Medical Devices; Humanitarian Use Devices; 21 CFR Part 814 - Subpart H

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Information Collection (IC) Details

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IC Title:	Medical Devices; Humanitarian Use Devices; 21 CFR Part 814 - Subpart H	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 814.102 21 CFR 814.104 21 CFR 814.106 21 CFR 814.108 21 CFR 814.116(e)(3) 21 CFR 814.124(b) 21 CFR 824.126(b)(1) 21 CFR 814.126(b)(2)

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: 154	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 95 %

	Approved	Previously Approved
Annual Number of Responses for this IC	154	154
Annual IC Time Burden (Hours)	12,585	12,585
Annual IC Cost Burden (Dollars)	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.