MedWatch 3500 for VOLUNTARY reporting of adverse events, product problems and product use errors

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⚠️ Notice: This information collection may be referencing outdated material.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 MedWatch 3500 for VOLUNTARY reporting of adverse events, product problems and product use errors Form and Instruction
FDA 3500 MedWatch for VOLUNTARY reporting of adverse events, prod Medwatch 3500 VOLUNTARY.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	MedWatch 3500 for VOLUNTARY reporting of adverse events, product problems and product use errors	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 301

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	MedWatch for VOLUNTARY reporting of adverse events, product problems and product use errors	Medwatch 3500 VOLUNTARY.pdf		No	No	Fillable Fileable

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 22,700	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 20 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	22,700	-613,416	636,116
Annual IC Time Burden (Hours)	13,620	-668,863	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.