OMB control number
Product Jurisdiction and Combination Products
OMB 0910-0523 ยท 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 is listed under ICR 202311-0910-014.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 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 |