Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements

Medical Devices; Humanitarian Use Devices

Documents and Forms

Document Name Document Type
Humanitarian Device Exemption (HDE) Program - Guidance for Industry and Food and Drug Administration Staff.pdf Other-Guidance; Humanitarian Device Exemption (HDE) Program - Guidance for Industry and Food and Drug Administration Staff

Information Collection (IC) Details

IC Title:	Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance; Humanitarian Device Exemption (HDE) Program - Guidance for Industry and Food and Drug Administration Staff			Humanitarian Device Exemption (HDE) Program - Guidance for Industry and Food and Drug Administration Staff.pdf		Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 5	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Change Due to Potential Violation of the PRA
Annual Number of Responses for this IC	5	5
Annual IC Time Burden (Hours)	360	360
Annual IC Cost Burden (Dollars)	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.