Docket: 03N-0038 - Medical Device User Fee Cover Sheet; Form FDA 3601; Agency Information Collection Activities Comment Number: EC -1
Accepted - Volume 1
Mr. Michael Larsen
Criticare Systems, Inc.
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.