Class 2 - 510(k) exempt

Haley0206

Registered
Hi All,

Our device falls under Class 2 - 510(k) exempt (Oscillometer).
Usually for 510(k) submissions, we will be providing all the required documents using the eSTAR template. Similarly, I would like to know whether there is a specific list of documents required for 510(k) exempt Class 2 devices to be submitted to the FDA.
 

EmiliaBedelia

Quite Involved in Discussions
If the device is 510k exempt, you don't have to submit anything to the FDA. You still need to follow design controls and follow the QSR requirements as well.

Personally I always document the regulatory determination for a Class I or otherwise exempt device in a "Letter to File" as evidence to justify why a 510k was not required. So, I would suggest to do that and document the design control activities that were completed to support the device
 
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