MEDICAL DEVICES: MEDICAL DEVICE REPORTING, USER FACILITY REPORTING, DISTRIBUTOR REPORTING, MANUFACTURER REPORTING, CERTIFICATION, REGISTRATION

ICR 199302-0910-001

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 199302-0910-001
Historical Active 199001-0910-001
HHS/FDA
MEDICAL DEVICES: MEDICAL DEVICE REPORTING, USER FACILITY REPORTING, DISTRIBUTOR REPORTING, MANUFACTURER REPORTING, CERTIFICATION, REGISTRATION
Revision of a currently approved collection   No
Regular
Approved without change 05/04/1993
Retrieve Notice of Action (NOA) 02/04/1993
  Inventory as of this Action Requested Previously Approved
03/31/1996 03/31/1996 03/31/1993
228,822 0 2,500
277,987 0 2,500
0 0 0

THIS REGULATION REQUIRES A MANUFACTURER, IMPORTER, OR DISTRIBUTOR OR USER FACILITY OF MEDICAL DEVICES TO REGISTER AND LIST THEIR PRODUCTS WITH FDA AND REPORT TO FDA WHEN THEY POSSESS INFORMATION SUGGESTING A DEVICE HAS CAUSED OR CONTRIBUTED TO A DEATH, SERIOUS ILLNESS, OR SERIO INJURY.

None
None


No

1
IC Title Form No. Form Name
MEDICAL DEVICES: MEDICAL DEVICE REPORTING, USER FACILITY REPORTING, DISTRIBUTOR REPORTING, MANUFACTURER REPORTING, CERTIFICATION, REGISTRATION FDA-2891, 2891A, 2892, 3322 & 3375

  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 228,822 2,500 0 55,604 170,718 0
Annual Time Burden (Hours) 277,987 2,500 0 67,683 207,804 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
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.
02/04/1993


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