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Premarket Notification Submission 5100(k), Subpart E
Premarket Notification Submission 5100(k), Subpart E
OMB: 0910-0120
IC ID: 5734
OMB.report
HHS/FDA
OMB 0910-0120
ICR 200705-0910-004
IC 5734
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0120 can be found here:
2023-08-28 - No material or nonsubstantive change to a currently approved collection
2023-06-29 - Revision of a currently approved collection
Documents and Forms
Document Name
Document Type
Form 3541
Premarket Notification Submission 5100(k), Subpart E
Form and Instruction
3541 Premarket Notification [510 ( K )] Status Request and Re
Form FDA 3541.pdf
Form and Instruction
3654 Standard Data Report for 519 (K)s
Form FDA 3654.pdf
Form and Instruction
3514 CDRH Premarket Review Submission Cover Sheet
Form FDA 3514.pdf
Form and Instruction
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Premarket Notification Submission 5100(k), Subpart E
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Required to Obtain or Retain Benefits
CFR Citation:
21 CFR 800.807.87
21 CFR 800.807.81
21 CFR 800.807.92
21 CFR 800.807.93
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Form and Instruction
3541
Premarket Notification [510 ( K )] Status Request and Response
Form FDA 3541.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3654
Standard Data Report for 519 (K)s
Form FDA 3654.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3514
CDRH Premarket Review Submission Cover Sheet
Form FDA 3514.pdf
Yes
Yes
Fillable Printable
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:
3,700
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
26,206
0
0
106
0
26,100
Annual IC Time Burden (Hours)
303,528
0
0
-55,472
0
359,000
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.