From: Robert Wolfarth [rwolfarth@ascensionortho.com]
Sent: Friday, October 04, 2002 10:19 AM
To: fdadockets@oc.fda.gov
Subject: Docket No. 02N-0405

Dear Sir or Madam:

In response to FDA's request for comment from industry on various medical device reporting (MDR) requirements, I wish to submit the following recommendation:

I recommend that an on-line, printable MedWatch form be developed.  This would reduce form completion time and eliminate postal delivery time.

Thank you.

Best regards,

Robert M. Wolfarth
Regulatory Affairs Manager
Ascension Orthopedics, Inc.
8200 Cameron Road, Suite C-140
Austin, TX  78754  USA
(orthopedic implant (device) company)