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Description:
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US Government Shutdown – What the FDA Can Still Be Doing?
When the U.S. government experiences a shutdown, the consequences ripple across every industry — but for medical device manufacturers, the uncertainty can be alarming. In this article, Regulatory Expert Rob Packard explores what happens to the U.S. Food and Drug Administration (FDA) during a shutdown, and how it affects global manufacturers.
You’ll learn:
- Which FDA activities continue, and which are suspended
- How submissions like 510(k), PMA, and De Novo are impacted
- What happens to clinical trials, recalls, and ongoing investigations
- Whether this situation has happened before and how long it could last
- How companies can prepare and what contingency actions to take
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