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
Questions
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