Software in a Medical Device, or SiMD), and software that is used for a medical purpose without being part of a hardware device (Software as a Medical Device, or SaMD). The FDA suggests that basic documentation can be provided for certain premarket submissions, while enhanced documentation will be required when any of the following factors apply:

  • The device is part of a combination product
  • The device is intended to test blood donations or determine blood donor and recipient compatibility
  • The device is a Class III device (higher risk devices that provide life-supporting or life-sustaining functions, or that present potential serious risk of illness or injury)
  • A failure or latent flaw of the device software function could present a probable risk of death or serious injury to a patient, user or others in the environment of use, as assessed prior to implementing risk control measures.

The guidance includes an outline of documentation to be included, examples illustrating which devices would require basic or enhanced documentation, and example architecture design charts.

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