CDRH Export Certificate (FDA 3613, 3613a, 3613c)

Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0498 can be found here:

Documents and Forms

Document Name Document Type
Form FDA 3613 CDRH Export Certificate (FDA 3613, 3613a, 3613c) Form and Instruction
FDA 3613 Supplementary Information Certificate to Foreign Governm FDA-3613.pdf Form and Instruction
FDA 3613a Supplementary Information Certificate of Exportability R FDA-3613a.pdf Form and Instruction
FDA 3613c Supplementary Information Non-Clinical Research Use Only FDA-3613c.pdf Form and Instruction
FDA 3613g SUPPLEMENTARY INFORMATION CERTIFICATE FOR DEVICE NOT EXP draft form FDA 3613g.docx Form and Instruction

Information Collection (IC) Details

IC Title:	CDRH Export Certificate (FDA 3613, 3613a, 3613c)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 3613	Supplementary Information Certificate to Foreign Government Requests	FDA-3613.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3613a	Supplementary Information Certificate of Exportability Requests	FDA-3613a.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3613c	Supplementary Information Non-Clinical Research Use Only Certificate	FDA-3613c.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3613g	SUPPLEMENTARY INFORMATION CERTIFICATE FOR DEVICE NOT EXPORTED FROM THE UNITED STATES REQUESTS	draft form FDA 3613g.docx	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 11,175	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	Previously Approved
Annual Number of Responses for this IC	11,175	11,175
Annual IC Time Burden (Hours)	22,350	22,350
Annual IC Cost Burden (Dollars)	1,955,625	1,955,625

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.