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Device corrections and removals
Medical Devices; Reports of Corrections and Removals
OMB: 0910-0359
IC ID: 5979
OMB.report
HHS/FDA
OMB 0910-0359
ICR 202309-0910-003
IC 5979
( )
Documents and Forms
Document Name
Document Type
Form e-Form/Link
Device corrections and removals
Form and Instruction
e-Form/Link Device Correction/Removal Report
0359Device Correction-Removal Report for Industry ver 02-22-23.pdf
Form and Instruction
e-Form/Link Device Correction/Removal Report
0359Device Correction-Removal Report for Industry ver 02-22-23 (002)--CDRH to APRA 10-12-23.pdf
Form and Instruction
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Device corrections and removals
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 806
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Form and Instruction
e-Form/Link
Device Correction/Removal Report
0359Device Correction-Removal Report for Industry ver 02-22-23 (002)--CDRH to APRA 10-12-23.pdf
Yes
Yes
Fillable Fileable
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Consumer Health and Safety
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
1,033
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
0 %
Approved
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
1,033
0
0
0
0
1,033
Annual IC Time Burden (Hours)
11,260
0
0
0
0
11,260
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
No associated records found
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.