Don’t expect too much action on device-specific issues from the US Congress in coming months, a panel of experts said at the Food and Drug Law Institute’s annual conference in Washington, DC, last week.
The four panelists -- who included a Senate aide, an FDA official, and two lobbyists -- agreed that right now, Congress wants to see results from the user fee packages, included in last December’s omnibus spending bill, before it passes other laws related to the US Food and Drug Administration. Major device-related provisions of that legislative package included cybersecurity measures, pandemic preparation, and predetermined device change control plans
Key Takeaways
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Congress wants to see the outcomes of recent legislation before it moves on most additional FDA reform.
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The FDA is asking for additional authority to better monitor device shortages in the re-authorization of PAHPA, but Congressional staff expect the idea to face some skepticism.
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