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Reclassification Petitions for Medical Devices
Reclassification Petitions for Medical Devices
OMB: 0910-0138
IC ID: 5757
OMB.report
HHS/FDA
OMB 0910-0138
ICR 201806-0910-010
IC 5757
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0138 can be found here:
2022-01-26 - Extension without change of a currently approved collection
2019-01-30 - Revision of a currently approved collection
Documents and Forms
Document Name
Document Type
Form 3429
Reclassification Petitions for Medical Devices
Form and Instruction
3429 FDA Form 3429
Form 3429.pdf
Form and Instruction
3427 FDA Form 3427
Form 3427.pdf
Form and Instruction
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Reclassification Petitions for Medical Devices
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Voluntary
CFR Citation:
21 CFR 860.123
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Form and Instruction
3429
FDA Form 3429
Form 3429.pdf
Yes
Yes
Fillable Printable
Form and Instruction
3427
FDA Form 3427
Form 3427.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:
6
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
6
0
0
0
0
6
Annual IC Time Burden (Hours)
3,000
0
0
0
0
3,000
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.