Premarket Submissions of Device Software Functions

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Premarket Submissions of Device Software Functions

Authors: Helen Simons

How the FDA’s new guidance on software documentation changes current requirements

On November 4th, 2021, the FDA issued a new draft guidance: Content of Premarket Submissions for Device Software Functions. This draft guidance was issued for commenting and is intended to replace their previous guidance on the subject, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices from May 2005.

Over 15 years old, the original guidance is well used and understood by industry. So the changes in this new version will require significant changes in mindset about how to carry out and document software development. Whilst draft guidances are intended to be drafts for comment, there is an understanding that they are the latest thinking from the FDA and should be considered when developing medical devices. In a recent Q&A session, the FDA were keen to emphasize that the draft guidance is not in affect yet. They did not elaborate on when it might be finalised, however, they did say that the commenting period is open until February and they expected it to be “some time” before the draft would be final.

This draft guidance document is intended to provide information regarding recommended documentation that should be included in premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions. It applies to the following types of submissions:

  • Premarket Notification (510(k))
  • De Novo Classification Request
  • Premarket Approval Application (PMA)
  • Investigational Device Exemption (IDE)
  • Humanitarian Device Exemption (HDE)
  • Biologics License Application (BLA)

This list has been expanded to reflect the submission types that are now available compared to those in 2005. Additional documentation may also be required for post-market activities relating to software. This guidance specifically looks at premarket submissions for Device Software Functions.

The guidance also clarifies that it applies to both Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD), but it does not apply to automated manufacturing and Quality System software or software that is not a device. This is a helpful delineation of scope covering Device Software Functions Premarket Submissions.

How the FDA’s new guidance on software documentation changes current requirements

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