Information Collection

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

IC 5922 under ICR 202101-0910-008 · OMB 0910-0332.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
0332_Guidance.pdf	Other-Agency Guidance
0332_Guidance.pdf	Other-Agency Guidance

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 814.108 21 CFR 814.116 21 CFR 814.124 21 CFR 814.126 21 CFR 814.106 21 CFR 814.102 21 CFR 814.104

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
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: 213

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	213	38	175
Annual IC Time Burden (Hours)	22,542	5,803	16,739
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
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.