Medical Device Labeling Regulations

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Documents and Forms

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Information Collection (IC) Details

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IC Title:	Medical Device Labeling Regulations	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 800.10 (a)(3) 21 CFR 800.12(c) 21 CFR 800.10(b)(2) 21 CFR 801.1 21 CFR 801.5 21 CFR 801.61 21 CFR 801.62 21 CFR 801.109 21 CFR 801.110 21 CFR 801.150(e) 21 CFR 801.405(b)(1) 21 CFR 801.405(c) 21 CFR 801.420(c)(1&4) 21 CFR 800.421(b&c) 21 CFR 801.430(d) 21 CFR 430(e)(2) 21 CFR 801.430(f) 21 CFR 801.435(b,c & h) 21 CFR 809.10(a & b) 21 CFR 809.10(d)(1) 21 CFR 809.10(e) 21 CFR 809.10(f) 21 CFR 809.30(d) 21 CFR 801.150(a)(2) 21 CFR 801.410(e) 21 CFR 801.410(f) 21 CFR 801.421(d) 21 CFR 801.435(g) (To search for a specific CFR, visit the Code of Federal Regulations.)

Information Collection 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: 102,510	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	2,432,136	45,149	2,386,987
Annual IC Time Burden (Hours)	3,784,684	164,582	3,620,102
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

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