Export of Medical Devices - Foreign Letters of Approval

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0264 can be found here:

Documents and Forms

Document Name Document Type
Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996.doc Other-Regulatory Guidance

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Export of Medical Devices - Foreign Letters of Approval	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-Regulatory Guidance			Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996.doc		Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 25	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	Previously Approved
Annual Number of Responses for this IC	25	5	20
Annual IC Time Burden (Hours)	63	13	50
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.