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Reporting; Voluntary Malfunction Summary Reporting Program
Medical Device Reporting
OMB: 0910-0437
IC ID: 231473
OMB.report
HHS/FDA
OMB 0910-0437
ICR 202412-0910-004
IC 231473
( )
Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Reporting; Voluntary Malfunction Summary Reporting Program
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Voluntary
CFR Citation:
21 CFR 4
21 CFR 803
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Other-FDA notification and order, "Medical Devices and Device-led Combination Products: Voluntary Malfunction Summary Reporting Program for Manufacturers"
Yes
Yes
Fillable Fileable
Other-Agency Guidance, "Voluntary Malfunction Summary Reporting Prgram for Manufacturers"
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:
44
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
99 %
Requested
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
2,503
0
0
-44,072
46,575
0
Annual IC Time Burden (Hours)
250
0
0
-4,408
4,658
0
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.