Medical Devices: Medical Device Reporting, User Facility Reporting, Manufacturer Reporting, Certification, Registration (Final Rule)

ICR 199512-0910-001

OMB: 0910-0059

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0059 199512-0910-001
Historical Active 199305-0910-006
HHS/FDA
Medical Devices: Medical Device Reporting, User Facility Reporting, Manufacturer Reporting, Certification, Registration (Final Rule)
Revision of a currently approved collection   No
Regular
Approved without change 02/23/1996
Retrieve Notice of Action (NOA) 12/12/1995
This package is approved contingent upon FDA making the changes described in the their faxes of February 14, 20, 22, 1996.
  Inventory as of this Action Requested Previously Approved
02/28/1999 02/28/1999 03/31/1996
127,900 0 46,800
188,110 0 200,929
68,280,000 0 0

This regulation requires medical device user facilities, manufacturers, and U.S. agents of foreign manufacturers to report any deaths, serious injuries, and certain malfunctions related to medical devices. This is a final rule based upon the proposed rule approved under information collection 0910-0059.

None
None


No

1
IC Title Form No. Form Name
Medical Devices: Medical Device Reporting, User Facility Reporting, Manufacturer Reporting, Certification, Registration (Final Rule) 3417, 3419, 3381, 2891, 2891A, 2892

  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 127,900 46,800 0 81,100 0 0
Annual Time Burden (Hours) 188,110 200,929 0 -12,819 0 0
Annual Cost Burden (Dollars) 68,280,000 0 0 68,280,000 0 0
No
Yes

$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.
12/12/1995


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