FDA, Classification Rules & Medical Software Devices

Hello

first of all Happy new year!

I will start to work for a small company which produces a device used to allow medical devices connectivity and they want to have an FDA clearance for the device.

I would like to understand a little more about FDA medical devices classification and also about FDA position regarding medical devices software and the needed software validation. I’ve looked in the FDA website but I cannot understand how classification is done and which documents should be prepared to ask for an FDA clearance for a device.

I would appreciated some input on this matter. I know the process in europe for CE marking and the standards to follow. But not how this process is done in USA.

Thank you!

Emilia

1. Find a predicate device...something that does the same thing, or kind of the same thing. Determine from FDA records or manufacturer inquiry, what FDA Product Code (three letters, there are several thousand) and Class (I, II or III) apply to it. Your device may have the same classification.

Your goal is to achieve the lowest possible classification. Cost to market for a Class III device will be several hundred thousand dollars. Cost to market for a Class II device may be five to ten thousand dollars. Cost to market for a Class I device is minimal.

2. If your device presents substantial potential risks, or risks that may not be fully understood or are always present even though arguably outweighed by potential benefits, it may be Class III. If the risks are lesser and are well controlled, it may be Class II.

3. If a device is a wholly new concept--nothing like it has been marketed before in the US--you'll have to ask the FDA how to classify it. You'll prepare a description, which amounts to an argument for the lowest classification you think you can justify.

MIREGMGR said:

<snip>... Cost to market for a Class II device may be five to ten thousand dollars...<snip>

Click to expand...

Clarification - cost to the market may include Clinical Trials that may require a much greater investment even for Class II devices.

I now understand how FDA works