RECLASSIFICATION PETITIONS FOR MEDICAL DEVICES

ICR 198511-0910-005

OMB: 0910-0138

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
109696
Migrated
ICR Details
0910-0138 198511-0910-005
Historical Active 198408-0910-006
HHS/FDA
RECLASSIFICATION PETITIONS FOR MEDICAL DEVICES
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 01/13/1986
Retrieve Notice of Action (NOA) 11/13/1985
  Inventory as of this Action Requested Previously Approved
06/30/1987 06/30/1987
5 0 0
2,000 0 0
0 0 0

A RECLASSIFICATION PETITIO ALLOWS MANUFACTURERS AND OTHERS TO REQUEST A CHANGE IN THE REGULATORY CONTROL (CLASS) OF A MEDICAL DEVICE. THE PETITION MUST PROVIDE ADEQUA INFORMATION DEMONSTRATING THAT THE REQUESTED CHANGE WILL PROVIDE, OR I NECESSARY TO PROVIDE, REASONABLE ASSURANCE OF THE SAFETY AND EFFECTIVENESS OF A DEVICE.

None
None


No

1
IC Title Form No. Form Name
RECLASSIFICATION PETITIONS FOR MEDICAL DEVICES

  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 5 0 0 0 5 0
Annual Time Burden (Hours) 2,000 0 0 0 2,000 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.
11/13/1985


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