Labeling; User Guide

S

ssaigal

Registered
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.
 
A

AngelaLaw

Registered
Last edited by a moderator:
Y

yodon

Leader
Super Moderator
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.
 
A

AngelaLaw

Registered
yodon said:
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.
Click to expand...
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.
 
S

ssaigal

Registered
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.
 
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