MEDICAL DEVICE AND LABORATORY PRODUCT PROBLEM REPORTING PROGRAM

ICR 198412-0910-007

OMB: 0910-0143

Federal Form Document

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Document
Name
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ICR Details
0910-0143 198412-0910-007
Historical Active 198312-0910-002
HHS/FDA
MEDICAL DEVICE AND LABORATORY PRODUCT PROBLEM REPORTING PROGRAM
Revision of a currently approved collection   No
Regular
Approved without change 03/12/1985
Retrieve Notice of Action (NOA) 12/19/1984
THIS INFORMATION COLLECTION APPROVED THROUGH 12/85. UPON RESUBMISSION FDA MUST SUBMIT A REPORT BASED UPON DATA COLLECTION THROUGH SEPT. 1985 DETAILING THE EXTENT TO WHICH THE DATA COLLECTED FROM THE DEN SYSTEM OVERLAPS AND DUPLICATES DATA RECEIVED UNDER THE MDR SYSTEM AND A COMPLETE EXPLANATION OF CORRECTIVE ACTIONS BASED SOLEY UPON DEN (AS OPPOSED TO MDR) REPORTS. FDA MUST SUBMIT EITHER 1) A PROPOSAL TO DISCONTINUE THE REPORTING SYSTEM OR 2) A PLAN TO MODIFY THE SYSTEM IN LIGHT OF THE FINDINGS IN THE REPORT ABOVE. ANY SUCH PLAN MUST CONTAIN SPECIFICATIONS FOR ALTERING THE CURRENT CONTRACT EFFECTIVE NOT LATER THAN APRIL 1, 1986.
  Inventory as of this Action Requested Previously Approved
12/31/1986 12/31/1986 12/31/1984
2,500 0 2,400
750 0 600
0 0 0

THIS PROGRAM IS FDA'S PRIMARY SOURCE OF INCIDENT DATA CONCERNING THE SAFETY AND EFFECTIVENESS OF MEDICAL DEVICES. HEALTH CARE PROFESSIONAL (PHYSICIANS, NURSES, ETC.) USE THIS FORM TO VOLUNTARILY REPORT DEATHS, INJURIES, HAZARDS, AND OTHER DEVICE PROBLEMS. THESE REPORTS A USED TO HELP FDA PROTECT THE PUBLIC HEALTH VIA COMPLIANCE AND USER EDUCATION.

None
None


No

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

  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 2,500 2,400 0 0 100 0
Annual Time Burden (Hours) 750 600 0 0 150 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.
12/19/1984


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