Adverse Event Reporting

Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun))

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0471 can be found here:

Documents and Forms

Document Name Document Type
Form FDA 3670 Adverse Event Reporting Form and Instruction
FDA 3670 MedSun Database Additional Questions MedSun Database Additional Questions (Compiled).JPG Form and Instruction
FDA 3670 MedSun Database Contact Screen MedSun Database Contact Screen.JPG Form and Instruction
FDA 3670 MedSun Database Device Screen MedSun Database Device Screen.JPG Form and Instruction
FDA 3670 MedSun Database Event Screen MedSun Database Event Screen.JPG Form and Instruction
FDA 3670 MedSun Database Patient Screen MedSun Database Patient Screen.JPG Form and Instruction
FDA 3670 MedSun Database Test Screen MedSun Database Test Screen.JPG Form and Instruction

Information Collection (IC) Details

IC Title:	Adverse Event Reporting	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 3670	MedSun Database Additional Questions	MedSun Database Additional Questions (Compiled).JPG	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3670	MedSun Database Contact Screen	MedSun Database Contact Screen.JPG	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3670	MedSun Database Device Screen	MedSun Database Device Screen.JPG	No		Fillable Fileable
Form and Instruction	FDA 3670	MedSun Database Event Screen	MedSun Database Event Screen.JPG	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3670	MedSun Database Patient Screen	MedSun Database Patient Screen.JPG	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3670	MedSun Database Test Screen	MedSun Database Test Screen.JPG	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 250	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits, Not-for-profit institutions

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	3,750	-2,250	6,000
Annual IC Time Burden (Hours)	2,813	-1,687	4,500
Annual IC Cost Burden (Dollars)	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.