OMB control number
Medical Devices; Reports of Corrections and Removals
OMB 0910-0359 ยท HHS/FDA.
OMB 0910-0359
The information collection requirements in 21 CFR Part 806 require each device manufacturer or importer to submit a written report to FDA of any action to correct or remove a device which may present a risk to health within 10-working days of initiating such correction or removal. The Information Collection also requires that each device manufacturer or importer of a device who initiates a correction or removal of a device that is not required to be reported to FDA, shall keep a record of such correction or removal.
The latest form for Medical Devices; Reports of Corrections and Removals expires 2026-10-31 and is listed under ICR 202309-0910-003.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 Form e-Form/Link Device corrections and removals | Form and Instruction |
 0359 Corrections and Removals adding form SSA 2023 REV.docx | Supporting Statement A |
 Device corrections and removals |
Form and Instruction |
| eSubmitter participants |
Other-eSubmitter screenshots |
| Combination product reports and recordkeeping |
Information collection |
All Historical Document Collections
OMB Details
Device corrections and removals
Federal Enterprise Architecture: Health - Consumer Health and Safety
| Form | Name | Electronic access | Type |
|---|---|---|---|
| Form e-Form/Link | Device Correction/Removal Report | Fillable Fileable | Form and instruction |
Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.