Information Collection

Form 3500A Medwatch for user facilities, importers, distributors, and manufacturers for MANDATORY reporting

IC 200368 under ICR 201112-0910-001 · OMB 0910-0291.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form FDA 3500A Form 3500A Medwatch for user facilities, importers, distributors, and manufacturers for MANDATORY reporting	Form and Instruction
FDA 3500A Medwatch for use by user-facilities, importers, distribu Modified FDA 3500A 12-2011.pdf	Form and Instruction

IC Title:

Form 3500A Medwatch for 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: Voluntary

CFR Citation:

Information Collection Instruments:

table that charts list of 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	Modified FDA 3500A 12-2011.pdf		Yes	Yes	Fillable Fileable Signable

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 2,600

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 20 %

table that charts list of burden
	Requested	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	744,413	744,413
Annual IC Time Burden (Hours)	839,430	839,430
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
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.