From: Anastas, Julia [janastas@CYGN.COM]
Sent: Thursday, July 11, 2002 2:09 PM
To: 'fdadockets@oc.fda.gov'
Subject: Comments for Public Meeting on Bar Code Requirements, 7/26/02


	On behalf of Cygnus, Inc, a medical device manufacturing company, I
would like to submit responses to selected questions listed in the Federal
Register notice of a public meeting on Bar Code Requirements for Human Drug
Products and Medical Devices.  The meeting will take place on July 26, 2002
from 9AM to 5 PM.

	B. Medical Device Questions

	1. Should medical devices carry a bar code? What information should
be included in the bar code? For example, unlike drug products, medical
devices do not have unique identifier numbers.   

	Cygnus, Inc. is implementing bar coding for our medical device for
reimbursement and logistics purposes, not because of safety concerns.
Unlike pharmaceuticals or biologics, most medical devices are not easily
confused with one another and most do not have expiration dating.  For this
reason, recommended guidelines rather than mandatory requirements may be
appropriate at this juncture.

	2. If medical devices are bar coded, should all medical devices, or
only certain devices be bar coded? For example, tongue depressors, syringes,
and crutches are medical devices, but perhaps do not need a bar code.

	Guidelines based on safety criteria would allow manufacturers to
determine whether bar codes are necessary.  Some manufacturers  that have no
safety concerns may elect to use barcodes strictly for logistical purposes.
Guidelines would encourage harmonization of bar coding standards across the
industry.

	C. General Questions and Economic Impact Questions


	2. Have you implemented bar code technology in your product line? If
so, what elements and symbology are included in the bar code?

	Cygnus uses the EAN/UCC system and recommends its use.  We use our
NHRIC number as a prefix and create our own unique identifier for each item.
This identifier is used in bar coding individual items for point of sale
(UPC) and used along with bar coded lot, quantity and expiration date on
certain packages.  Our company adheres to symbology defined by EN980.

	4. Can bar codes be produced with a dose specific unique identifying
number, lot number, and expiration date at your highest production line
speeds? 

	 Not at this time.

	Thank you.

	Julia Anastas
	Sr. Manager, Regulatory Affairs
	Cygnus, Inc., Redwood City, CA

	phone 	650-599-3543
	fax		650-639-5318