Medical Product Reporting Network (MedSun)

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

Documents and Forms

Document Name Document Type
Form FDA 3670 Medical Product Reporting Network (MedSun) Form and Instruction
FDA 3670 MedSun 0471_eform_MedSun.pdf medsun.fda.gov/FDA/ Form and Instruction
FDA 3670 MedSun 0471_eform_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	0471_eform_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	Previously Approved
Annual Number of Responses for this IC	5,400	5,400
Annual IC Time Burden (Hours)	2,700	2,700
Annual IC Cost Burden (Dollars)	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.