Postmarket Surveillance of Medical Devices

ICR 200310-0910-010

OMB: 0910-0449

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
6135
Migrated
ICR Details
0910-0449 200310-0910-010
Historical Active 200008-0910-005
HHS/FDA
Postmarket Surveillance of Medical Devices
Extension without change of a currently approved collection   No
Regular
Approved without change 12/17/2003
Retrieve Notice of Action (NOA) 10/27/2003
  Inventory as of this Action Requested Previously Approved
12/31/2006 12/31/2006 12/31/2003
138 0 502
5,778 0 23,328
0 0 0

This proposed regulation implements the postmarket surveillance provision of Section 522 of the FD&C Act as amended by FDAMA. The regulaton provides for the collection of useful data or information necessary to protect the public health or provide safety and effectiveness information about the device.

None
None


No

1
IC Title Form No. Form Name
Postmarket Surveillance of 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 138 502 0 0 -364 0
Annual Time Burden (Hours) 5,778 23,328 0 0 -17,550 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.
10/27/2003


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