Information Collection

Medical Devices; Device Tracking

IC 6125 under ICR 201105-0910-002 · OMB 0910-0442.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0442 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
ucm071775.pdf Medical Device Tracking; Guidance for Industry	IC Document

IC Title:

Medical Devices; Device Tracking

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 821.25 21 CFR 821.30

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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 17,015

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 90 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	17,915	-241,262	259,177
Annual IC Time Burden (Hours)	621,279	-2,785,905	3,407,184
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
Medical Device Tracking; Guidance for Industry	ucm071775.pdf	11/18/2011

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