Medical Product Reporting Network (MedSun)

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⚠️ Notice: This information collection may be referencing outdated material.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 Medical Product Reporting Network (MedSun) Form and Instruction
FDA 3670 MedSun FDA e-Form 3670 MedSun.pdf medsun.fda.gov/FDA/ Form and Instruction

Information Collection (IC) Details

IC Title:	Medical Product Reporting Network (MedSun)	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	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 3670	MedSun	FDA e-Form 3670 MedSun.pdf	https://medsun.fda.gov/FDA/	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 300	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: 99 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	5,400	1,650	3,750
Annual IC Time Burden (Hours)	2,700	-113	2,813
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.