MEDICAL DEVICE AND LABORATORY PRODUCT PROBLEM REPORTING PROGRAM

ICR 198711-0910-007

OMB: 0910-0143

Federal Form Document

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Document
Name
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ICR Details
0910-0143 198711-0910-007
Historical Active 198702-0910-006
HHS/FDA
MEDICAL DEVICE AND LABORATORY PRODUCT PROBLEM REPORTING PROGRAM
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 02/10/1988
Retrieve Notice of Action (NOA) 11/18/1987
This information collection request is approved subject to the following: FDA pursues its proposed efforts to eliminate or reduce the number of reports that either require no action or routine action that would have resulted regardless of the report. FDA should not depend on this voluntary system to monitor slight variability in frequencies of malfunctions because of its voluntary nature. FDA's assertion that its current goal of prospective health protection might be reversed to an after the fact response is misleading. Once a device receives marketing approval FDA's monitoring and enforcement activities are by definition "after the fact".
  Inventory as of this Action Requested Previously Approved
02/28/1991 02/28/1991
2,300 0 0
575 0 0
0 0 0

THIS PROGRAM PROVIDES INFORMATION NEEDED TO MONITOR THE SAFETY AND EFFECTIVENESS OF MEDICAL DEVICES AND RADIOLOGICAL PRODUCTS REGULATED BY CDRH. DATA IS VOLUNTARILY SUBMITTED BY HEALTH CARE PROFESSIONALS AND OTHER INDIVIDUALS AND IS USED TO PROTECT THE PUBLIC HEALTH THROUGH EDUCATION, REGULATORY, ADMINISTRATIVE, AND VOLUNTARY CORRECTIVE ACTION.

None
None


No

1
IC Title Form No. Form Name
MEDICAL DEVICE AND LABORATORY PRODUCT PROBLEM REPORTING PROGRAM 2519(F)

  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 2,300 0 0 0 2,300 0
Annual Time Burden (Hours) 575 0 0 0 575 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.
11/18/1987


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