Melissa A Basnight - Comment

Document ID: FDA-2013-N-0125-0003
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: April 19 2013, at 12:00 AM Eastern Daylight Time
Date Posted: May 21 2013, at 12:00 AM Eastern Standard Time
Comment Start Date: April 19 2013, at 12:00 AM Eastern Standard Time
Comment Due Date: June 18 2013, at 11:59 PM Eastern Standard Time
Tracking Number: 1jx-84v7-l1gw
View Document:

This is comment on Proposed Rule

Use of Certain Symbols in Labeling

View Comment

The FDA guidance entitled "Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use" should be used allowed across all devices instead of just IVD's. There is an ISO standard BS EN 980 that lists all universal symbols for the European committee and the FDA guidance already mimics this standard. Since most companies sell in the US and the EU it would be beneficial to have the same standards used for all medical devices. Especially with the new regulation of adding a UDI for all medical devices and labeling real estate can get challenging to include the descriptions for the symbols as well as the barcode to identify the device.