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Postmarket Surveillance of Medical Devices: submissions, changes, waivers, exemption requests, reports
Postmarket Surveillance of Medical Devices
OMB: 0910-0449
IC ID: 6135
OMB.report
HHS/FDA
OMB 0910-0449
ICR 202203-0910-007
IC 6135
( )
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:
Postmarket Surveillance of Medical Devices: submissions, changes, waivers, exemption requests, reports
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 822
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
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:
32
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
66
0
0
-90
0
156
Annual IC Time Burden (Hours)
3,008
0
0
-4,080
0
7,088
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.