Export of Medical Devices - Foreign Letters of Approval

ICR 200308-0910-002

OMB: 0910-0264

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
5838
Migrated
ICR Details
0910-0264 200308-0910-002
Historical Active 200009-0910-001
HHS/FDA
Export of Medical Devices - Foreign Letters of Approval
Extension without change of a currently approved collection   No
Regular
Approved without change 11/17/2003
Retrieve Notice of Action (NOA) 08/25/2003
  Inventory as of this Action Requested Previously Approved
11/30/2006 11/30/2006 11/30/2003
20 0 20
50 0 50
0 0 0

The FDA has the statutory authority under sections CFR Part Section 801(e)(2) or the Act requires that a determination be made that the exportation of an unapproved medical device has the approval of the foreign country to which it is intended for export, i.e., that is it not in conflict with the laws of the country to which it is intended for export and/or has the approval of the foreign country. In order to make such a determination, the manufacturer/exporter is required to obtain a letter from the foreign government approving the importation of the medical device in question into the country. An.......

None
None


No

1
IC Title Form No. Form Name
Export of Medical Devices - Foreign Letters of Approval

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 20 20 0 0 0 0
Annual Time Burden (Hours) 50 50 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
08/25/2003


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