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

Medical Devices; Humanitarian Use Devices

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0332 can be found here:

Documents and Forms

Document Name Document Type
0332_Guidance.pdf Other-Agency Guidance

Information Collection (IC) Details

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 814.126(b)(1)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			0332_Guidance.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 175	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	175	-17	192
Annual IC Time Burden (Hours)	16,739	-2,971	19,710
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

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