Docket Management
Docket: 03N-0038 - Medical Device User Fee Cover Sheet; Form FDA 3601; Agency Information Collection Activities
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Mr. Michael Larsen Date/Time 2003-02-27 10:38:19
Organization Criticare Systems, Inc.
Category Company

Comments for FDA General
3. What are ways to enhance the quality, utility, and clarity of the information to be collected? We currently have 2 510(k) submissions pending. Both are subject to user fees. The Form 3601 should have a mandatory data field which describes the submission towards which the particular fee is directed. Adding an additional, optional K number field would remove all ambiguity.

EC -1