Information Collection

Medical Devices: Medical Device Reporting, User Facility Reporting, Manufacturer Reporting, Certification, Registration (Final Rule)

IC 5710 under ICR 199512-0910-001 · 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⚠️ Notice: This information collection may be referencing outdated material.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, Manufacturer Reporting, Certification, Registration (Final Rule)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Migrated

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Available Electronically?	Can Be Submitted Electronically?
Form	3419	No	No
Form	2892	No	No
Form	2891	No	No
Form	3417	No	No
Form	2891A	No	No
Form	3381	No	No

Line of Business:

Subfunction:

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 72,905	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	127,900	81,100	46,800
Annual IC Time Burden (Hours)	188,110	-12,819	200,929
Annual IC Cost Burden (Dollars)	68,280,000	68,280,000	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.