Lexology January 22, 2025
Reed Smith LLP

FDA is pushing out new guidance documents at a pace rarely seen, likely caused by the upcoming change in administration. Today, we are sharing with you our thoughts on two of FDA’s guidance documents, but we have a few more coming. We’ll need to keep an eye on whether the Trump administration retains or makes changes to any of these last-minute guidance documents.

The two guidance documents we will discuss today are:

  • Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products; and
  • Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations

We briefly summarize below the key takeaways for each guidance document.

Scientific Information on Unapproved/Uncleared Uses

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Topics: AI (Artificial Intelligence), FDA, Govt Agencies, Technology
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