Rules are Changing

Rules Are Changing for FDA Submissions for Software

Big news! After 16 years, the FDA is changing its guidance on the software documentation needed in regulatory submissions. Last month, the new draft guidance, “Content of Premarket Submissions for Device Software Functions,” was announced. When finalized, this new guidance will supersede the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005).

This new draft guidance is quite different from the 2005 guidance. Here are some key changes in it:

  • The documentation will no longer be determined by software Level of Concern (Minor / Moderate / Major); instead, it will be determined as needing Basic or Enhanced level of documentation (based on the software’s risk).  The Enhanced level is required if any of the following apply:
    • Class III or combination device
    • Device tests blood donations or determines donor-recipient blood compatibility.
    • Device software functions could present a probable risk of death or serious injury (pre-mitigations).
  • The Device Hazard Analysis is replaced by the device’s Risk Management File documents.
  • The new guidance allows for the declaration of conformity to the IEC 62304 medical software standard.
  • The new guidance has more explanations of what is required in each type of software document, such as the architecture diagram.

For more information on the changes, I recommend this summary by John Murray of SoftwareCPR:   New FDA draft Software Premarket Submission Guidance

Nov 3, 2021 Announcement

Guidance Document


Image source:

Leave a Comment

Your email address will not be published. Required fields are marked *