Keyword Analysis & Research: 510k vs ce

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Frequently Asked Questions

What is the difference between 510 (k) and CE marking?

While 510 (k) is the preferred regulatory strategy of many North American medical device companies, launching in Europe first with a CE mark can be beneficial. This blog concludes my highlights of 510 (k) and CE Marking similarities and differences. Last week I covered Terminology, Device Risk Classification, and Process.

What is the difference between premarket approval and 510 (k)?

The reason 510(k) is the preferred regulatory pathway to reach the US market is clear: Large single market with a transparent regulatory body and minimal costs compared to Premarket approval (PMA). Clients sometimes assume that once the 510(k) is in place it will be trivial to obtain a CE mark and start exporting to Europe.

Do I need to submit a 510 (k) form?

They can be viewed in the device classification database. Generally, if your device is Class II you will need a 510(k) submission– apart from devices which are exempt, or one of the rare class III pre-amendment devices which also require 510(k).

What is a 510 (k) clearance?

The 510(k) is eventually cleared and the client can begin selling products with the sword of Damocles hanging overhead in the form of a pending FDA inspection (of unknown timescale).

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