Product Jurisdiction and Combination Products

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 2023-12-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form FDA 5003 Requests for Designations: Combination Products reporting and records Form and Instruction
0523 Product Jursdication Combo Products SSA 2023 EXT.docx Supporting Statement A
0845 GFI Combo Products Pre RFD FEB 2018.pdf Supplementary Document
0523 Change Request for 0845 OCT 2020.docx Justification for No Material/Nonsubstantive Change
Requests for Designations: Combination Products reporting and records Form and Instruction

All Historical Document Collections

202311-0910-014 Approved without change	Extension without change of a currently approved collection	2023-11-30
202011-0910-009 Approved without change	Revision of a currently approved collection	2020-11-27
202010-0910-010 Approved with change	No material or nonsubstantive change to a currently approved collection	2020-10-27
201910-0910-004 Approved without change	Extension without change of a currently approved collection	2019-11-15
201608-0910-013 Approved without change	Extension without change of a currently approved collection	2016-09-07
201308-0910-004 Approved without change	Extension without change of a currently approved collection	2013-08-20
201004-0910-002 Approved without change	Extension without change of a currently approved collection	2010-04-05
200702-0910-006 Approved without change	Extension without change of a currently approved collection	2007-02-21
200310-0910-006 Approved without change	New collection (Request for a new OMB Control Number)	2003-10-22