The FDA Maze

The most common request is for assistance with a 510(k) application. Depending on the development stage of the product, materials may or may not be available to put together a successful application. That is why the first step is to perform a gap analysis to determine what what the customer still needs to do before submitting the application. Please check the "FDA 510(k) Submissions" page to see what is involved.

Premarket clearance starts long before the 510(k) documents are written. Ideally, you should know what the FDA will require as soon as you have a prototype of your device. The reason? Testing for efficacy and safety has to conform to FDA requirements. Otherwise, time will be lost generating the data you need to get market approval; time that could have been spent selling your product and generating revenues.

Once the decision is made to go ahead with the application, we work closely with you in preparing the application. This is because Indications for Use, labeling, manuals etc. must be synchronized with the information presented in the 510(k) application. Contrary to widespread belief, non-US entities are permitted to submit 510(k) applications and are not obligated to submit applications through the US Agent.

As far as the FDA is concerned, "The responsibilities of the U.S. agent are limited and include:

In practice, the duties of a US Agent usually have a much wider scope because this is how the customer wants it. You, the customer are in control over how much or how little we do for you.

The second most common request is for help with detained entry of a device. The FDA is becoming more vigilant and at the same time is understaffed, with the result that an FDA Agent can put an indefinite hold on any device entering the US with no justifcation and pending investigation. While this can be frustrating, there is plenty that can and should be done in advance to avoid this situation. If you are dealing with a detained entry of your product for no cause AND your establishment listing and device registration are in order, the FDA will most likely release the shipment after a week or two. If a specific reason for the Hold is given that you do not agree with, it is the US Agent's job to get the shipment moving again by communicating with the FDA Agent.

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November, 2021. All rights reserved.