The differences between the different kinds of FDA clearance

Companies that want to sell a medical device in the US have to register with the Food and Drug Administration (FDA) and notify their intention at least 90 days before they attempt any supplies or sales. There are different pathways you can follow, so let’s look at the options.

The differences between the different kinds of FDA clearance

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510(k) Premarket Notification

This is a requirement of the Food, Drug and Cosmetic Act, and as it’s listed in section 510(k) of the legislation. It’s known as an FDA 510k clearance process, although strictly speaking, its correct title is a Premarket Notification.

The FDA will look at the information provided and decide whether the new device is the same as one that is already classified. Every month, the FDA updates its list of items that are “substantially equivalent” to items that have already been approved.

A third-party reviewer can improve your chances of success

However, you don’t have to go through the FDA personally to get your device cleared. There is also the “third party review” list. This is a catalogue of those devices that the FDA allows third parties to review. The third party has to be approved under their Accredited Persons Program

Using a competent third-party reviewer to act for you can make a huge difference in how quickly you get your product to the market, shaving off nearly 100 days in some cases. In addition, a professional third-party review will assess whether your product is eligible for FDA clearance, saving you a great deal of wasted effort and money if it is not.

In the initial phase, the review company will ensure that everything you need for your FDA submission is present and correct, eliminating the frustration of having your application returned because a piece of documentation is incorrect or missing. They’ll also complete the FDA initial checklist.

You’ll then move into the substantive review phase, during which your assigned reviewers will want to ask you for more information and clarify any points that are unclear. A scientific assessment will be performed, the results will be documented, and the recommendation will be finalized.

Finally, the review company will submit your application to the FDA and track it. The FDA has 30 days to respond, and hopefully you will then be one step closer to taking your product to the American market.

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