Form 3500 Consumer Reporting Form

MedWatch: The FDA Medical Products Reporting Program

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0291 can be found here:

Documents and Forms

Document Name Document Type
Form FDA 3500 Form 3500 Consumer Reporting Form Form and Instruction
FDA 3500 FDA Medwatch Consumer Reporting Form MedWatch Form 3500 Reporting Form 090911.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Form 3500 Consumer Reporting Form	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 3500	FDA Medwatch Consumer Reporting Form	MedWatch Form 3500 Reporting Form 090911.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 34,296	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 20 %

	Requested	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	34,296	-601,820	636,116
Annual IC Time Burden (Hours)	20,577	-661,906	682,483
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.