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Premarket Approval of Medical Devices - 21 CFR Part 814
Premarket Approval of Medical Devices - 21 CFR Part 814
OMB: 0910-0231
IC ID: 5826
OMB.report
HHS/FDA
OMB 0910-0231
ICR 201912-0910-005
IC 5826
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0231 can be found here:
2023-03-30 - Revision of a currently approved collection
2020-03-20 - Extension without change of a currently approved collection
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:
Premarket Approval of Medical Devices - 21 CFR Part 814
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Unchanged
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 814.15
21 CFR 814.20
21 CFR 814.84
21 CFR 814.37
21 CFR 814.82
21 CFR 814.39
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:
4,846
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
95 %
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
4,846
0
0
0
0
4,846
Annual IC Time Burden (Hours)
350,562
0
0
0
0
350,562
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.