User Facility Annual Reporting FDA Form 3419

Medical Devices; Medical Device Reporting; Manufacturer Reporting; Importer Reporting, User Facility Reporting, Distributor Reporting

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0437 can be found here:

Documents and Forms

Document Name Document Type
Form 3419 User Facility Annual Reporting FDA Form 3419 Form and Instruction
3419 User Facility Annual Report Form User Facility Annual Report Form--FDA 3419.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	User Facility Annual Reporting FDA Form 3419	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 803.33

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	3419	User Facility Annual Report Form	User Facility Annual Report Form--FDA 3419.pdf		Yes	No	Fillable Fileable Signable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 520	Number of Respondents for Small Entity: 50

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

Percentage of Respondents Reporting Electronically: 99 %

	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	520	325	195
Annual IC Time Burden (Hours)	520	325	195
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.