Medical Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting

ICR 200603-0910-011

OMB: 0910-0437

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0437 200603-0910-011
Historical Active 200302-0910-002
HHS/FDA
Medical Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting
Extension without change of a currently approved collection   No
Regular
Approved without change 05/12/2006
Retrieve Notice of Action (NOA) 03/31/2006
  Inventory as of this Action Requested Previously Approved
05/31/2009 05/31/2009 05/31/2006
122,325 0 37,550
138,271 0 121,685
0 0 0

This regulation will eliminate MDR reporting requirements for distributors (who are not importers) of medical devices; eliminate annual certification requirements for manufacturers and distributors (including importers) of medical devices; and reduce the frequency of user facility summary from semi-annual to annual.

None
None


No

1
IC Title Form No. Form Name
Medical Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting FDA-3417, FDA-3419

  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 122,325 37,550 0 0 84,775 0
Annual Time Burden (Hours) 138,271 121,685 0 0 16,586 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.
03/31/2006


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