Request for Determination of Eligibility Criteria--613(b) of FDASIA

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

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0661 can be found here:

Documents and Forms

Document Name Document Type
HDE Guidance.pdf www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm110203.pdf Other-Guidance

Information Collection (IC) Details

IC Title:	Request for Determination of Eligibility Criteria--613(b) of FDASIA	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			HDE Guidance.pdf	http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm110203.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: 2	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	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	2	2
Annual IC Time Burden (Hours)	20	20
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.