OMB control number

Medical Device User Fee Cover Sheet and Device Facility User Fee Cover Sheet — Form FDA 3601 and Form 3601(a)

OMB 0910-0511 · HHS/FDA.

OMB 0910-0511

This information collection implements FDA's Medical Device User Fee Program authorized under the Federal Food, Drug, and Cosmetic Act. Respondents to the information collection are sponsors of medical devices subject to the statutory and regulatory provisions governing these products.

The latest form for Medical Device User Fee Cover Sheet and Device Facility User Fee Cover Sheet — Form FDA 3601 and Form 3601(a) expires 2028-03-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form FDA 3601 Medical Device User Fee Cover Sheet (Form FDA 3601) Form
Form FDA 3601(a) Device Facility User Fee Cover Sheet (Form FDA 3601(a)) Form
0511_Supporting Statement_2024.docx Supporting Statement A
Medical Device User Fee Cover Sheet (Form FDA 3601) Form
Notification of the intent to use an Accredited Person Other-AP Program
Requests for Information under 513(g) of the FFDCA Other-Agency Guidance
Request for Accreditation - Third Party Inspections Other-Statutory Authority
Device Facility User Fee Cover Sheet (Form FDA 3601(a)) Form

All Historical Document Collections

202401-0910-006	Revision of a currently approved collection	2024-09-30
202303-0910-002 Approved without change	No material or nonsubstantive change to a currently approved collection	2023-03-13
202107-0910-002 Approved without change	Revision of a currently approved collection	2021-09-07
201907-0910-009 Approved without change	Extension without change of a currently approved collection	2019-07-19
201708-0910-006 Approved without change	No material or nonsubstantive change to a currently approved collection	2017-08-16
201604-0910-005 Approved without change	Extension without change of a currently approved collection	2016-04-13
201302-0910-003 Approved without change	Extension without change of a currently approved collection	2013-02-08
201001-0910-015 Approved without change	Extension without change of a currently approved collection	2010-01-29
200611-0910-006 Approved without change	Extension without change of a currently approved collection	2006-11-16
200305-0910-004 Approved with change	New collection (Request for a new OMB Control Number)	2003-05-29

OMB Details

Medical Device User Fee Cover Sheet (Form FDA 3601)

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form FDA 3601

Medical Device User Fee Cover Sheet

Fillable Fileable Signable

Form

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.