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Medical Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting
Medical Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting
OMB: 0910-0437
IC ID: 6116
OMB.report
HHS/FDA
OMB 0910-0437
ICR 200909-0910-006
IC 6116
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0437 can be found here:
2023-03-20 - No material or nonsubstantive change to a currently approved collection
2022-02-22 - Revision of a currently approved collection
Documents and Forms
Document Name
Document Type
Form 3419
Medical Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting
Form and Instruction
MedWatch HL7 e- Version.xls
Instruction
3419 Medical Device Reporting Annual User Facility Report
Form FDA 3419.pdf
Form and Instruction
FDA 3500A Medical device Adverse Event Report
eMDR eSubmitter Screenshots.doc
Form and Instruction
eMDR draft guidance.doc
eMDR draft guidance
IC Document
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Medical Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 803.20
21 CFR 803.19
21 CFR 803.30
21 CFR 803.32
21 CFR 803.33
21 CFR 803.40
21 CFR 803.42
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Form and Instruction
3419
Medical Device Reporting Annual User Facility Report
Form FDA 3419.pdf
Yes
Yes
Fillable Printable
Form and Instruction
FDA 3500A
Medical device Adverse Event Report
eMDR eSubmitter Screenshots.doc
Yes
Yes
Fillable Printable
Instruction
MedWatch HL7 e- Version.xls
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:
18,142
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
135,565
0
-108,972
0
0
244,537
Annual IC Time Burden (Hours)
21,525
0
-272,669
0
0
294,194
Annual IC Cost Burden (Dollars)
23,100,000
0
23,100,000
0
0
0
Documents for IC
Title
Document
Date Uploaded
eMDR draft guidance
eMDR draft guidance.doc
09/05/2009
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.