MedWatch 3500B Consumer reporting

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⚠️ Notice: This information collection may be referencing outdated material.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 3500b MedWatch 3500B Consumer reporting Form and Instruction
FDA 3500b MedWatch Consumer Reporting MedWatch 3500B Consumer Reporting.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	MedWatch 3500B Consumer reporting	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

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 3500b	MedWatch Consumer Reporting	MedWatch 3500B Consumer Reporting.pdf		Yes	Yes	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	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	11,500	11,500
Annual IC Time Burden (Hours)	4,792	4,792
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.