Medical Devices: Reports of Correction and Removals -- 21 CFR Part 806 (Final Rule)

ICR 199711-0910-005

OMB: 0910-0359

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
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ICR Details
0910-0359 199711-0910-005
Historical Active
HHS/FDA
Medical Devices: Reports of Correction and Removals -- 21 CFR Part 806 (Final Rule)
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 01/30/1998
Retrieve Notice of Action (NOA) 11/26/1997
  Inventory as of this Action Requested Previously Approved
01/31/2001 01/31/2001
880 0 0
13,200 0 0
0 0 0

The Federal Food, Drug, and Cosmetic Act, as amended by the Safe Medical Devices Act of 1990 and Medical Device Amendments of 1992, requires manufactures, distributors, and importers of medical devices to report promptly to FDA any correction or removal of a device undertaken by such manufacture, importer, and distributor, if the correction or removal was undertaken to reduce a risk to health posed by the device or to remedy a violation of the Act caused by the device which may present a risk of health.

None
None


No

1
IC Title Form No. Form Name
Medical Devices: Reports of Correction and Removals -- 21 CFR Part 806 (Final Rule)

  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 880 0 0 880 0 0
Annual Time Burden (Hours) 13,200 0 0 13,200 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
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.
11/26/1997


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