OMB control number
Product Jurisdiction and Combination Products
OMB 0910-0523 · HHS/FDA.
OMB 0910-0523
The information collection supports sponsor requests to obtain classification and primary jurisdiction designation for a product intended for FDA review. Upon determination of jurisdiction sponsors may submit appropriate marketing applications in accordance with applicable regulations.
The latest form for Product Jurisdiction and Combination Products expires 2027-01-31 and can be found here.
Latest Forms, Documents, and Supporting Material
Document Name |
|---|
Form and Instruction |
Supporting Statement A |
Supplementary Document |
Justification for No Material/Nonsubstantive Change |
Form FDA 5003 Requests for Designations: Combination Products reporting and records
0523 Product Jursdication Combo Products SSA 2023 EXT.docx
0845 GFI Combo Products Pre RFD FEB 2018.pdf
Requests for Designations: Combination Products reporting and records All Historical Document Collections
|
Approved without change |
Extension without change of a currently approved collection | 2023-11-30 | |
|
Approved without change |
Revision of a currently approved collection | 2020-11-27 | |
|
Approved with change |
No material or nonsubstantive change to a currently approved collection | 2020-10-27 | |
|
Approved without change |
Extension without change of a currently approved collection | 2019-11-15 | |
|
Approved without change |
Extension without change of a currently approved collection | 2016-09-07 | |
|
Approved without change |
Extension without change of a currently approved collection | 2013-08-20 | |
|
Approved without change |
Extension without change of a currently approved collection | 2010-04-05 | |
|
Approved without change |
Extension without change of a currently approved collection | 2007-02-21 | |
|
Approved without change |
New collection (Request for a new OMB Control Number) | 2003-10-22 |