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How to prepare your medical device company for an US FDA inspection


FDA visits can be challenging, especially when your company isn’t quite up-to-speed in complying with the required regulatory records and reports. Here are some key areas where companies often trip up!


On occasion, regulatory inspectors will announce their visit ahead of time but too often companies take this announcement far too lightly.  This is a mistake especially since the regulations are becoming more stringent and the Regulator, themselves, are more vigilant. These pre-announced visits often come about for Class II and Class III medical devices.


The FDA may also pre-announce a visit because of competitor activity, introduction of a new competitor product, or any common grounds of a regulatory check. Historically, FDA announces their visit schedule. This schedule is not focusing on the reason for the visit but just a basic timeline for you to prepare and keep the documents updated.


The company needs to keep an eye on what’s happening in the marketplace and the industry to monitor what is happening with their competitors and other industry players. The most common reason for an FDA visit is because of medical device reports logged on the FDA’s MAUDE database which records “suspected device-associated deaths, serious injuries and malfunctions”. It is critical that companies continually monitor feedback and reports on their own devices and take appropriate action.


How should you prepare for a FDA inspection?

Here are some tips:

By following these tips, you’ll have a smoother and less stressful time during the US FDA visit. Remember to keep reporting your latest medical device reports to the Regulators.


If you’re in need of 510(k) guidance or any other Medical Device Regulatory assistance, feel free to contact our experts at Med-Di-Dia


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