Regulatory Notification for IVD IFU Instructions Revision

[orangeisenergy]

Hi all,
We are updating an instructions for use pamphlet that goes out with one of our IVD tests. The revision is in response to published findings on acceptable sample collection methods- there are more than the 1 currently defined sample collection apparatus' that will work for our test, so we are adding those to our instructions for use. We will be notifying all customers of the update. My question is: does this change require regulatory notification?

 

[scda0505]

Depending on the sample collection method, I would think as long as the sample type remains the same, you would not require regulatory notification.

 

[orangeisenergy]

Thanks for the input! Yes, the sample type is the same. It just specifies different types of swabs that are acceptable to collect the sample.

I read 21 CRF 809.10 for IVD labeling requirements, but it didn't specify what changes require regulatory notification. Could anyone point me in the direction of where I can find what changes require regulatory notification?

 

[ManTheDan88]

Here's a link to the FDA guidance on Deciding When to Submit a 510(k) for a Change to an Existing Device:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm#page9

Flowchart D is for IVD devices.

I would say a letter to the file (documentation) with the appropriate testing done to validate the new swabs with the specimen would be sufficient.