Medical Devices; Medical 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⚠️ Notice: This information collection may be referencing outdated material.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

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

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IC Title:	Medical Devices; Medical Reporting; Manufacturer Reporting, Importer Reporting, User Facility Reporting, Distributor Reporting	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Migrated

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	FDA-3419				No	No
Form	FDA-3417				No	No

Line of Business:

Subfunction:

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 37,550	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	37,550	-2,214	39,764
Annual IC Time Burden (Hours)	121,685	30,379	91,306
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.