Information Collection

Medical Devices: Medical Device Reporting, User Facility Reporting, Distributor Reporting, Manufacturer Reporting, Certification, Registration

IC 165409 under ICR 199305-0910-006 · OMB 0910-0059.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0059 can be found here:

Documents and Forms

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Information Collection (IC) Details

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IC Title:	MEDICAL DEVICES: MEDICAL DEVICE REPORTING, USER FACILITY REPORTING, DISTRIBUTOR REPORTING, MANUFACTURER REPORTING, CERTIFICATION, REGISTRATION	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.	Available Electronically?	Can Be Submitted Electronically?
Form	FDA-2891	No	No
Form	2891A, 2892	No	No
Form	3322 & 3375	No	No

Line of Business:

Subfunction:

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 44,650	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	46,800	-182,022	228,822
Annual IC Time Burden (Hours)	200,929	-77,058	277,987
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.