Lexology January 22, 2025
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
FDAs’...
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