Labeling; User Guide

[ssaigal]

I am looking for any insight on how the FDA views a QR code that directs user to Company website for current version of User Guide. This is a Class I/ 510k exempt product (FDA & ISO 13485) that is used in a Surgical setting. Also if there is any guidance or information on the FDA/ISO websites that you can direct me to that would be helpful as well.

 

[AngelaLaw]

I would accompany code with website location in event it does not scan. See Item #9 in link below.
I can't post link but look for medical-devices/device-labeling/use-symbols-labeling-frequently-asked-questions#scope1
For your DFU revision document, utilize your website as a distribution location of the approved document revision, when you up rev, then website gets updated accordingly.

Added link @Miner

 

[yodon]

Just to add on a bit... If you do have your User's Guide on your website, recognize that it is considered labeling under regulatory jurisdiction; i.e., it needs to be controlled per your design / document control procedures, just like other controlled documents.

 

[AngelaLaw]

Just to add on a bit... If you do have your User's Guide on your website, recognize that it is considered labeling under regulatory jurisdiction; i.e., it needs to be controlled per your design / document control procedures, just like other controlled documents.

Yes, must be an approved document with revision control, i.e., document controls and additionally the distribution would be to the website location and if maintained by someone other then company, make them an approved supplier.

 

[ssaigal]

Thanks. Yes the plan is to put the IFU under review through our change control process. Then post to the website and QR code. Appreciate all the comments.