MedWatch 3500a for use by user-facilities, importers, distributors and manufacturers for MANDATORY 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⚠️ Notice: This information collection may be referencing outdated material.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 3500a MedWatch 3500a for use by user-facilities, importers, distributors and manufacturers for MANDATORY reporting Form and Instruction
FDA 3500a MedWatch (for use by user-facilities, importers, distrib MedWatch 3500a MANDATORY reporting.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	MedWatch 3500a for use by user-facilities, importers, distributors and manufacturers for MANDATORY reporting	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

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 3500a	MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting	MedWatch 3500a MANDATORY 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: 37,280	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
Annual Number of Responses for this IC	752,573	752,573
Annual IC Time Burden (Hours)	835,173	835,173
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.