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

💡 Rob also shares practical advice for manufacturers seeking FDA support during this period, as well as insights into how his team can assist in maintaining compliance and communication continuity.

If you’re part of the medical device ecosystem — this is essential reading.

Tags: FDA, Medical Devices, Regulatory Compliance, Quality Management, US Government Shutdown, Rob Packard, Clinical Trials

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

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