MEDICAL DEVICE CONFORMANCE ASSESSMENT TO VOLUNTARY STANDARDS

ICR 198905-0910-019

OMB: 0910-0253

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0253 198905-0910-019
Historical Active 198901-0910-002
HHS/FDA
MEDICAL DEVICE CONFORMANCE ASSESSMENT TO VOLUNTARY STANDARDS
No material or nonsubstantive change to a currently approved collection   No
Emergency 05/23/1989
Approved with change 05/23/1989
Retrieve Notice of Action (NOA) 05/23/1989
  Inventory as of this Action Requested Previously Approved
12/31/1991 12/31/1991 03/31/1990
200 0 200
800 0 800
0 0 0

THE CONFORMANCE ASSESSMENT PROGRAM WILL EVALUATE THE EXTENT THAT CERTAIN HIGH PRIORITY MEDICAL DEVICES ADHERE TO VOLUNTARY STANDARDS AND WILL ASSESS THE IMPACT OF THESE ON THE SAFETY AND EFFECTIVENESS OF THESE DEVICES. CONFORMANCE WILL BE ACCOMPLISHED BY REVIEW AND ANALYSIS OF INFORMATION OBTAINED FROM MANUFACTURERS.

None
None


No

1
IC Title Form No. Form Name
MEDICAL DEVICE CONFORMANCE ASSESSMENT TO VOLUNTARY STANDARDS

  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 200 200 0 0 0 0
Annual Time Burden (Hours) 800 800 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.
05/23/1989


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