From: joel.kent@us.datex-ohmeda.com
Sent: Tuesday, April 22, 2003 2:29 PM
To: fdadockets@oc.fda.gov
Cc: joel.kent@us.datex-ohmeda.com
Subject: Comments: 03N-0094

Importance: High

In response to The Food and Drug Administration (FDA) publishing its annual
guidance document agenda (Docket 03N-0094) I am submitting
the following items and requesting they be added to the annual guidance document agenda:

1. Policy Guidance on the use of Symbols for Medical Devices in lieu of English.

2. Guidance on the use of ISO Risk Management for Medical Devices
ISO 14971:2000

3. Guidance on criteria for determing when Software is a medical device

4. Clarification of labeling requirement for PVC devices which contain DEHP

5. Guidance for obtaining information on the status of FOI requests made to the FDA

6. Guidance for content of Premarket notification 510(k) summary and suggest adding a requirement to publish the general
 device specifications as part of the 510(k) Summary device description section in order to faciltate obtaining essential predicate device
information that may not otherwise be available or is only available through FOI requests that can take several years




Joel Kent
Datex-Ohmeda Division, Instrumentarium Corp.
phone: 781-449-8685
joel.kent@us.datex-ohmeda.com